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DTSTART;TZID=America/Chicago:20240814T120000
DTEND;TZID=America/Chicago:20240814T130000
DTSTAMP:20240815T221931Z
CREATED:20240724T231756Z
LAST-MODIFIED:20240815T221931Z
UID:6285-1723636800-1723640400@criterionedge.com
SUMMARY:Emerging Trends in Global Regulations: Insights Into More Efficient Regulatory Writing Practices
DESCRIPTION:Join us for an insightful and interactive webinar where we explore the ever-evolving landscape of global regulatory trends and their impact on information across all industries. As regulations governing product development\, agency interactions\, and filing for product approvals become increasingly complex and geographically diverse\, regulatory professionals and medical writers must adapt to ensure the compliance\, clarity and effectiveness of their documentation to meet the intended needs. This session will equip you with the background and practical insights needed to effectively understand and adapt to these regulatory changes.   \nLearning Objectives   \n\nRegulations then and now: Examine the historical and ongoing changes in global regulations and how these regulatory evolutions have reshaped the structure and content of key regulatory reports. \n\n\nRegional differences? Gain insights into how regional regulatory variations influence writing practices and help you understand the needs of the intended audience. \n\n\nWhat is the impact? Understand how these regulatory evolutions have reshaped the structure and content of key regulatory reports and documents. \n\n\nPractical strategies that support writing efficiency: Learn strategies to tailor your internal writing processes to meet the expectations and requirements of different geographic audiences to ensure your documents remain relevant and compliant.  \n\n  \nWho Should Attend and Why?  \nThis webinar is ideal for regulatory professionals\, regulatory writers\, medical writers\, compliance officers\, and anyone involved in the preparation and review of regulatory documentation who want to know more about how to:  \n\nStay abreast of how evolving regulatory requirements can affect your internal processes and written documents and reports. \n\n\nIdentify new strategies to efficiently produce compliant\, high-quality regulatory documents. \n\n\nLearn from experts with extensive experience producing documents and reports for a variety of global regulatory authorities. \n\n  \nWATCH NOW
URL:https://criterionedge.com/event/emerging-trends-in-global-regulations-insights-into-more-efficient-regulatory-writing-practices/
LOCATION:Webinar\, United States
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Webinar-14-8.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20240731T120000
DTEND;TZID=America/Chicago:20240731T130000
DTSTAMP:20240815T202124Z
CREATED:20240708T164629Z
LAST-MODIFIED:20240815T202124Z
UID:6193-1722427200-1722430800@criterionedge.com
SUMMARY:Pharma in Focus: The Role of Real-World Evidence (RWE) in Regulatory Submissions
DESCRIPTION:In this webinar\, we will explore the strategic use of Real-World Evidence (RWE) throughout product development. Participants will learn about the integration of RWE from various sources and how it can be used to bolster regulatory submissions. \nLearning Objectives: \n\nUnderstand the sources of Real-World Data (RWD) which are used to generate RWE\nExplore the main uses of RWE throughout the development[SG1]  process\nIdentify strengths and pitfalls when using RWE in regulatory submissions\n\nWATCH NOW
URL:https://criterionedge.com/event/pharma-in-focus-the-role-of-real-world-evidence-rwe-in-regulatory-submissions/
LOCATION:Webinar\, United States
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/July-31-2024-v2.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20240717T120000
DTEND;TZID=America/Chicago:20240717T130000
DTSTAMP:20240815T202522Z
CREATED:20240618T193655Z
LAST-MODIFIED:20240815T202522Z
UID:5811-1721217600-1721221200@criterionedge.com
SUMMARY:Trending Topics: From the AI Act to Orphan Devices\, Key Takeaways from RAPS EU Convergence 2024
DESCRIPTION:Welcome to our new Trending Topics webinar series! Each webinar in this series will present key trending topics\, late-breaking regulatory news and other hot-button topics from medical and in vitro device industry leaders. Tap into the critical conversations that are shaping the future of the MedTech industry and join us as we explore current issues\, trending conversations and decisions impacting the MedTech regulatory space. \nIn this webinar\, we will discuss a few of the key trending topics and issues discussed at the RAPS EU Convergence conference in Berlin. Topics include: \n1. The AI Act and MDR: identify the challenges\, incompatibilities and conflicts that arise from applying both frameworks to AI-based medical devices.\n2. Innovative and Orphan Devices: an expert panel suggests developing MDR special conformity assessment pathways to support the unique regulatory challenges faced by orphan and innovative medical devices.\n3. Notified Body Acknowledge Challenges: from inconsistent opinions to EUDAMED delays\, notified bodies continue to face numerous challenges in the current regulatory landscape. What can be done?\n4. The Impact of “massive procrastination” of MDR and IVDR Dossier Submissions: notified body experts are concerned at the potential constraints to future device availability as applications to the Notified Bodies decline in the wake of deadline extensions.\n5. Updates from the IMDRF Working Groups: review the latest updates to the scope and objectives a broad range of guidance documents on topics ranging from artificial intelligence / machine learning (AI/ML)\, good regulatory review practices\, adverse event (AE) terminology\, quality management systems\, personalized medical devices\, and software as a medical device\, and discuss their achievements and challenges. \nWATCH NOW
URL:https://criterionedge.com/event/trending-topics-from-the-ai-act-to-orphan-devices-key-takeaways-from-raps-eu-convergence-2024/
LOCATION:Webinar\, United States
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/July-17-2024.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20240625T130000
DTEND;TZID=America/Chicago:20240625T140000
DTSTAMP:20240815T202621Z
CREATED:20240606T151732Z
LAST-MODIFIED:20240815T202621Z
UID:5546-1719320400-1719324000@criterionedge.com
SUMMARY:Considerations for Companion Diagnostics: Lessons Learned and Key Takeaways from DIA 2024
DESCRIPTION:The In Vitro Diagnostics Regulation (IVDR) took effect in May 2022 and has introduced substantial changes in the regulatory framework for in vitro diagnostic medical devices (IVDs) in Europe. IVD manufacturers are expected to meet more rigorous standards for clinical evidence\, with up to 80% of IVDs requiring Notified Body certificates under IVDR. \nDr. Sarah Chavez\, Criterion Edge Director of IVD Writing Services\, will discuss key insider insights gleaned from the 2024 DIA meeting to share and discuss the key take-aways from the Symposium\, including clinical evidence requirements and strategies to keep your report writing and data collection on track. \nJoin us for this webinar to discuss differences in EU and US regulations for IVD clinical performance studies and potential implications for companion diagnostic developers. The goals of this webinar are to: \n\nUnderstand how new regulatory requirements apply to CDx and what are potential implications from both the IVD and Pharma partners’ perspectives.\nDevelop a strategic approach to ensure compliance with IVDR requirements for CDx\, covering essential aspects such as quality management\, documentation\, and early interactions with your notified body.\nAddress common challenges faced during the implementation of IVDR requirements for CDx\, exploring potential solutions and proactive measures to streamline the regulatory compliance process.\n\nWATCH NOW
URL:https://criterionedge.com/event/considerations-for-companion-diagnostics-lessons-learned-and-key-takeaways-from-dia-2024/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/June-25-2024.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20240605T120000
DTEND;TZID=America/Chicago:20240605T130000
DTSTAMP:20240815T202717Z
CREATED:20240522T170848Z
LAST-MODIFIED:20240815T202717Z
UID:5175-1717588800-1717592400@criterionedge.com
SUMMARY:Understanding FDA: Essentials for Briefing Books in Pre-IND\, Pre-NDA\, and Pre-BLA Meetings
DESCRIPTION:Join Criterion Edge on June 5th\, 2024\, at 12 PM CST for an enlightening session with Geoff Fatzinger\, our Senior Regulatory Consultant. Dive deep into the essentials of FDA interactions in our webinar: “Understanding FDA: Essentials for Briefing Books in Pre-IND\, Pre-NDA\, and Pre-BLA Meetings.” Uncover the intricacies of FDA expectations and learn how to craft effective briefing books tailored for success in pre-IND\, pre-NDA\, and pre-BLA meetings. From interpreting FDA requirements to tailoring your submissions\, this webinar is your gateway to mastering FDA regulatory engagements. \nLearning Objectives: \nInterpreting FDA Expectations:\n● Develop a clear understanding of the FDA’s expectations during pre-IND\, pre-NDA\, and pre-BLA interactions.\n● Navigate the nuances of FDA requirements for compliance. \nBuilding Effective Briefing Books:\n● Identify and comprehend the key components integral to crafting briefing books.\n● Learn best practices for organizing information to facilitate communication with the FDA. \nTailoring Briefing Books for FDA Meetings:\n● Explore considerations when tailoring briefing books to align with the FDA’s unique review processes.\n● Understand how to address FDA preferences and requirements for optimized submissions. \nAchieving Success in FDA Interactions:\n● Overcome common challenges encountered in FDA meetings and briefing book preparation.\n● Gain insights into practical strategies for navigating the FDA regulatory landscape. \nJoin us for this informative webinar on FDA interactions\, where our expert will share valuable insights to enhance your briefing book preparation for successful engagements with the FDA. \nWATCH NOW
