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 how examine how requirements will change with the new Regulation

Victoria Cavendish is a highly skilled Clinical Affairs specialist with a solid understanding of the associated Quality and Regulatory landscape gained over 15 years within academia, medical device manufacturing companies, and Clinical Research Organisations. Victoria has held senior positions at various medical device companies such as Premier Research, Reckitt Benckiser and Novartis Pharma AG managing successful clinical teams.

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