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Understanding Clinical Evaluations

4-week online course | 2 hours per week

1 June - 3 July 2020

Online Academy

The new Medical Device Regulation, published in 2017 and due to be fully implemented in 2020, will result in significant changes to clinical evidence, with more clinical data being required for 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.

This course is also available as a public training course - check the website for dates>>

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.

  • Practical guidance for constructing a clinical evaluation report (CER)
  • Discuss and evaluate the impact of the new Regulation on clinical evaluations to ensure you remain compliant and can manage the transition smoothly
  • Understand how to assess and analyse clinical data
  • Examine how the clinical evaluation report is linked to post market surveillance and the risk management plan
  • Comprehend the use of Clinical Evaluation throughout the product lifecycle

This course is aimed at professionals who are responsible for or involved in clinical evaluations in industry, consultancy, agencies, notified bodies and within CRO’s and may come from the following departments:

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

MDTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.

Modules are released on a weekly basis so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.

Watch the Online Academy Video

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