URL:https://criterionedge.com/event/understanding-fda-essentials-for-briefing-books-in-pre-ind-pre-nda-and-pre-bla-meetings/
LOCATION:Webinar\, United States
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/June-5-2024.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20240522T130000
DTEND;TZID=America/Chicago:20240522T140000
DTSTAMP:20240815T202821Z
CREATED:20240502T193435Z
LAST-MODIFIED:20240815T202821Z
UID:4841-1716382800-1716386400@criterionedge.com
SUMMARY:IVDR in Focus: Tips for Performance Evaluation Planning to Support Your Transition from IVDD to IVDR
DESCRIPTION:While the concept of a “performance evaluation” hasn’t changed much over the past two decades\, IVDR requirements regarding the amount and extent of technical documentation have significantly changed compared to the IVDD. Annex XIII of the IVDR specifies the contents of two new documents: the performance evaluation plan (PEP) and the performance evaluation report (PER). \nTo help manufacturers prepare and comply with the IVDR\, we have compiled some tips for developing and implementing a successful PEP as you prepare for your IVDR submissions. \nLearning Objectives: \n\nDescribe the scope and objectives of the PEP\, including considerations to identify the clinical claims\, the target population\, the clinical conditions\, the comparators\, and the endpoints.\nReview how to conduct a comprehensive systematic literature review\, a critical component of the PEP which provides the basis for the clinical evidence\, both favorable and unfavorable.\nDiscuss strategies to prepare a detailed scientific validity report (SVR)\, a new requirement under the IVDR to provide a clear rationale and scientific justification for the choice of the analyte or marker\, as well as the evidence of its association with the clinical condition or physiological state.\nDefine the requirements of the analytical performance report (APR)\, another new requirement under the IVDR which seeks to demonstrate the analytical performance of the IVD in terms of its ability to correctly measure the analyte or marker.\nClarify the expectations for sufficient clinical data contained within the clinical performance report (CPR)\, a key requirement under the IVDR that demonstrates the clinical performance of the IVD in terms of its ability to correctly identify or predict the clinical condition or physiological state of the target population\n\nWho is this webinar for?\nThose Regulatory\, Quality and Clinical leaders and teams who are tasked with the development\, writing\, review or approval of performance evaluation reports for IVDR submissions. \n  \nWATCH NOW
URL:https://criterionedge.com/event/ivdr-in-focus-tips-for-performance-evaluation-planning-to-support-your-transition-from-ivdd-to-ivdr-2/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/May-22-2024.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20230628T110000
DTEND;TZID=America/Los_Angeles:20230628T120000
DTSTAMP:20230623T182051Z
CREATED:20230623T182051Z
LAST-MODIFIED:20230623T182051Z
UID:4840-1687950000-1687953600@criterionedge.com
SUMMARY:It’s All Interconnected: Hidden Traps That Can Derail Your PER
DESCRIPTION:With the implementation of IVDR requirements\, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. In this practical presentation\, Criterion Edge uncovers what we have learned from our experience in writing MDR-compliant CERs\, and how urgently applicable some of these key learnings are in preparing a robust Performance Evaluation Report (PER).   \nThis presentation provides practical tips on how to assess for hidden traps and unexpected roadblocks that could impact the success of writing an IVDR-compliant PER. By performing a gap analysis and assessing the readiness and availability of critical resources\, documents and expertise\, you will be able to avoid project delays and discover efficiencies that will enable the on-time completion of a successful\, IVDR-compliant PER.  \nLearning Objectives:  \n\nThe importance of scoping your PER project in advance  \nThe critical inputs needed to enable the success of your PER and the impact to the project if these inputs are not available or incomplete  \nHow to identify those hidden gaps in resources and information and the steps to take to mitigate them\n\nClick here to watch the webinar recording and download the presentation slides. \nWho is this webinar for? \nThose Regulatory\, Quality and Clinical leaders and teams who are tasked with the development\, writing\, review or approval of performance evaluation reports for IVDR submissions. \nAsk the Expert: Plain Language Written Content for Multiple Audiences: Effective Communication for Patients\, Caregivers\, and HCPs\nHealthcare companies continually strive to communicate important information about their drugs and devices to diverse audiences comprised of patients\, caregivers\, healthcare professionals (HCPs)\, and the general public. The use of plain language written content ensures key health information and clinical research findings are understandable and accessible to all. \nClick here to watch this recent webinar to learn key elements of plain language written content\, how to identify the target audience\, selecting the most appropriate dissemination channels for the information\, the challenges to produce a multitude of plain language written deliverables for multiple audiences\, and more.
URL:https://criterionedge.com/event/its-all-interconnected-hidden-traps-that-can-derail-your-per-3/
LOCATION:Webinar\, United States
CATEGORIES:MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/cover-with-date-Its-All-Interconnected-Hidden-Traps-that-can-Derail-your-PER-webinar-062823.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20230503T110000
DTEND;TZID=America/Los_Angeles:20230503T114500
DTSTAMP:20230413T205725Z
CREATED:20230413T205725Z
LAST-MODIFIED:20230413T205725Z
UID:4839-1683111600-1683114300@criterionedge.com
SUMMARY:Ask the Expert: Plain Language Written Content for Multiple Audiences: Effective Communication for Patients\, Caregivers\, and HCPs
DESCRIPTION:Healthcare companies continually strive to communicate important information about their drugs and devices to diverse audiences comprised of patients\, caregivers\, healthcare professionals (HCPs)\, and the general public. The use of plain language written content ensures key health information and clinical research findings are understandable and accessible to all. \nIf you or your team are producing a high volume of these written documents for multiple audiences\, join us for this 45-minute live Q&A. We will discuss some of the most common challenges and best practices that your organization can implement to support your goals this year. \nQuestions may cover the key elements of plain language written content\, how to identify the target audience\, selecting the most appropriate dissemination channels for the information\, the challenges to produce a multitude of plain language written deliverables for multiple audiences\, and more. \nDuring this session\, come prepared with your questions for our experts to answer. Please submit your questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. Also\, please note that answers will be limited to 3 minutes per question. This forum will answer questions on a first come first serve basis\, so please submit all your questions when you register for this event. \nClick here to watch the recording of this session. \nWho is this session for?\nThose Medical\, Clinical\, and Scientific Affairs leaders and teams who are develop write\, review or approve plain language written content or deliverables targeted to patients\, caregivers\, healthcare professionals (HCPs)\, and the general public. \nPlain Language Communication in Healthcare: Understanding the Requirements and Challenges of Plain Language Content Creation for Multiple Audiences\nMedical device manufacturers and pharma/biotech companies have a regulatory and legal obligation to convert key scientific content into plain language for lay audience consumption around the world. From producing clinical trial lay summaries for the general public to the action-focused informational content generation aimed at the Health Care Provider (HCP) audience\, the need to produce a multitude of plain language written deliverables has strained many already-stretched internal teams. How can your organization meet these challenges? \nWatch our recent webinar where we discuss the key aspects that define plain language writing​\, readability and suitability\, the regulatory and legal requirements of plain language content​\, and more.
