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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: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: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: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: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:20240828T120000
DTEND;TZID=America/Chicago:20240828T124500
DTSTAMP:20240904T173823Z
CREATED:20240813T214236Z
LAST-MODIFIED:20240904T173823Z
UID:6301-1724846400-1724849100@criterionedge.com
SUMMARY:Ask the Expert: The Role of Real-World Evidence (RWE) in Regulatory Submissions
DESCRIPTION:Welcome to our Ask The Expert series\, where the Criterion Edge team of experts take your questions on trending industry topics relevant to the work you do every day.  From global regulatory challenges\, clinical evidence issues or regulatory writing best practices\, the goal of this Q&A format is to share information\, ideas and solutions. \nToday’s conversation tackles the rapidly evolving landscape of Real World Evidence and its potential use in global regulatory submissions\, as we discussed in our July 31st Pharma In Focus: The Role of Real World Evidence in Regulatory Submissions webinar. \nBring your questions and join the conversation! \n  \nWATCH WEBINAR
URL:https://criterionedge.com/event/ask-the-expert-the-role-of-real-world-evidence-rwe-in-regulatory-submissions/
LOCATION:Webinar\, United States
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Webinar-8_28_2024-dr-Sheila-Grab-v4.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20240925T120000
DTEND;TZID=America/Chicago:20240925T130000
DTSTAMP:20240927T211511Z
CREATED:20240904T195155Z
LAST-MODIFIED:20240927T211511Z
UID:6520-1727265600-1727269200@criterionedge.com
SUMMARY:Good Science vs. Bad Writing: Strategies for Building an Effective Scientific Writing Team
DESCRIPTION:Writing is not an innate talent\, but a learned skill requiring extensive training and practice. Scientific writing is no exception.  As scientists\, we have all seen examples of how bad writing and ineffective communication can detract from good science. The goal of this presentation is to describe strategies to support effective partnerships between regulatory experts and your writing team. \nIn this presentation\, we will discuss what it takes to produce a document that is clear\, concise\, and complete\, meeting basic regulatory requirements but also effectively telling the story of your device.  We will also present strategies to help you assess your current writing processes and offer tips for document preparation to support effective writing partnerships within your organization. And finally\, we will describe recent themes and feedback regarding medical device and in vitro device evaluation reports\, as well as ways to proactively design solutions to common concerns including time\, budget\, bandwidth\, and internal resources. \nDuring this presentation\, we will… \n\nDiscuss how to plan a realistic timeline for your project.\nProvide advice for assessing your team’s bandwidth and scientific writing expertise.\nPresent examples of key documents and inputs needed early in the writing process.\nDescribe how Regulatory Affairs can support critical decision-making throughout the planning and preparation of these key reports.\nProvide practical strategies to support successful completion of these writing projects with an outside writing partner.\n\n\nWATCH NOW
URL:https://criterionedge.com/event/good-science-vs-bad-writing-strategies-for-building-an-effective-scientific-writing-team/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Webinar-Cover-25-Sep-2024-v4.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20241113T120000
DTEND;TZID=America/Chicago:20241113T130000
DTSTAMP:20241114T185315Z
CREATED:20241022T151807Z
LAST-MODIFIED:20241114T185315Z
UID:6557-1731499200-1731502800@criterionedge.com
SUMMARY:Devices in Focus: How to Save Time & Money with Real World Evidence (RWE)
DESCRIPTION:Real world evidence is increasingly important for companies seeking to demonstrate device performance without the time and expense of extensive clinical trials. This webinar will explore how to effectively use real-world evidence in regulatory submissions to accelerate product approvals and meet post-market surveillance requirements. \nLearning Objectives: \n\nSummarize recent regulatory guidance pertaining to the use of RWE in regulatory submissions.\nDiscuss why RWE is valuable for your regulatory strategies from both a cost and time savings perspective.\nExplain potential challenges (and solutions) when using RWE to support safety and performance of your device.\nIdentify strategies for integrating RWE into regulatory submissions using case studies and recent examples encountered by our Criterion Edge team.\n\nWho is this for: \n\nRegulatory Affairs\nChief Medical Officers\nMedical & Scientific Writers\n\n  \nWATCH NOW
