As part of the conformity assessment route and risk management plans all medical devices require an evaluation of the existing clinical data on similar devices - this then makes up a part of the technical documentation. This requirement is part of the Medical Device Regulation (MDR) which was brought in to modernise the Directives, maintain safety for all patients across the EU and update legislation to keep up with technological advances. To improve patient safety the MDR focuses on clinical evidence with more clinical data being required for riskier device products.
This 4 module course will focus on clinical evaluation reports and will provide you with a comprehensive understanding of literature reviews, proving equivalence, and managing Clinical Evaluation Reports throughout the life cycle of a product.
Victoria Cavendish is a highly skilled Clinical Affairs Specialist with an extensive 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:
We're looking forward to welcoming our attendees and expert course leaders at Understanding Clinical Evaluations, Investigations and Post Market Clinical Studies.
Our number one priority is the safety of our delegates and colleagues, and there are always measures in place at our venues to safeguard your health and safety. There are extra measures in place for 2020 in light of developments with COVID-19.
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Time efficient course, providing all necessary basic information about clinical evaluation and the related regulatory requirements. Also the templates provided are useful
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.