URL:https://criterionedge.com/event/ask-the-expert-plain-language-written-content-for-multiple-audiences-effective-communication-for-patients-caregivers-and-hcps-3/
LOCATION:Virtual Q&A
CATEGORIES:MDR Webinars
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20230426T110000
DTEND;TZID=America/Los_Angeles:20230426T114500
DTSTAMP:20230412T211833Z
CREATED:20230412T211833Z
LAST-MODIFIED:20230412T211833Z
UID:4838-1682506800-1682509500@criterionedge.com
SUMMARY:Integration of Plain Language Content and Infographics into HCP Communication Channels: Strategies to Enhance HCP Engagement
DESCRIPTION:Healthcare companies continually strive to communicate important information about their drugs and devices to diverse audiences comprised of patients\, caregivers\, healthcare professionals (HCPs)\, and the general public. The use of plain language written communication can help ensure key health information and clinical research findings are understandable and accessible to all. \nBut you might wonder “Isn’t plain language intended only for patient and caregiver consumption? HCPs want factual\, scientifically rigorous content\, not the simplified messaging of plain language writing.” The answer is…. not always. The deliberate and targeted incorporation of plain language content into selected HCP communication channels can be an effective tool in in your omnichannel communication plan. \nClick here to watch the recording of this webinar. \nLearning Objectives:\nJoin us as we present information you can use to develop effective HCP-focused plain language content such as:\n1. Key elements of plain language content – what it is and what it isn’t\n2. How incorporation of plain language content into HCP-focused assets can create added value in HCP – patient interactions\n3. Common content formats that can be enhanced by the use of plain language content\n4. The elements of the Visual SRD and why HCPs prefer this format\n5. How innovative use of plain language \nWho is this webinar for?\nThose Medical\, Clinical\, and Scientific Affairs leaders and teams who are tasked with the development\, writing\, review or approval of plain language written content or deliverables targeted to healthcare professionals. \nAt the end of the presentation\, we will dedicate 15 minutes to answering your questions. Please submit your questions beforehand if you have any to help us prepare. Also\, you can submit your questions at any point during the presentation. \nClick here to watch the recording of this webinar. \n\nDeveloping Effective Patient-Focused Content: Writing Plain Language Lay Summaries and SSCP Patient Sections\n\nHealthcare companies continually strive to communicate important information about their drugs and devices to diverse audiences comprised of patients\, caregivers\, healthcare professionals (HCPs)\, and the general public. The use of plain language written communication can help ensure key health information and clinical research findings are understandable and accessible to all. \nIn the second presentation of our Deep-Dive: Plain Language Writing webinar series\, we will focus on best practices that guide the development of common forms of plain language communication intended for the patient\, their families and/or caregivers\, such as the:\n• Patient section of an EU MDR-compliant Summary of Safety and Clinical Performance (SSCP) for all Class III and Active Implantable Medical Devices (AIMD)\n• Plain Language Summary (PLS) of a published journal article\n• Lay summaries required under EU CTR for clinical trials on medicinal products \nWatch this recent webinar. \nLearning Objectives \nWatch this webinar to learn practical strategies you can use to develop effective patient-centered lay summary content such as: \nWho: Identify the target audience and the details and demographics of who they are.\nWhy: Why does the audience need to know the information?\nWhat: What are the goals of providing the content\, e.g.\, for information only\, to spur action\, or fulfill a regulatory requirement? What format is best suited to support the desired message and goal?\nHow: Identify the most appropriate dissemination channels for the information and any audience accessibility considerations.\nWhen: Determine any relevant timing strategies or requirements\, e.g.\, regulatory deadlines.
URL:https://criterionedge.com/event/integration-of-plain-language-content-and-infographics-into-hcp-communication-channels-strategies-to-enhance-hcp-engagement-3/
LOCATION:Webinar\, United States
CATEGORIES:MDR Webinars
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20230405T110000
DTEND;TZID=America/Los_Angeles:20230405T120000
DTSTAMP:20230309T222838Z
CREATED:20230309T222838Z
LAST-MODIFIED:20230309T222838Z
UID:4837-1680692400-1680696000@criterionedge.com
SUMMARY:Developing Effective Patient-Focused Content: Writing Plain Language Lay Summaries and SSCP Patient Sections
DESCRIPTION:Healthcare companies continually strive to communicate important information about their drugs and devices to diverse audiences comprised of patients\, caregivers\, healthcare professionals (HCPs)\, and the general public. The use of plain language written communication can help ensure key health information and clinical research findings are understandable and accessible to all. \nIn this second presentation of our Deep-Dive: Plain Language Writing webinar series\, we will focus on best practices that guide the development of common forms of plain language communication for patients\, their families and/or caregivers\, such as the: \n\nPatient section of an EU MDR-compliant Summary of Safety and Clinical Performance (SSCP) for all Class III and Active Implantable Medical Devices (AIMD)\nPlain Language Summary (PLS) of a published journal article\nLay summaries required under EU CTR for clinical trials on medicinal products\n\nClick here to watch the recording of this webinar. \nLearning Objectives:\nJoin us as we discuss practical strategies you can use to develop effective patient-centered lay summary content such as: \nWho: Identify the target audience and the details and demographics of who they are.\nWhy: Why does the audience need to know the information?\nWhat: What are the goals of providing the content\, e.g.\, for information only\, to spur action\, or fulfill a regulatory requirement? What format is best suited to support the desired message and goal?\nHow: Identify the most appropriate dissemination channels for the information and any audience accessibility considerations.\nWhen: Determine any relevant timing strategies or requirements\, e.g.\, regulatory deadlines. \nWho is this webinar for?\nThose Medical\, Clinical\, and Scientific Affairs leaders and teams who are tasked with the development\, writing\, review or approval of plain language written content or deliverables targeted to patients\, their families and/or caregivers. \nAt the end of the presentation\, we will dedicate 15 minutes to answering your questions. Please submit your questions beforehand if you have any to help us prepare. Also\, you can submit your questions at any point during the presentation. \nClick here to watch the recording of this webinar.  \nPlain Language Communication in Healthcare: Understanding the Requirements and Challenges of Plain Language Content Creation for Multiple Audiences\nHealthcare companies continually strive to communicate important information about their drugs and devices to diverse audiences comprised of patients\, caregivers\, healthcare professionals (HCPs)\, and the general public. The use of plain language written communication can help ensure key health information and clinical research findings are understandable and accessible to all.  ​ \nContent is the user experience.  Make your words count. \nWatch this recent webinar. \nKey Takeaways \n\nKey aspects that define plain language writing​\nPlain language content writing for multiple audiences​\nWhat is readability and suitability?​\nThe regulatory and legal requirements of plain language content​\nProject planning for publication of Plain Language Summaries
URL:https://criterionedge.com/event/developing-effective-patient-focused-content-writing-plain-language-lay-summaries-and-sscp-patient-sections-3/
LOCATION:Webinar\, United States
CATEGORIES:MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/patient-focused-content-040523.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20230315T110000
DTEND;TZID=America/Los_Angeles:20230315T120000
DTSTAMP:20230301T013115Z
CREATED:20230301T013115Z
LAST-MODIFIED:20230301T013115Z
UID:4836-1678878000-1678881600@criterionedge.com
SUMMARY:Critical Concepts Medical Device Software: Approaches to Determining Risk Classification\, Qualification\, and Safety and Performance Outcomes
DESCRIPTION:In case you are wondering if Medical Device Software (MDSW/SaMD) and digital health content is a hot topic\, the FDA released 4 guidance documents in 2022 alone\, on topics ranging from cyber security\, medical image devices\, and mobile medical applications. Furthermore\, the European MDR- EU 2017/745 and new IVDR – EU 2017/746 regulation contain stipulations related to how software is regulated\, classified\, and qualified. \nYou may be asking yourselves:\n– Is my software considered a medical device?\n– How do I address the clinical evaluation for my medical device software?\n– How do I define the safety and performance outcomes\, and other clinical evaluation parameters? \nJoin us for answers to these questions and to find out more about the topic of software as a medical device! \nWatch the recording of this webinar here. \nWho should register for this webinar?\n\n\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve clinical evaluation reports for MDR submissions.
URL:https://criterionedge.com/event/critical-concepts-medical-device-software-approaches-to-determining-risk-classification-qualification-and-safety-and-performance-outcomes-3/
LOCATION:Webinar\, United States
CATEGORIES:MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Critical-Concepts-SaMD-031523.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20230308T110000
DTEND;TZID=America/Los_Angeles:20230308T120000
DTSTAMP:20230228T221554Z
CREATED:20230228T221554Z
LAST-MODIFIED:20230228T221554Z
UID:4835-1678273200-1678276800@criterionedge.com
SUMMARY:Stay Focused: The Purpose of the SVR and Tips for Building a Strong PER Foundation
DESCRIPTION:The goal of performance evaluation is to show that your IVD performs as intended and meets the acceptance criteria\, therefore establishing that your IVD may be considered state of the art. Remember: the PER is a product\, but it is documenting a process. Performance evaluation can be straightforward if your analyte has a well-established association with a clinical condition. But what is the purpose of the SVR\, and how should you approach it when there is too much or not enough data? \nThis webinar will discuss the role of data sufficiency\, the importance of developing a solid strategy to establish scientific validity\, how gaps in the SVR can significantly impact the quality of the PER\, and how proper scoping can help maximize success when it comes to a performance evaluation. \nIn this webinar\, you will learn\n1. How to clearly define what information should (and shouldn’t) be presented within the Scientific Validity Report.\n2. How the systematic literature review process supports and connects the SVR\, CPR\, and APR by leveraging published data.\n3. How to conduct gap assessments to assess IVDR readiness and develop strategies to increase efficiencies in the performance evaluation process to support the SVR. \nAt the end of the presentation\, we will dedicate 15 minutes to answering your questions. Please submit your questions beforehand if you have any to help us prepare. Also\, you can submit your questions at any point during the presentation. \nWho should register for this webinar?\n\n\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve performance evaluation reports for IVDR submissions.\n\n\n\n\n\nClick here to watch the recording of this webinar. \nNew Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference\nIn October 2022\, the AAMI/FDA/BSI Annual Conference discussed current knowledge and practical strategies to meet new IVDR clinical evidence requirements. Dr. Sarah Chavez\, Criterion Edge Director of IVD Writing Services\, was invited to speak with other regulatory\, notified body and industry leaders as panelists at the pre-conference workshop “New Requirements for In Vitro Diagnostics”. \nWatch Dr. Chavez’s recent webinar and benefit from key insider insights gleaned from this meeting. Sarah shares and discusses the key take-aways from the Symposium\, including clinical evidence requirements and strategies to keep your report writing and data collection on track.  Many companies are in the early stages of planning for IVDR\, so take a step towards IVDR readiness with these helpful suggestions for planning and preparation from the perspective of experienced regulatory writers. \nWatch the webinar recording here.
