Understanding Clinical Evaluations, Investigations and Post Market Clinical Studies

• Practical guidance for constructing a clinical evaluation report (CER) with medical writing advice
• Review tips to show equivalence and conduct a literature review with case study examples
• Discuss and evaluate the impact of the new Regulation on clinical evaluations and investigations to ensure you remain compliant and can manage the transition smoothly
• Examine how the clinical evaluation report is linked to post market surveillance and the risk management plan
• Assess post market clinical studies for existing products and examine how requirements will change with the new Regulation

Beata Wilkinson

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:

• Regulatory affairs
• Clinical development
• Medical writing
• Quality
• Engineers
• Scientists