URL:https://criterionedge.com/event/devices-in-focus-how-to-save-time-money-with-real-world-evidence-rwe/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Nov-14th-2024-Sarah-Chavez.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20241211T120000
DTEND;TZID=America/Chicago:20241211T130000
DTSTAMP:20241205T224448Z
CREATED:20241108T165200Z
LAST-MODIFIED:20241205T224448Z
UID:6581-1733918400-1733922000@criterionedge.com
SUMMARY:Overcoming Deadline Bottlenecks in Pharma: How a Writing Team Can Help
DESCRIPTION:Overview\nIn the fast-paced environment of pharmaceutical development\, project demands often outstrip available resources\, leading to critical bottlenecks in deliverables. Teams frequently find themselves finishing one clinical study and needing to pivot to the next project development\, leaving tasks like CSR completion sidelined. Additionally\, competing priorities\, from regulatory requirements to study design revisions\, can push essential writing deliverables to the back burner. By leveraging the skills and expertise of an experienced writing team\, companies can ensure the timely completion of documents and maintain project momentum without compromising quality.  \nLearning Objectives \n\nExplore common bottlenecks in pharmaceutical documentation workflows and their impact.\nUnderstand the added value of external medical writing teams to alleviate internal resource constraints and improve efficiency.\nLearn strategies for integrating external writing and project management support into ongoing projects to ensure timely completion of critical documents like CSRs\, IBs\, and protocols. \n\n  \nRESERVE YOUR SPOT\n 
URL:https://criterionedge.com/event/overcoming-deadline-bottlenecks-in-pharma-how-a-writing-team-can-help/
LOCATION:Webinar\, United States
CATEGORIES:Pharma Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Wednesday-11th-2024-v2.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250129T120000
DTEND;TZID=America/Chicago:20250129T130000
DTSTAMP:20250116T160305Z
CREATED:20250109T213710Z
LAST-MODIFIED:20250116T160305Z
UID:6632-1738152000-1738155600@criterionedge.com
SUMMARY:FDA Pre-Determined Change Control Plan (PCCP): Recommendations for Planning Your Strategy and Approach
DESCRIPTION:Overview\nUnderstand the intricacies of the FDA’s Pre-Determined Change Control Plan (PCCP) and its application across medical devices and in vitro diagnostics (IVDs). This webinar is designed for global regulatory and quality professionals aiming to streamline their strategies for managing post-market device modifications. Attendees will walk away with a deeper understanding of regulatory changes and actionable steps to support compliance objectives and improve efficiency in submissions. \nLearning Objectives:\n\nUnderstand the FDA’s PCCP framework\, how it relates to iterative improvements in software\, and its applications for medical devices and IVDs.\nLearn how to prepare effective PCCP submissions with considerations for risk management and post market surveillance documentation.\nExplore strategies for integrating PCCPs into regulatory and product lifecycle planning.\nIdentify and address challenges in PCCP implementation.\nGain practical insights from real-world examples and FDA guidance.\n\nReserve Your Spot
URL:https://criterionedge.com/event/fda-pre-determined-change-control-plan-pccp-recommendations-for-planning-your-strategy-and-approach/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Webinar-Graphic-Jan-29th-2025.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250305T120000
DTEND;TZID=America/Chicago:20250305T130000
DTSTAMP:20250306T175847Z
CREATED:20250218T235731Z
LAST-MODIFIED:20250306T175847Z
UID:6639-1741176000-1741179600@criterionedge.com
SUMMARY:The Current State of Medical Device Regulations: Strategies to Support a Successful Technical Documentation Assessment (TDA)
DESCRIPTION:Here we are\, nearly eight years after the publication of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and Medical Devices Regulation (EU) 2017/745 (MDR). As the May 2025 deadlines loom\, many manufacturers are facing the reality of what implementing these regulations actually entails. While the manufacturers seem to have been given more time\, a lack of clarity about clinical evidence expectations has left many companies struggling.   \nIn spite of these extended deadlines\, manufacturers continue to face challenges in implementing these regulations. Key pain points include:  \n\nEscalating costs of obtaining and maintaining certifications\, leading to budget uncertainty\nChallenges finding qualified regulatory affairs professionals and technical writers\nLack of clarity regarding clinical evidence requirements\nUnclear expectations from IVD and medical device Notified Bodies \n\nIn this webinar\, we will discuss strategies to support your Regulatory Affairs team as they strive to meet the requirements for technical documentation\, drawing from our experience with clinical evidence expectations for the Performance/Clinical Evaluation Reports (PERs/CERs) and Post Market Surveillance Reports for a wide range of medical devices and IVDs.  \nLearning objectives:   \n\nDiscuss common challenges (and deficiencies) identified during the Notified Body review of the PER/CER and PMS reports.\nExplain how Technical Documentation Assessments (TDA) can affect your timeline for certification.\nProvide real-world examples to illustrate the cost-effectiveness of preparing and planning for these extensive requirements early in your product’s lifecycle.\nDescribe our approach to meeting clinical evidence expectations through well-defined research questions\, targeted systematic literature reviews\, and well-organized templates.\n \n\nWATCH NOW
URL:https://criterionedge.com/event/the-current-state-of-medical-device-regulations-strategies-to-support-a-successful-technical-documentation-assessment-tda/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars,MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Webinar-Graphic-Mar-5th-2025-v1.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250326T120000
DTEND;TZID=America/Chicago:20250326T130000
DTSTAMP:20250327T154949Z
CREATED:20250304T221601Z
LAST-MODIFIED:20250327T154949Z
UID:6651-1742990400-1742994000@criterionedge.com
SUMMARY:Maximizing the Value of Literature Reviews for Medical Device\, From Competitive Intelligence to Market Success
DESCRIPTION:A well-executed systematic literature review (SLR) is more than just a regulatory compliance requirement—it’s a strategic asset for your entire organization. In this webinar\, we’ll explore how a good SLR can support regulatory submissions\, enhance competitive intelligence\, and facilitate post-market surveillance while saving time\, money\, and resources. Using real-world examples\, our experts will share best practices for designing an effective SLR that meets FDA and MDR requirements and serves as a valuable tool for R&D\, regulatory\, and marketing teams.  \nLearning Objectives:  \n\nUncover the Hidden Advantages of SLRs: Learn why a methodologically sound systematic literature review (SLR) outperforms traditional internet searches—and how it provides more credible\, comprehensive\, and actionable insights. \n\n\nMaster the Art of Search Strategy: Discover expert techniques for selecting the right keywords\, refining search criteria\, and optimizing data collection to ensure your SLR is both thorough and highly relevant to regulatory and business needs. \n\n\nTurn Published Data into a Strategic Asset Across the Organization: Explore how leveraging existing literature not only meets FDA and MDR expectations but also informs internal decision-making across teams\, competitive positioning\, and risk assessment. \n\n\nSee the Impact in Action: Through the examination of real-world scenarios\, you will gain a deeper understanding of how different teams—from R&D and regulatory affairs to marketing—can extract value from a well-executed SLR to drive smarter business and compliance strategies. \n\nWATCH NOW\n 
URL:https://criterionedge.com/event/maximizing-the-value-of-literature-reviews-for-medical-device-from-competitive-intelligence-to-market-success/
LOCATION:Webinar\, United States
CATEGORIES:MDR Webinars
ATTACH;FMTTYPE=image/png:https://criterionedge.com/wp-content/uploads/Webinar-Graphic-Mar-26th-20251.png
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250409T120000
DTEND;TZID=America/Chicago:20250409T130000
DTSTAMP:20260613T094559Z
CREATED:20250320T203944Z
LAST-MODIFIED:20260613T094559Z
UID:6697-1744200000-1744203600@criterionedge.com
SUMMARY:Maximizing the Value of Literature Reviews for IVD\, From Competitive Intelligence to Market Success
DESCRIPTION:A well-executed systematic literature review (SLR) is more than just a regulatory compliance requirement—it’s a strategic asset for your entire organization. In this webinar\, we’ll explore how a well-designed systematic literature review can support regulatory submissions\, enhance competitive intelligence\, and facilitate post-market surveillance while saving time\, money\, and resources. Using real-world examples\, our experts will share best practices for designing an effective SLR that meets FDA and IVDR requirements and serves as a valuable tool for R&D\, regulatory\, and marketing teams.  \nLearning Objectives:  \n\nUncover the Hidden Advantages of SLRs: Learn why a methodologically sound systematic literature review (SLR) outperforms traditional internet searches—and how it provides more credible\, comprehensive\, and actionable insights. \n\n\nMaster the Art of Search Strategy: Discover expert techniques for selecting the right keywords\, refining search criteria\, and optimizing data collection to ensure your SLR is both thorough and highly relevant to regulatory and business needs. \n\n\nTurn Published Data into a Strategic Asset Across the Organization: Explore how leveraging existing literature not only meets FDA and IVDR expectations but also informs internal decision-making across teams\, competitive positioning\, and risk assessment. \n\n\nSee the Impact in Action: Through the examination of real-world scenarios\, you will gain a deeper understanding of how different teams—from R&D and regulatory affairs to marketing—can extract value from a well-executed SLR to drive smarter business and compliance strategies. \n\nWATCH NOW
URL:https://criterionedge.com/event/maximizing-the-value-of-literature-reviews-for-ivd-from-competitive-intelligence-to-market-success/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars
ATTACH;FMTTYPE=image/webp:https://criterionedge.com/wp-content/uploads/ybwyseimrudigy1ria6s.webp
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250604T120000
DTEND;TZID=America/Chicago:20250604T130000
DTSTAMP:20260613T094529Z
CREATED:20250519T194523Z
LAST-MODIFIED:20260613T094529Z
UID:6703-1749038400-1749042000@criterionedge.com
SUMMARY:Leveraging AI in Regulatory Writing — Opportunities\, Oversight & What Medical Device Leaders Need to Know
DESCRIPTION:Artificial intelligence and large language models (LLMs) are transforming how medical device companies approach regulatory writing\, but questions remain around how to implement these tools effectively and responsibly\, and whether they actually save time and improve productivity.  \nIn this Ask the Expert session\, the team at Criterion Edge will explore how AI and LLMs can be used to improve the speed\, accuracy\, and cost-efficiency of regulatory and clinical writing tasks\, such as CERs\, PERs\, literature reviews\, and clinical data summaries. We’ll also examine how AI supports submission consistency across global markets like the U.S. and EU.  \nLearning Objectives   \n\nUnderstand how AI is being applied to accelerate regulatory writing workflows\, including CERs\, PERs\, and PMAs.\n\n\nExplore how AI can improve the efficiency and accuracy of systematic literature reviews and clinical data summaries.\n\n\nLearn what global regulatory agencies expect when AI is used in authoring or supporting submission documents.\n\n\nIdentify common risks and compliance considerations associated with AI-generated or AI-assisted content.\n\n\nGain a framework for evaluating AI-enabled vendors or service providers for regulatory writing support.\n\nWATCH NOW
URL:https://criterionedge.com/event/ask-the-expert-leveraging-ai-in-regulatory-writing-opportunities-oversight-what-medical-device-leaders-need-to-know/
LOCATION:Webinar\, United States
CATEGORIES:MDR Webinars
ATTACH;FMTTYPE=image/webp:https://criterionedge.com/wp-content/uploads/sjywx8mtykhpy6v0gimr.webp
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250924T120000
DTEND;TZID=America/Chicago:20250924T130000
DTSTAMP:20260613T094449Z
CREATED:20250821T152527Z
LAST-MODIFIED:20260613T094449Z
UID:7139-1758715200-1758718800@criterionedge.com
SUMMARY:Maximizing the Value of Literature Reviews in Pharma\, From Competitive Intelligence to Market Success
DESCRIPTION:In the pharmaceutical industry\, systematic literature reviews (SLRs) can be a valuable tool — not just for regulatory submissions\, but as a strategic foundation for drug development\, clinical trial design\, and commercialization\, feasibility\, supporting IND/NDA filings\, and identifying unmet needs. Understanding the full scope of their strategic value can help teams align evidence generation with business objectives and regulatory demands. \nIn this webinar\, our experts will show how pharmaceutical companies can unlock the full potential of SLRs to support regulatory requirements\, inform internal decision-making\, and improve competitive positioning. Using real-world pharmaceutical-focused examples\, we’ll discuss when and how to deploy an SLR\, and the benefits of working with experienced external partners like Criterion Edge to streamline timelines and elevate quality. \n\nUnderstand the Strategic Role of SLRs in Pharmaceutical and Combination Device Development\nLearn how SLRs support regulatory filings while also guiding early-stage development\, clinical planning\, and lifecycle management. Understanding the full scope of their strategic value can help teams align evidence generation with business objectives and regulatory demands.\nDesign an SLR That Serves Both Regulatory and Commercial Goals\nDiscover how a well-designed search methodology improves evidence quality and generates insights that can also be leveraged by cross-functional teams—from R&D and Medical Affairs to Sales and Marketing. For executives overseeing cross-functional teams\, aligning SLR outputs to multiple internal stakeholders increases the ROI of evidence generation efforts and reduces redundancy.\nKnow When to Bring in the Experts\nIdentify when your internal team may benefit from partnering with an experienced team like Criterion Edge to ensure scientific rigor\, regulatory alignment\, and delivery of publication- or submission-ready outputs. Understanding when and why to outsource can help executives mitigate delays and improve quality across submissions\, strategy decks\, and decision-support materials.\n\nWATCH NOW