URL:https://criterionedge.com/event/stay-focused-the-purpose-of-the-svr-and-tips-for-building-a-strong-per-foundation-3/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Stay-Focused-The-Purpose-of-the-SVR-03.08.23.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20230208T100000
DTEND;TZID=America/Los_Angeles:20230208T110000
DTSTAMP:20230222T164434Z
CREATED:20230203T004038Z
LAST-MODIFIED:20230222T164434Z
UID:4216-1675850400-1675854000@criterionedge.com
SUMMARY:Plain Language Communication in Healthcare Part 1 Webinar
DESCRIPTION:Plain Language Communication in Healthcare – Part 1: Understanding the Requirements and Challenges of Plain Language Content Creation for Multiple Audiences\nHealthcare companies such as medical device manufacturers and pharma/biotech companies have a regulatory and legal obligation to convert key scientific content into plain language for lay audience consumption around the world. From producing clinical trial lay summaries for the general public to the action-focused informational content generation aimed at the Health Care Provider (HCP) audience\, the need to produce a multitude of plain language written deliverables has strained many already-stretched internal teams. How can your organization meet these challenges? \nThis first presentation in a three-part Deep-Dive Plain Language series from Criterion Edge examines: \n• Key aspects that define plain language writing\n• The regulatory and legal requirements of plain language content\n• Plain language writing for multiple audiences\, e.g.\, lay audience versus Health Care Providers (HCPs)\n• Solutions to common pain points\, for example\, standardizing key messaging across multiple written deliverables and platforms \nAt the end of the presentation\, we will dedicate 15 minutes to answering your questions. Please submit your questions beforehand if you have any to help us prepare. Also\, you can submit your questions at any point during the presentation. \nClick here to watch the recording of this session.
URL:https://criterionedge.com/event/plain-language-communication-in-healthcare-part-1-webinar/
LOCATION:Webinar\, United States
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Plain-Language-Communication-in-Healthcare-part-1-webinar-020823.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20230201T110000
DTEND;TZID=America/Los_Angeles:20230201T120000
DTSTAMP:20230209T185651Z
CREATED:20230113T200731Z
LAST-MODIFIED:20230209T185651Z
UID:4105-1675249200-1675252800@criterionedge.com
SUMMARY:New Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference
DESCRIPTION:New Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference\nThe In Vitro Diagnostics Regulation (IVDR) took effect in May 2022 and has introduced substantial changes in the regulatory framework for in vitro diagnostic medical devices (IVDs) in Europe. IVD manufacturers are expected to meet more rigorous standards for clinical evidence\, with up to 80% of IVDs requiring Notified Body certificates under IVDR. \nIn October 2022\, the AAMI/FDA/BSI Annual Conference sought to discuss current knowledge and practical strategies to meet these new clinical evidence requirements. Dr. Sarah Chavez\, Criterion Edge Director of IVD Writing Services\, was honored to be an invited speaker. She joined with other regulatory\, notified body and industry leaders as panelists at the pre-conference workshop “New Requirements for In Vitro Diagnostics”. \nAttendees to this webinar will benefit from key insider insights gleaned from the Annual Conference\, as Sarah will be share and discuss the key take-aways from the Symposium\, including clinical evidence requirements and strategies to keep your report writing and data collection on track. Since most companies are in the early stages of planning for IVDR\, the goal of this webinar is to provide helpful suggestions for IVDR planning and preparation from the perspective of experienced regulatory writers. \nAt the end of the presentation\, we will dedicate 15 minutes to answering your questions. Please submit your questions beforehand if you have any to help us prepare. Also\, you can submit your questions at any point during the presentation. \nClick here to register for this session. \nWho should register for this webinar?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve performance evaluation reports for IVDR submissions\, or anyone looking to learn more about new requirements for in vitro diagnostics. \nKey Changes in the Regulatory Requirements for In Vitro Diagnostic Devices Marketed in the European Union Under IVDR 2017/746\nIn vitro diagnostic (IVD) medical devices in the European Union are being held to a higher standard of scrutiny with the introduction of In Vitro Diagnostic Regulation (IVDR) 2017/746 by the European Commission (EC). \nOverview of In Vitro Diagnostic Regulation 2017/746  \nThe implementation of IVDR dramatically changes the regulatory landscape for IVD medical devices. Some of the biggest changes include an expanded definition of IVDs\, a new classification of IVDs\, the requirement of Unique Device Identification (UDI) on each device\, an expansion of the Quality Management System\, and the increased need for Notified Body (NB) review. \nThe transition into IVDR is already underway. IVDs marketed in the EU will continue to require a CE Marking certificate to verify that the device meets all the regulatory requirements. Failure to meet the IVDR deadlines could be very costly to manufacturers that would either lose their CE Marking or fail to obtain one. Click here to read the full blog post that outlines the deadlines for manufacturers to become compliant with IVDR 2017/746.
URL:https://criterionedge.com/event/new-requirements-for-in-vitro-diagnostics-lessons-learned-from-the-aami-fda-bsi-annual-conference/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/New-Requirements-for-In-Vitro-Diagnostics-cover-020123.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20221102T110000
DTEND;TZID=America/Los_Angeles:20221102T120000
DTSTAMP:20221024T194146Z
CREATED:20221024T194146Z
LAST-MODIFIED:20221024T194146Z
UID:3938-1667386800-1667390400@criterionedge.com
SUMMARY:Critical Concepts: A Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies
DESCRIPTION:Critical Concepts: A Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies\nIn September 2022\, European Commissioners published updates to the Manual on Borderline and Classification for Medical Devices\, which provides clarifications for classifying devices as medical or in vitro diagnostic devices under the MDR and IVDR. This guidance describes how to distinguish medical devices from medicinal products\, biocides\, and personal protective equipment\, and how to distinguish between in vitro diagnostic medical devices and general laboratory equipment. \nThis “Critical Concepts” webinar will discuss rules for device classification under each regulation\, as well as the risk-based classification rules as described in MDCH 2021-24 and MDCG 2020-16. Our “Deep Dive” will provide insights into the potential impact of risk-based classifications on your data collection strategies to support data sufficiency in the CER and PER. \nThere will be time at the end of the presentation to get your questions answered. Please submit your questions beforehand if you have any to help us prepare. Also\, you can submit your questions at any point during the presentation. \nClick here to register for this session. \nWho should register for this webinar?\nThose Regulatory\, Quality and Clinical leaders and teams who are tasked with the development\, writing\, review\, or approval of clinical evaluation reports for MDR submissions or performance evaluation reports for IVDR submissions. Anyone interested in learning more about these requirements is welcome to attend. \nKey Changes in the Regulatory Requirements for In Vitro Diagnostic Devices Marketed in the European Union Under IVDR 2017/746\nIn vitro diagnostic (IVD) medical devices in the European Union are being held to a higher standard of scrutiny with the introduction of In Vitro Diagnostic Regulation (IVDR) 2017/746 by the European Commission (EC). \nOverview of In Vitro Diagnostic Regulation 2017/746  \nThe implementation of IVDR dramatically changes the regulatory landscape for IVD medical devices. Some of the biggest changes include an expanded definition of IVDs\, a new classification of IVDs\, the requirement of Unique Device Identification (UDI) on each device\, an expansion of the Quality Management System\, and the increased need for Notified Body (NB) review. \nThe transition into IVDR is already underway. IVDs marketed in the EU will continue to require a CE Marking certificate to verify that the device meets all the regulatory requirements. Failure to meet the IVDR deadlines could be very costly to manufacturers that would either lose their CE Marking or fail to obtain one. Click here to read the full blog post that outlines the deadlines for manufacturers to become compliant with IVDR 2017/746.
