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Clinical Investigations and Post Market Clinical Follow-Up Studies - Online Academy

5 weeks - 1 hour per week

5 week online course beginning on Monday 2nd October 2017

Online Academy

The newly finalised Medical Device Regulation will mean significant changes to clinical evidence with more clinical data being required for riskier device products. This 5 module course will examine the requirements and design protocols of clinical investigations for new devices with case study examples. This course will also cover post market clinical follow -up studies for existing products and will look at the impact of the new Regulation.

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 5 weeks students will learn through:

  • 5 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 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.

  • Understand protocol and regulation around Clinical Investigation planning and conduct
  • Assess post market clinical studies for existing products and examine how requirements will change with the new Regulation
  • Consider key factors in study design
  • Investigate PMCF study design and how to implement PMCF

This course is aimed at professionals who are involved with clinical investigations in industry, consultancy, agencies, notified bodies and within CROs and include the following departments and job titles:

  • 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 2nd October 2017. 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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