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Understanding Clinical Evaluations - Online Academy

A key course for professionals who are involved in clinical evaluations

4 week online course beginning on Monday 5th March 2018

Online Academy

The new Medical Device Regulation, due to be published in 2017, will result in significant changes to 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.

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

What is an Online Academy course? 

Online academy is a new online, interactive and engaging education tool designed to maximise learning for professionals with busy schedules and/or small training budgets.

The online academy brings alike professionals together and gives you the opportunity to share ideas and questions via the discussion forum creating your own professional community. Our on-demand feature means the content is available as and when you need it allowing greater flexibility to your professional development and learning. 

 

Over 4 weeks students will learn through:

  • 4 modules, split up into multiple bitesize recorded videos
  • Quizzes to test your knowledge
  • Revisit the content with unlimited access to all the materials for 2 months
  • Access the discussion forum to interact with other students
  • Direct contact with the trainer through the forum during the 4 weeks the course is running
  • Additional content such as materials and white papers available to download

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

What happens during an Online Academy course?

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This online academy course can be accessed from 5th March 2018. 1 module will be uploaded per week, allowing you to study at your own pace. Your trainer will welcome any questions that arise throughout your course.

Please note that full payment must be made prior to the course start date in order to receive your login details to begin the course.

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