URL:https://criterionedge.com/event/critical-concepts-a-deep-dive-into-mdr-and-ivdr-device-classification-and-data-collection-strategies/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/cover-with-date-Critical-Concepts-Deep-Dive-into-MDR-and-IVDR-Device-Classification.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20221026T110000
DTEND;TZID=America/Los_Angeles:20221026T120000
DTSTAMP:20221027T213857Z
CREATED:20221006T233131Z
LAST-MODIFIED:20221027T213857Z
UID:3928-1666782000-1666785600@criterionedge.com
SUMMARY:Critical Concepts: The Role of Post Market Surveillance in Establishing Data Sufficiency
DESCRIPTION:Critical Concepts: The Role of Post Market Surveillance in Establishing Data Sufficiency\nIn this webinar\, we will review the conformity requirements for “legacy devices” under the MDR and “established devices” under the IVDR to help you harness the potential of effective post market activities. We will discuss how “legacy devices\,” defined as those previously certified under MDD/AIMDD\, can demonstrate conformity to the general safety and performance requirements under the MDR through a collection of pre-market and post-market data. \nAdditionally\, we will touch on some examples of the types of clinical data that are appropriate to use for “legacy devices” for both MDR and IVDR requirements\, and finally we will review the MDCG 2020-6 guidance on clinical data for “legacy devices.” \nThere will be time at the end of the presentation to get your questions answered. Please submit your questions beforehand if you have any to help us prepare. You can also submit your questions during the presentation. \nClick here to watch the recording of this session. \nWho should register for this webinar?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve clinical evaluation reports for MDR submissions\, or anyone interested in learning more about these requirements. Those from the IVD space are welcome to attend as this information may also be relevant. \nPost Market Surveillance: Systematic Literature Review and Case Study\nJoining Criterion Edge’s President Laurie Mitchell\, is guest speaker\, Queenita Fernandes\, Medtronic’s Medical Safety Manager\, Patient Monitoring & Respiratory Interventions​. In this webinar\, we discuss how to deploy systematic literature review in order to augment post market clinical surveillance\, and share best tips on a robust systematic literature review process. Following this\, our guest speaker shares an informative case study illustrating more. \nKey Takeaways: \n\nHow leveraging published data can help meet regulatory expectations and inform internal decision-making​\nSteps for conducting a methodologically-sound SLR​\nHow data obtained through SLR can empower the successful execution of post-market surveillance activities\, drive efficiencies and support regulatory compliance.\n\nWatch this free webinar here.
URL:https://criterionedge.com/event/critical-concepts-the-role-of-post-market-surveillance-in-establishing-data-sufficiency/
LOCATION:Webinar\, United States
CATEGORIES:MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Critical-Concepts-The-Role-of-Post-Market-Activities-in-Establishing-Data-Sufficiency-102622.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20221005T110000
DTEND;TZID=America/Los_Angeles:20221005T114500
DTSTAMP:20221006T215640Z
CREATED:20220921T184401Z
LAST-MODIFIED:20221006T215640Z
UID:3893-1664967600-1664970300@criterionedge.com
SUMMARY:Ask the Expert: Clinical Evaluation Report Critical Concepts
DESCRIPTION:Ask the Expert: Clinical Evaluation Report Template and Critical Concepts\nThis session is presented from the point of view of seasoned MDR-compliant CER medical writers. In this 45-minute live Q&A\, we will answer questions regarding critical concepts for a clinical evaluation report template such as safety and performance objectives\, clinical outcomes\, clinical benefits\, acceptance criteria\, and risk-benefit ratio. We hope to provide you with best practices and writing strategies to support solid planning during your own writing process. \nDuring this session\, come prepared with your questions for our experts to answer. Please submit your questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. Also\, please be aware that answers will be limited to 3 minutes per question. \nThis forum will answer questions on a first come first serve basis\, so please submit all your questions when you register for this event. \nClick here to watch the recording of this session. \nWho is this session for?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve clinical evaluation reports for MDR submissions or performance evaluation reports for IVDR submissions. \nHow to Deploy Systematic Literature Review in Order to Augment Post Market Clinical Surveillance\nAre you looking for best tips on how to create a robust systematic literature review process? And maybe even an informative case study illustrating the process? Watch our webinar on effective systematic literature review for post-market surveillance to understand how to continually support your device once your clinical evaluation report is completed and submitted. Learn how leveraging published data can help meet regulatory expectations and inform internal decision-making​\, the steps for conducting a methodologically-sound SLR​\, and even how data obtained through SLR can empower the successful execution of post-market surveillance activities\, drive efficiencies\, and support regulatory compliance. \nKey Strategies to Support Project Success: The Clinical Evaluation Report Template\nDo you know how to identify meaningful safety and performance endpoints (measures/objectives)? Are you confidently able to demonstrate that your safety and performance objectives are appropriate and clinically relevant? \nDownload our free white paper\, a companion piece to our popular webinar where we cover strategies to verify device safety and performance in the clinical evaluation of medical and in vitro diagnostic (IVDs) devices. This white paper should help you with identifying meaningful safety and performance measures for clinical or performance evaluation. It will also help with defining acceptance criteria parameters to determine the acceptability of benefit-risk as mandated by Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.
URL:https://criterionedge.com/event/ask-the-expert-clinical-evaluation-report-critical-concepts/
LOCATION:Virtual Q&A
CATEGORIES:MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/ATE-CER-Critical-Concepts-cover-100522.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220928T110000
DTEND;TZID=America/Los_Angeles:20220928T120000
DTSTAMP:20220929T213552Z
CREATED:20220916T221535Z
LAST-MODIFIED:20220929T213552Z
UID:3883-1664362800-1664366400@criterionedge.com
SUMMARY:CER Critical Concepts
DESCRIPTION:Clinical Evaluation Report Critical Concepts: Effectively Telling the Story of the CER – Focus on S&P Objectives\, Acceptance Criteria\, Clinical Benefits and Risk-Benefit Analysis\nSafety and performance objectives…..clinical outcomes…..clinical benefits…..acceptance criteria…..risk-benefit ratio. These terms represent key concepts of the Clinical Evaluation Report (CER)\, yet confusion still exists on how to effectively identify\, present and analyze these parameters within the context of an MDR-compliant CER. How do they tie together? How do they help you “tell the story” of the CER? \nClick here to watch the recording of this session. \nPresented from the point of view of seasoned MDR-compliant CER medical writers\, this session will take a practical approach to: \n\nDefine each of these concepts and their relationship to each other\nDevelop MDR-aligned safety and performance objectives\nHow clinical outcomes are leveraged in the CER and how they are different from S&P objectives\nTying it all together in the Risk-Benefit section of the CER (hint: this section is where it all comes together)\n\nThere will be time at the end of this session to ask questions. Please submit your questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. You may choose to send in your questions during the presentation as well. \nWho is this forum for?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve clinical evaluation reports for MDR submissions. Anyone interested in learning more about MDR requirements for CERs is also welcome to attend. Also\, we encourage professionals from the IVD industry to attend as well\, as the content is also relevant to IVDR requirements\, which align closely with MDR. \nCritical Concepts: Measurable Objectives and Acceptance Criteria\nThis white paper is a companion piece to our popular webinar where we cover strategies to verify device safety and performance in the clinical evaluation of medical and in vitro diagnostic (IVDs) devices. This white paper should help you with identifying meaningful safety and performance measures for clinical or performance evaluation and with defining acceptance criteria parameters to determine the acceptability of benefit-risk as mandated by Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746. \nEstablishing your device’s safety and performance is a critical component of the clinical evaluation process. However\, how to use the state of the art section within the Clinical Evaluation Report (CER) and Performance Evaluation Report (PER) to establish the device’s safety and performance objectives and acceptance criteria can seem ambiguous. \nDownload the full white paper here.
