M1522 Clinical Evaluation of Medical Devices

M1522 Clinical Evaluation of Medical Devices
This Masterclass is also Module 15 of the MSc Regulatory Affairs and will help you to understand the broad scope of clinical investigation and the regulatory processes required with the alternative routes to demonstrate compliance.

When: 23-25 May 2022
Where: TOPRA Office, 6th Floor, 3 Harbour Exchange, London, E14 9GE, UK
Day 1 start time: 13:00 BST | Day 3 end time: 16:30 BST 

Also available as a virtual course, please click here for the virtual registration option

Course overview

The Masterclass will cover:

  • EU MDD 93.42 to WU MDR 2017/745
  • Who should perform the clinical evaluation
  • Clinical evaluation for marketed devices PMS/PMCF, PSUR and SSCP
  • The place of Clinical Evaluation within device lifecycle and technical documentation
  • The equivalence assessment under MDR
  • Clinical investigations under MDR
  • Types of clinical studies
  • ISO14155
  • Clinical global strategy requirements - US FDA Specifics

Benefits to delegates

  • Demonstrate a systematic understanding and critical awareness of the regulatory requirements, directives and associated documentation relating to the clinical evaluation
  • Critically evaluate the methodology and conduct of clinical research
  • Appraise the factors that influence the quality of clinical evaluation
  • Be able to critically evaluate existing literature and assess the need for clinical evaluation
  • Demonstrate the ability to critically analyse the legal documentation relating to clinical evaluation of devices
  • Deal with complex issues both systematically and creatively and make sound judgments in the absence of complete data and communicate conclusions clearly to non-specialist audiences
  • Critically appraise and evaluate communications from regulatory bodies and stakeholders relating to the conduct of clinical research
CPD: This course provides 14 CPD hours upon successful completion
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.

Programme

A copy of the draft programme can be found HERE

Module Leader

Adrian Keene - NAMSA

Speakers

Jane  Arnold Round - NAMSA
Rachel Gibbs - NAMSA
Paul Risborough - NAMSA
Dan Whitter - NAMSA
Carla Wiese - NAMSA

This course is suitable for

  • Students of the TOPRA MSc programme
  • Delegates from the healthcare regulatory affairs profession who wish to develop their knowledge of the requirements for the clinical evaluation of medical devices
  • Delegates from allied industries who wish to have a comprehensive understanding of the subject
  • Clinical trial experts who want to understand the regulatory side and work with the regulatory team

 

Pricing

    Standard

    • TOPRA MSc students: £1500 +VAT*
    • Delegates: £1700 +VAT*

    Discounted places

    A limited number of discounted places are available for those working for regulatory or government agencies, academic institutions, charities or patient groups, and/or those in full time education. Price: £1275+VAT*.

    Please email us at meetings@topra.org for a discount code before making your booking.

    *VAT, if applicable, is charged at the rate of 20%.

    Terms and conditions

    By booking a place on this course you are agreeing to the training terms and conditions.
    When
    23/05/2022 13:00 - 25/05/2022 16:30
    Where
    TOPRA 6th Floor 3 Harbour Exchange London E14 9GE UNITED KINGDOM
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