URL:https://criterionedge.com/event/maximizing-the-value-of-literature-reviews-in-pharma-from-competitive-intelligence-to-market-success/
LOCATION:Webinar\, United States
CATEGORIES:Pharma Webinars
ATTACH;FMTTYPE=image/webp:https://criterionedge.com/wp-content/uploads/scukxxqtmpeiazorv8kj.webp
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260923T080000
DTEND;TZID=America/Los_Angeles:20260923T090000
DTSTAMP:20261028T184230Z
CREATED:20260923T141200Z
LAST-MODIFIED:20261028T184230Z
UID:11387-1790150400-1790154000@criterionedge.com
SUMMARY:Turn Scientific Information into Organization-Wide Insights with AI
DESCRIPTION:As scientific literature continues to grow\, traditional systematic literature reviews (SLRs) can leave valuable insights siloed in individual reports. AI-powered evidence intelligence can help life sciences teams make scientific evidence more accessible\, reusable\, and actionable across the organization. \nIn this webinar\, our experts explore how pharmaceutical and medical device companies can combine AI\, systematic literature review methodology\, and human scientific expertise to improve evidence management\, support regulatory readiness\, and reduce duplicated effort. \n\nMove Beyond One-Time Literature Reviews\nLearn how continuous literature monitoring can help teams identify emerging evidence\, risks\, gaps\, competitor activity\, and changes in the state of the art.\nUnderstand Where AI Fits in the SLR Process\nExplore how AI can support literature discovery\, screening\, categorization\, and summarization—while experienced scientists provide the interpretation and regulatory context needed to maintain rigor.\nCreate a Shared Evidence Foundation Across Teams\nDiscover how structured\, reusable evidence can support Regulatory Affairs\, Medical Affairs\, R&D\, and Clinical teams while improving consistency and efficiency.\n\nWatch Now
URL:https://criterionedge.com/event/turn-scientific-information-into-organization-wide-insights-with-ai/
LOCATION:Webinar\, United States
CATEGORIES:Pharma Webinars
ATTACH;FMTTYPE=image/webp:https://criterionedge.com/wp-content/uploads/Turn-Scientific-Information-into-Organization-Wide-Insights-with-AI-scaled.webp
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20261028T080000
DTEND;TZID=America/Los_Angeles:20261028T090000
DTSTAMP:20261028T185441Z
CREATED:20261028T183219Z
LAST-MODIFIED:20261028T185441Z
UID:12147-1793174400-1793178000@criterionedge.com
SUMMARY:Beyond AI: Why the Future of Scientific and Regulatory Writing Is Human + AI
DESCRIPTION:AI is becoming increasingly common in scientific and regulatory writing\, but using it effectively requires more than simply automating existing workflows. In regulated environments\, teams must balance AI-driven efficiency with scientific judgment\, evidence traceability\, quality control\, and human accountability. \nIn this webinar\, Criterion Edge explores a human + AI approach to scientific and regulatory writing\, including where AI can improve efficiency\, where it introduces risk\, and how teams can integrate AI without compromising regulatory rigor. \n\nUnderstand Where AI Adds Value—and Where It Falls Short\nExplore how AI can assist with literature screening\, data extraction\, drafting\, and error detection\, as well as common risks such as hallucinated citations\, missing evidence\, and incorrect clinical context.\nMaintain Regulatory Rigor and Evidence Traceability\nLearn why AI-assisted regulatory writing still requires documented methodologies\, reproducible evidence trails\, expert verification\, and human accountability throughout the workflow.\nBuild a Practical Human + AI Workflow\nDiscover how to introduce AI strategically\, validate outputs\, strengthen QC processes\, and use scientific experts for the higher-level interpretation and decision-making AI cannot replace.\n\nWatch Now
URL:https://criterionedge.com/event/beyond-ai-why-the-future-of-scientific-and-regulatory-writing-is-human-ai/
LOCATION:Webinar\, United States
CATEGORIES:IVDR Webinars,MDR Webinars,Pharma Webinars
ATTACH;FMTTYPE=image/jpeg:https://criterionedge.com/wp-content/uploads/zoom-webinar-graphic-261028.jpg
ORGANIZER;CN="Criterion Edge":MAILTO:support@criterionedge.com
END:VEVENT
END:VCALENDAR