URL:https://criterionedge.com/event/cer-critical-concepts/
LOCATION:Webinar\, United States
CATEGORIES:MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/CER-Critical-Concepts-cover-090722.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220831T110000
DTEND;TZID=America/Los_Angeles:20220831T120000
DTSTAMP:20220903T163317Z
CREATED:20220903T163317Z
LAST-MODIFIED:20220903T163317Z
UID:3854-1661943600-1661947200@criterionedge.com
SUMMARY:Demonstration of Sufficient Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process
DESCRIPTION:Demonstration of Sufficient Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process \nIn the first part of our webinar series\, we discussed Legacy Devices\, WET devices\, and devices exempt from Clinical Investigations under Article 61\, along with the need for data sufficiency and how significant changes impact the route to conformity. In this webinar\, our medical regulatory experts\, Dr. Sarah Chavez and Stacie Beecham\, discuss the concept of data sufficiency and give you strategies for addressing limited clinical and performance data. We also discuss adjusting the Clinical Evaluation Plan to align with the regulatory strategy.  How do you determine which content applies to each classification? How do you address data insufficiency for a WET or Legacy device? We answer these questions and outline how to ensure your regulatory strategy will adequately support the clinical evaluation specific to your device. \nClick here to watch the recording of this webinar. \nWho should register for this webinar?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve clinical evaluation reports for MDR submissions\, or anyone interested in learning more about these requirements. Those from the IVD space are welcome to attend as this information may also be relevant. \nHow to Empower Data-Driven Decisions in Your Organization\nEvery day\, pharma and medical device companies need data from Systematic Literature Reviews (SLRs) to inform\, direct\, and help drive their internal processes and decisions. Of course\, to comply with global regulatory requirements\, clinical literature is also required. Conducting SLRs to search\, screen\, and extract data from published sources can present challenges to your team in terms of expertise (e.g.\, medical librarian)\, methodology\, and resources. It takes trained people with the availability to screen\, review\, and analyze the literature. \nDownload our free white paper\, Systematic Literature Review: How to Empower Data-Driven Decisions in Your Organization to read more on this topic. \nYou can also watch our webinar on this topic. \nOur President Laurie Mitchell joins Jennifer Tetzlaff\, Research Product Specialist with Evidence Partners\, to talk to you about the following points: \n\nExamples of how the use of published data can support regulatory expectations\nWhen to conduct a systematic literature review\nBest practices for conducting a methodologically-sound SLR\nUse of available tools and technology
URL:https://criterionedge.com/event/demonstration-of-sufficient-evidence-and-regulatory-strategy-alignment-in-the-clinical-evaluation-process/
LOCATION:Webinar\, United States
CATEGORIES:MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/cover-without-date-Demonstration-of-Sufficient-Evidence-1.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220803T110000
DTEND;TZID=America/Los_Angeles:20220803T120000
DTSTAMP:20220902T191940Z
CREATED:20220728T224501Z
LAST-MODIFIED:20220902T191940Z
UID:3777-1659524400-1659528000@criterionedge.com
SUMMARY:Bridging the Gaps: Clinical Data for GSPRs
DESCRIPTION:Bridging the Gaps: Determining Clinical Data Sufficiency to Demonstrate Conformity with GSPRs\nWhat do I do if there is no data for my device? This is a concern we hear quite often from clients. MDR states that device groups may not require clinical investigations if sufficient clinical evidence exists and the device meets specific criteria. In this webinar\, we will discuss the concept of clinical data sufficiency. Specifically\, we will explain the differences between a well-established technology and a legacy device as defined by MDR\, and discuss strategies from both a regulatory and writer’s perspective. \nClick here to watch the recording of this webinar. \nThere will be time at the end of the webinar to get your questions answered. Please submit any questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. You may also send in your questions during the webinar. \nWho should register for this webinar?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve clinical evaluation reports for MDR submissions\, or anyone interested in learning more about these requirements. Those from the IVD space are welcome to attend as this information may also be relevant. \nHow to Empower Data-Driven Decisions in Your Organization\nEvery day\, pharma and medical device companies need data from Systematic Literature Reviews (SLRs) to inform\, direct\, and help drive their internal processes and decisions. Of course\, to comply with global regulatory requirements\, clinical literature is also required. Conducting SLRs to search\, screen\, and extract data from published sources can present challenges to your team in terms of expertise (e.g.\, medical librarian)\, methodology\, and resources. It takes trained people with the availability to screen\, review\, and analyze the literature. \nDownload our free white paper\, Systematic Literature Review: How to Empower Data-Driven Decisions in Your Organization to read more on this topic. \nYou can also watch our webinar on this topic. \nOur President Laurie Mitchell joins Jennifer Tetzlaff\, Research Product Specialist with Evidence Partners\, to talk to you about the following points: \n\nExamples of how the use of published data can support regulatory expectations\nWhen to conduct a systematic literature review\nBest practices for conducting a methodologically-sound SLR\nUse of available tools and technology
URL:https://criterionedge.com/event/bridging-the-gaps-clinical-data-for-gsprs/
LOCATION:Webinar\, United States
CATEGORIES:MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/bridging-the-gaps-clinical-data-for-GSPRs-webinar-cover-080322.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220713T110000
DTEND;TZID=America/Los_Angeles:20220713T114500
DTSTAMP:20220722T200430Z
CREATED:20220627T202106Z
LAST-MODIFIED:20220722T200430Z
UID:3739-1657710000-1657712700@criterionedge.com
SUMMARY:ATE: The Role of RA in the Clinical and Performance Evaluation Process
DESCRIPTION:Ask the Expert: The Role of Regulatory Affairs in the Clinical and Performance Evaluation Process\nRegulatory Affairs is poised to play a critical role in supporting the current MDR and IVDR required clinical and performance evaluation process\, from project implementation through report writing and finally\, the on-time submission to the notified body. In this session\, we answer questions from many stages of the writing process\, from the early planning stage through completion of all required written deliverables. Topics include early assessment of data sufficiency\, equivalence considerations\, internal readiness of critical documentation\, project planning strategies\, or how to identify potential roadblocks and proactively find solutions to common problems. \nClick here to watch the recording of this session. \nWho should watch this session?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve clinical evaluation reports for MDR submissions or performance evaluation reports for IVDR submissions. \nThinking about using an outsourced regulatory writing team\, but aren’t sure of the advantages?\nIn today’s medical device and pharmaceutical environment\, it’s imperative to analyze and present complex information clearly and concisely while meeting critical timelines. Partnering with team of experienced regulatory writers can be a beneficial alternative to maintaining an in-house writing staff. \nRead our blog post to help decide if outsourcing is the right decision for your team. \nKey Strategies to Support Project Success for the Clinical and Performance Evaluation Process\nDo you know how to identify meaningful safety and performance endpoints (measures/objectives)? Are you confidently able to demonstrate that your safety and performance objectives are appropriate and clinically relevant? \nDownload our free white paper\, a companion piece to our popular webinar where we cover strategies to verify device safety and performance in the clinical evaluation of medical and in vitro diagnostic (IVDs) devices. This white paper should help you with identifying meaningful safety and performance measures for clinical or performance evaluation. It will also help with defining acceptance criteria parameters to determine the acceptability of benefit-risk as mandated by Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.
URL:https://criterionedge.com/event/the-role-of-ra-in-the-clinical-and-performance-evaluation-process/
LOCATION:Virtual Q&A
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/ATE-The-role-of-RA-cover-071322.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20220620
DTEND;VALUE=DATE:20220625
DTSTAMP:20220524T235048Z
CREATED:20220331T215612Z
LAST-MODIFIED:20220524T235048Z
UID:3484-1655683200-1656115199@criterionedge.com
SUMMARY:Medtech Summit
DESCRIPTION:Join us at Medtech Summit in Dublin\, Ireland\nCriterion Edge provides medical and regulatory writing services for the medical device industry and will be attending Medtech Summit in Dublin\, Ireland\, from June 20-24. Our specialists will be on site at the convention ready to meet you and your team to discuss your writing or project needs. \nWe’re excited to be sponsoring MedTech Summit 2022! Join us and get 10% off* your pass with our discount code MTCH22SPO. You can register here if you haven’t already. The summit is hybrid\, so if you’d like to be a part of the digital experience only\, you can sign up for the digital pass. Explore the full 2022 MedTech Summit agenda here. \nCriterion Edge supports medical device companies like the ones attending with the production of the required MDR submissions. These include\, but are not limited to\, clinical evaluations reports (CER) and plans (CEP)\, clinical performance reports (CPR)\, post-market clinical follow-up (PMCF) plans and reports\, post-market surveillance (PMS) reports\, PSURs and summary of safety and clinical performance (SSCP)\, and systematic literature reviews. Read more about us here. \nIf you’re attending\, let’s schedule time to meet in person at the event. If you can’t make it to the conference\, we’d still like to meet and chat with you and/or a colleague at a time that works for you. Book a convenient time to speak with us here.
