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Understanding Clinical Evaluations, Investigations and Post Market Clinical Studies

Includes the NEW Medical Devices Regulation

18 - 19 November 2020

Radisson Blu Edwardian Kenilworth, London

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. 

  • 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

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:

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

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

Head of Regulatory Affairs,

Oticon Medical AB

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!

Regulatory Affairs Specialist, Greatbatch Medical

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!

Q&R Post-Market Surveillance, Philips

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.

Clinical Project Scientist, JRI Orthopaedics

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.

Regulatory Affairs Director, Greatbatch Medical

Free Recorded Webinar: Clinical evaluations, incorporating biological evaluation and PMCF with Sam Martin

In c.30 minutes, gain an overview of clinical evaluation and how it interacts with biological evaluations and post marketing clinical follow-up. Webinar highlights include:

  • Introduction to clinical evaluations
  • Discover how to incorporate biological evaluations into the clinical evaluation
  • Examine best practices to combine PMCF data into the clinical evaluation

This webinar is led by Sam Martin, chair of Day 2 of the Medical Device School. To find out more about this course please visit our course website here.

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