This session’s topic: The Importance of Clinical Data: Sources of Data, Literature Searches, Weighting & Appraisal and Effective Presentation in your CER or PER
During this 30 minute Q&A session, our President Laurie Mitchell answers questions on how to generate, analyze, and assess clinical data pertaining to your IVD or medical device. In addition, she discusses the best practices for conducting literature searches and how to effectively present your data in your Clinical Evaluation Report or Performance Evaluation Report.
Who should watch this webinar?
Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve clinical evaluation reports or performance evaluation reports for EU MDR or IVDR submissions.
How to Empower Data-Driven Decisions in Your Organization
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, clinical literature is also required for compliance with global regulatory requirements. 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.
[Ask the Expert] Safety and Performance Objectives and Acceptance Criteria for the PER
Join us for a LIVE Q&A session on January 26, 2022, at 11AM PST / 2PM EST with President Laurie Mitchell and Dr. Sarah Chavez. They will be answering questions regarding best methods and practices of identifying safety and performance measures and acceptance criteria for the performance evaluation report.
Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.
If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.
3rd Party Cookies
This website uses Google Tag Manager and Pardot's tracking features to collect information such as the number of visitors to the site, and the most popular pages. Keeping this cookie enabled helps us to improve our website.
Please enable Strictly Necessary Cookies first so that we can save your preferences!