URL:https://criterionedge.com/event/medtech-summit-june-20-24-dublin/
LOCATION:Clayton Hotel Burlington Road\, Leeson Street Upper\, Dublin\, D04 A318\, Ireland
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/medtech-summit-sponsor-social-media-banner.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220615T110000
DTEND;TZID=America/Los_Angeles:20220615T120000
DTSTAMP:20220616T005819Z
CREATED:20220602T195713Z
LAST-MODIFIED:20220616T005819Z
UID:3622-1655290800-1655294400@criterionedge.com
SUMMARY:The Role of RA in the Clinical and Performance Evaluation Process
DESCRIPTION:The Role of Regulatory Affairs in the Clinical and Performance Evaluation Process: Key Strategies to Support Project Success\nRegulatory Affairs plays a critical role in supporting the current MDR and IVDR required clinical/performance evaluation process\, from project implementation through report writing and finally\, the on-time submission to the notified body. From the early planning stage through completion of all required written deliverables\, this presentation examines key drivers of project success\, such as early assessment of data sufficiency\, equivalence considerations\, internal readiness of critical documentation\, project planning strategies\, and how to identify potential roadblocks and proactively find solutions to common problems. \nClick here to watch the recording of this webinar. \nKey Takeaways:\n1. Identify critical components of the clinical evaluation process and strategies to support project success. \n2. Describe how Regulatory Affairs can support cross-functional stakeholders and lead critical decision-making throughout the clinical evaluation process. \n3. Recognize and implement early mitigation strategies to overcome roadblocks and drive to on-time submission. \nThere will be time at the end of the presentation to get your questions answered. Please submit your questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. Also\, answers will be limited to 3 minutes per question. \nWho should register for this webinar?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve clinical evaluation reports for MDR submissions or performance evaluation reports for IVDR submissions. \nThinking about using an outsourced regulatory writing team\, but aren’t sure of the advantages?\nIn today’s medical device and pharmaceutical environment\, it’s imperative to analyze and present complex information clearly and concisely while meeting critical timelines. Partnering with team of experienced regulatory writers can be a beneficial alternative to maintaining an in-house writing staff. \nRead our blog post to help decide if outsourcing is the right decision for your team. \nKey Strategies to Support Project Success for the Clinical and Performance Evaluation Process\nDo you know how to identify meaningful safety and performance endpoints (measures/objectives)? Are you confidently able to demonstrate that your safety and performance objectives are appropriate and clinically relevant? \nDownload our free white paper\, a companion piece to our popular webinar where we cover strategies to verify device safety and performance in the clinical evaluation of medical and in vitro diagnostic (IVDs) devices. This white paper should help you with identifying meaningful safety and performance measures for clinical or performance evaluation. It will also help with defining acceptance criteria parameters to determine the acceptability of benefit-risk as mandated by Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.
URL:https://criterionedge.com/event/strategies-to-support-project-success-in-the-clinical-and-performance-evaluation-process/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/the-role-of-RA-webinar-cover-061522.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220601T110000
DTEND;TZID=America/Los_Angeles:20220601T120000
DTSTAMP:20220602T200132Z
CREATED:20220512T170649Z
LAST-MODIFIED:20220602T200132Z
UID:3576-1654081200-1654084800@criterionedge.com
SUMMARY:Scoping Your MDR & IVDR Writing Projects
DESCRIPTION:Scoping Your MDR and IVDR Writing Projects – The Forgotten Step\nIn most of our webinars\, we’ve focused on the writing process including which steps to take and how to organize your thoughts onto paper. However\, we’ve never discussed what happens before the writing process begins. So what do you need before you get started? \nIn this webinar\, we’ll discuss the process of scoping a writing project for either MDR or IVDR. We will share the key questions we ask our clients before we start writing and what key inputs are necessary to kickstart the project and ensure you’re starting on the right foot. \nWe hope to \n\nGive insight into planning realistic timelines and assessing your team’s bandwidth to complete your project\nProvide examples of key documents and inputs needed early in the writing process\nDescribe where these pieces fit within the Clinical Evaluation Report or Performance Evaluation Report templates\n\nWho is this forum for?\nThose regulatory\, quality and clinical leaders and teams who are tasked with the development\, writing\, review\, or approval of Clinical Evaluation Reports for MDR submissions or Performance Evaluation Reports for IVDR submissions. Anyone interested in learning more about the requirements for these reports is also welcome to attend. \nClick here to watch the recording of this webinar. \n6 Project Management Secrets Used by Top Medical Writers\nI bet when you became a medical writer\, you didn’t imagine most of your time would be spent on managerial tasks that don’t involve writing at all. According to one prominent medical writing consultant\, most medical writers spend 60% of their time on writing and 40% on project management. As you have likely discovered\, the skills required of today’s medical writers go beyond subject matter and regulatory expertise. Given the size and scope of most medical writing projects\, this is no surprise. If you find yourself overwhelmed by the project management oversight needed for large projects and overlapping projects involving multiple writers\, you’re not alone. \nClick here to read these six key tactics to ensure your next medical writing job runs smoothly and meets the necessary requirements. \nAt Criterion Edge\, our clients enjoy our transparency in the services we provide as our candid scoping includes a time frame for delivering the CER and detailed information on gaps in compliance. All of our writers have experience writing CERs and are up to date on current regulations. Providing a comprehensive analysis and subsequent solutions sets us apart from other vendors. Contact us if you would like to have a conversation about what we can do to help with your writing and regulatory needs. 
URL:https://criterionedge.com/event/scoping-your-mdr-ivdr-writing-projects/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Scoping-Your-MDR-and-IVDR-Projects-060122.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220518T110000
DTEND;TZID=America/Los_Angeles:20220518T114500
DTSTAMP:20220520T174735Z
CREATED:20220428T050347Z
LAST-MODIFIED:20220520T174735Z
UID:3535-1652871600-1652874300@criterionedge.com
SUMMARY:Ask the Writers
DESCRIPTION:Ask the Writers: A Comparison of Critical Elements of the Scientific Validity Report vs. the CER State-of-the-Art and Best Practice Writing Strategies\nIn this highly interactive question-and-answer session\, Criterion Edge experts Laurie Mitchell\, President\, and Dr. Sarah Chavez\, Director of IVD and Scientific Writing Services\, will outline the must-have elements for two very similar regulatory reports: the State-of-the-Art section of an EU MDR-compliant Clinical Evaluation Report (CER) and the EU IVDR Scientific Validity Report (SVR). \nParticipants will understand the required and critical content that is common to both documents and learn best-practice writing strategies to support successful completion of these challenging projects. Come with your questions ready to get feedback from our experts! \nPlease submit your questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. Also\, please be aware that answers will be limited to 3 minutes per question. \nThis forum will answer questions on a first come first serve basis\, so please submit all your questions when you register for this event. \nWho is this forum for?\nThose regulatory\, quality and clinical leaders and teams who are tasked with the development\, writing\, review\, or approval of Clinical Evaluation Reports for MDR submissions or Scientific Validity Reports for IVDR submissions. Anyone interested in learning more about the requirements for these reports is also welcome to attend. \nClick here to watch the recording of this session. \nWhy is it important to establish state of the art during the clinical evaluation?\nThe large number of mentions of state of the art throughout MEDDEV 2.7/1 rev 4 provide not only a comprehensive description of the importance\, purpose\, and role of establishing the state of the art\, but also inform on how to incorporate this analysis into the clinical evaluation. The image below summarizes several core roles of this analysis. \nEstablishing and describing state of the art is not an isolated task\, but is central to the entire clinical evaluation. Defining the current\, accepted best treatment options\, and describing the risks and benefits of these options\, provides essential information for multiple aspects of the clinical evaluation. Thus\, establishing state of the art yields information that is essential for determining if the safety and performance of a device is compatible with current standards (in comparison to available treatment options). In other words\, state of the art establishes a reference standard that is used throughout the clinical evaluation. \nIf you want to find out more about State of the Art according in MEDDEV 2.7/1 rev 4\, you can download our full whitepaper.
URL:https://criterionedge.com/event/ask-the-writers-critical-elements-of-the-scientific-validity-report/
LOCATION:Virtual Q&A
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Ask-the-Writers-SVR-and-CER-webinar-cover-051822.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20220510
DTEND;VALUE=DATE:20220513
DTSTAMP:20220511T214917Z
CREATED:20220511T214917Z
LAST-MODIFIED:20220511T214917Z
UID:3572-1652140800-1652399999@criterionedge.com
SUMMARY:RAPS Euro Convergence
DESCRIPTION:Join us at RAPS Euro Convergence in Amsterdam\, Netherlands\nCriterion Edge provides medical and regulatory writing services for the medical device\, pharmaceutical\, and in vitro diagnostics industries and will be attending RAPS Euro Convergence in Amsterdam\, from May 10-12. Our specialists will be on site at the conference ready to meet you and your team to discuss your writing or project needs. Stop by our booth for a chance to win a cool travel accessory each day. \nYou can register here if you haven’t already. Explore the full 2022 convergence agenda here. \nCriterion Edge supports medical device companies like the ones attending with the production of the required MDR submissions. These include\, but are not limited to\, clinical evaluations reports (CER) and plans (CEP)\, clinical performance reports (CPR)\, post-market clinical follow-up (PMCF) plans and reports\, post-market surveillance (PMS) reports\, PSURs and summary of safety and clinical performance (SSCP)\, and systematic literature reviews. Read more about us here. \nIf you’re attending\, let’s schedule time to meet in person at the event. If you can’t make it to the conference\, we’d still like to meet and chat with you and/or a colleague at a time that works for you. Book a convenient time to speak with us here.
