The now finalised Medical Device Regulation will mean significant changes to clinical evidence with more clinical data being required for riskier device products.
Day One (Clinical Evaluations) will focus on clinical evaluation reports and will provide you with a comprehensive understanding of literature reviews, proving equivalence, medical writing and managing CER's throughout the life-cycle of a product.
Day Two (Clinical Investigations and Post Market Clinical Studies) will examine the requirements and design protocols of clinical investigations for new devices. This day will also cover post market clinical studies for existing products and will look at the impact of the new Regulation.
Delegates will be able to cement this knowledge through case studies and practical exercises, with additional time on the course provided to discuss the implications of Brexit.
Beata Wilkinson, PhD, MTOPRA, is the Medical Director responsible for services related to clinical evaluation of medical devices at Cactus Communications, a global medical communications agency. She works closely with the CACTUS team of medical writers involved in the development of Clinical Evaluation Reports (CERs). In addition to coaching writers and reviewing their CER drafts, she also reviews CERs developed by clients’ inhouse writers for Rev 4 compliance before Notified Body audits. Beata’s previous position was as Director of Regulatory Services Department at CROMSOURCE, an international CRO, where she advised clients in the medical device industry on clinical evaluation and Post Market Clinical Follow-up (PMCF) study plans. Prior to that, Beata served as a Clinical Evaluation Program Specialist at ConvaTec, a global medical device manufacturer, where she was responsible for overseeing the preparation of the company’s CERs. Beata has extensive experience of regulatory and medical writing, consulting, and training as well as management of client-focused projects.
This course is aimed at professionals who are responsible for or involved in clinical evaluations and investigations in industry, consultancy, agencies, notified bodies and within CRO’s and include the following departments and job titles:
The course material was very comprehensive with a good mix of information on regulations and guidance and practical advice on how to comply. I enjoyed the informal atmosphere!
I chose this course to get an overall knowledge about clinical evaluations and really enjoyed the exchange of ideas with the course leader. A lot of information was shared!
I chose this course as I wanted to learn how to write more effective clinical evaluation reports. The run-through of a template CER was particularly useful.
I came to learn the current best practices in CER and PMCF and during the course I really enjoyed the specifics on CER methods and PMCF types and reasons to choose each.