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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?
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.
Content is the user experience. Make your words count.
Key Takeaways
Who are the Panelists?
Laurie W. Mitchell, President, Criterion Edge
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Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
Click here to watch the recording of this webinar.
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.
In 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 and join with other regulatory, notified body and industry leaders as panelists at the pre-conference workshop “New Requirements for In Vitro Diagnostics”.
Attendees to this Criterion Edge webinar will benefit from key insider insights gleaned from this meeting, 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. Most companies are in the early stages of planning for IVDR, so the goal of this webinar is to provide helpful suggestions for IVDR planning and preparation from the perspective of experienced regulatory writers.
Key Takeaways
Who Should Watch?
Those Regulatory, Quality, and Clinical leaders and teams who are tasked with the development, writing, review, or approval of performance evaluation reports for IVDR submissions.
Who are the Panelists?
Dr. Sarah Chavez, Director, IVD & Scientific Writing Services
Sign up for future webinars here.
Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
In 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.
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Those 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.
Every 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.
Download our free white paper, Systematic Literature Review: How to Empower Data-Driven Decisions in Your Organization to read more on this topic.
You can also watch our webinar on this topic.
Our President Laurie Mitchell joins Jennifer Tetzlaff, Research Product Specialist with Evidence Partners, to talk to you about the following points:
What 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.
Click here to watch the recording of this webinar.
There 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.
Those 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.
Every 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.
Download our free white paper, Systematic Literature Review: How to Empower Data-Driven Decisions in Your Organization to read more on this topic.
You can also watch our webinar on this topic.
Our President Laurie Mitchell joins Jennifer Tetzlaff, Research Product Specialist with Evidence Partners, to talk to you about the following points:
Fill out this form, or contact us at info@criterionedge.com, and we would be happy to answer any of your questions as well as book you an appointment to discuss your project needs during a time that works for you.
In this discussion, we provide an overview of how to plan and coordinate change within an organization to meet upcoming EU IVDR regulatory requirements. We will be highlighting key steps involved in helping medical affairs transition to a more rigorous regulatory environments, and how to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
In this discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.
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