URL:https://criterionedge.com/event/raps-euro-convergence-2022/
LOCATION:Park Inn by Radisson Amsterdam City West\, Netherlands
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220428T110000
DTEND;TZID=America/Los_Angeles:20220428T114500
DTSTAMP:20220520T174942Z
CREATED:20220324T235600Z
LAST-MODIFIED:20220520T174942Z
UID:3442-1651143600-1651146300@criterionedge.com
SUMMARY:[Ask the Expert] Common Notified Body Review Findings
DESCRIPTION:This session’s topic: Tips For How to Avoid Common Notified Body Review Findings\nCriterion Edge is often approached by clients with MDR Clinical Evaluation Reports (CERs) that require extensive revisions based upon Notified Body review and feedback.  Addressing NB feedback costs your team time and effort and may threaten critical submission deadlines. However many of these issues might have been avoidable with thorough pre-planning\, proper project scoping and asking the right questions from the beginning.  In this “Ask the Expert” question-and-answer session\, we will show you some of the most common issues our writing team encounters with clients who face these revisions and discuss how they can be avoided. Presented from the perspective of experienced medical writers\, we hope to provide examples of how solid planning during your own writing process can help you avoid the most common missteps in your own CER or PER. \nDuring this 45-minute session\, come prepared with your questions for our experts to answer regarding your notified body review findings. Please submit them ahead of time while registering so we have ample time to answer them thoughtfully. Also\, please be aware that answers will be limited to 3 minutes per question. \nThis forum will answer questions on a first come first serve basis\, so please submit all your questions when you register for this event. \nWho is this forum for?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve clinical evaluation reports for MDR submissions or performance evaluation reports for IVDR submissions. \nClick here to watch the recording of this session. \n“Unachievable Deadlines” – The EU’s Team-NB Calls for New Guidance on Allowing Remote Audits\nNotified Bodies (NBs) across Europe along with global manufacturers are facing resource constraints. The cause? Additional requirements imposed by the new MDR/IVDR Regulations. Team-NB\, the European notified body association\, issued a position paper to express concerns about lack of resources and guidance to assist in meeting the certification deadlines. \nThe primary concern cited is the likely device shortage for patients. More complex and longer certification processes required under MDR/IVDR are influencing this shortage. In conjunction\, the demands are too great for the small number of MDR/IVDR designated Notified Bodies (NBs). With only 25 NBs for MDR and 6 for IVDR\, the demand outweighs supply. Compared with 51 NBs designated for MDD and 21 under the AIMDD/IVDD Directives\, manufacturers are in a tough situation now compared to years prior. \nTeam-NB identified the following four primary contributing factors\, summarized in our recent blog post here.
URL:https://criterionedge.com/event/ask-the-expert-tips-to-avoid-common-notified-body-review-findings/
LOCATION:Virtual Q&A
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/ATE-Notified-Body-review-findings-cover-042822.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220423T080000
DTEND;TZID=America/Los_Angeles:20220426T170000
DTSTAMP:20220331T215853Z
CREATED:20220331T215853Z
LAST-MODIFIED:20220331T215853Z
UID:3458-1650700800-1650992400@criterionedge.com
SUMMARY:Annual European Congress of Clinical Microbiology & Infectious Diseases
DESCRIPTION:Join us at the ECCMID in Lisbon\, Portugal\nCriterion Edge provides medical and regulatory writing services for the in vitro diagnostics (IVD) industry and will be attending the 32nd European Congress of Clinical Microbiology & Infectious Diseases in Lisbon\, Portugal\, from April 23-26\, 2022. President\, Laurie Mitchell\, will be on site at the convention ready to meet you and your team. \nYou can register here if you haven’t already. \nCriterion Edge supports in-vitro diagnostic device companies like the ones attending with the production of the required IVDR submissions. These include\, but are not limited to\, performance evaluations report (PER)\, scientific validity report (SVR)\, clinical performance report (CPR)\, performance evaluation plan (PEP)\, and systematic literature reviews. Read more about us here. \nIf you’re attending\, let’s schedule time to meet in person at the event. Can’t make it to the conference? We’d still like to meet and have a chat with you and/or a colleague at a time that works for you. Book a convenient time to speak with us here.
URL:https://criterionedge.com/event/annual-european-congress-of-clinical-microbiology-infectious-diseases/
LOCATION:FIL – FEIRA INTERNACIONAL DE LISBOA\, Edificio FIL\, Rua do Bojador\, Parque das Nações\, Lisbon\, 1998-010\, Portugal
ORGANIZER;CN="ESCMID":MAILTO:eccmidregistration[@escmid.org
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220420T110000
DTEND;TZID=America/Los_Angeles:20220420T120000
DTSTAMP:20220520T175031Z
CREATED:20220301T235059Z
LAST-MODIFIED:20220520T175031Z
UID:3375-1650452400-1650456000@criterionedge.com
SUMMARY:How to Establish the Competitive Landscape Within the Scientific Validity Report
DESCRIPTION:In this practical presentation\, Dr. Sarah Chavez\, will present a detailed outline of the IVDR State of the Art search within the Performance Evaluation Report (PER). Additionally\, she will distinguish between the purpose and scope of the state-of-the-art and the Competitor search. For example\, the SLR approach\, data screening\, and data presentation will be addressed. \nYou will learn:\n\nThe importance of the SOA SLR for providing background and general information\nHow to establish acceptance criteria with data\nHow to assess the safety and performance of your IVD with a systematic approach to the Competitor SLR process\n\nWho should attend?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review or approve Performance Evaluation Reports for EU IVDR submission. Also\, anyone interested in learning more about the competitive landscape within the Scientific Validity Report should attend. \nClick here to watch the webinar recording. \nIVDR Essentials: Performance Evaluation Report – Early Planning and Preparation\nHow can scoping help you identify critical internal documents needed for IVDR readiness? What are the benefits to beginning the process early? There are many moving pieces needed to write a PER\, so we have developed strategies to keep you and your team on track and help assess your own level of preparedness. Using our CE Scoping checklist\, we will walk through the necessary documents\, SOPs\, processes\, reports\, and templates\, and explain how each of these fits into the overall process of preparing to write. \nThis presentation will emphasize the importance of scoping\, discuss how to develop a checklist\, and illustrate how scoping may help you identify gaps or missing pieces that could lead to delays or challenges in your PER writing process. \nWatch the free webinar recording now.
URL:https://criterionedge.com/event/how-to-establish-the-competitive-landscape-within-the-scientific-validity-report-2/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/establish-the-competitive-landscape-cover-slide-042022.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20220330T110000
DTEND;TZID=America/Los_Angeles:20220330T120000
DTSTAMP:20220330T223102Z
CREATED:20220216T200837Z
LAST-MODIFIED:20220330T223102Z
UID:3339-1648638000-1648641600@criterionedge.com
SUMMARY:IVD Deep Dive Series Part 2
DESCRIPTION:Clinical Data Sources: Leveraging Clinical Data in the Clinical Performance Report\nIn Part 1 of our IVD Deep Dive series\, we discussed the importance of selecting meaningful performance objectives and explained how these objectives help establish the acceptance criteria. Part 2 of our series will pick up from there with strategies to identify sources of clinical data for your IVD. \nPresented from the point of view of seasoned MDR-compliant CER medical writers\, this session will present strategies for the verification of IVD clinical performance in the PER. This presentation should help you identify meaningful and measurable performance measures and identify sources of clinical data to support the Clinical Performance Report (CPR). \nKey Takeaways: \n\nDiscuss the purpose of the CPR and its role as a critical component of the PER\nIdentify sources of clinical data and analyze those data within the context of the\nperformance endpoints and acceptance criteria presented in the SVR\nDemonstrate how to extract\, organize\, and appraise these data within the CPR\n\nWatch the webinar recording. \nWho should watch this webinar?\nThose Regulatory\, Quality and Clinical leaders and teams who develop\, write\, review\, or approve clinical performance reports for IVDR submissions. \n  \nKey Changes in the Regulatory Requirements for In Vitro Diagnostic Devices Marketed in the European Union Under IVDR 2017/746\nIn vitro diagnostic (IVD) medical devices in the European Union are being held to a higher standard of scrutiny with the introduction of In Vitro Diagnostic Regulation (IVDR) 2017/746 by the European Commission (EC). \nOverview of In Vitro Diagnostic Regulation 2017/746 \nThe implementation of IVDR dramatically changes the regulatory landscape for IVD medical devices. Some of the biggest changes include an expanded definition of IVDs and a new classification of IVDs. Some other changes are the requirement of Unique Device Identification (UDI) on each device\, an expansion of the Quality Management System\, and the increased need for Notified Body (NB) review. \nThe transition into IVDR is already underway. Consequently\, IVDs marketed in the EU will continue to require a CE Marking certificate. This is necessary to verify that the device meets all the regulatory requirements. Indeed\, failure to meet the IVDR deadlines could be very costly to manufacturers. They would either lose their CE Marking or fail to obtain one. \nRead more on this topic in our blog post\, here.
URL:https://criterionedge.com/event/ivd-deep-dive-series-part-2-clinical-data-sources/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/IVD-Deep-Dive-series-part-2-cover-033022.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
END:VCALENDAR