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

Course overview

• 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

Programme

A copy of the programme can be found HERE

Module Leader

Adrian Keene - NAMSA

Speakers

Jane  Arnold Round - NAMSA
Rachel Gibbs - NAMSA
Paul Risborough - NAMSA
Kiren Ajab - NAMSA
Richard Vincins - 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: £1,545 +VAT*
• Delegates: £1,785 +VAT*

Discounted places

A limited number of discounted places are available at the rates below. Please email us at meetings@topra.org for a discount code before making your booking.

• Those working for regulatory agencies, government agencies or academic institutions: £1,338.75 +VAT*
• Those working for charities, patient groups or in full-time education: £892.50 +VAT*

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

Please note that discounted places are not valid for those enrolled on the MSc course and cannot be used in conjunction with any other offer.

Terms and conditions

By booking a place on this course you are agreeing to the training terms and conditions.