When: This course will take place on three consecutive Fridays: 5 June, 12 June and 19 June 2020
Time: 14:00 BST (GMT +1) - 17:30 BST (GMT+1)
Where: Online
TOPRA is committed to continuing to support the education of regulatory professionals in this unprecedented situation. However, in light of recent developments and the advice from health authorities, we have made the decision for this course to go ahead as an interactive online course on the same date with many opportunities for questions to the speakers. All delegates already booked on the course will be individually contacted and if you require further information please email meetings@topra.org.
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
Click here to download the current programme.
Speakers
-
Adrian Keene - Director EMEA, Consulting Services, NAMSA (Module Leader)
- Jane Arnold - Principal Regulatory Consultant, NAMSA
- Matt Royle - Principal Regulatory Consultant, NAMSA
- Sandra Welch - Director of Clinical Research Services Europe, NAMSA
- Dan Whitter - Manager, Clinical Study Managers, NAMSA
- Jason Kreszack - 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
Pricing
Course fees:
| Type |
Student |
Delegate |
| Standard |
£1500+VAT |
£1700+VAT |
Discounted places
A limited number of discounted places are available for those working for regulatory or government agencies, academic institutions, charities, patient groups or full time education at £1275+VAT
Please email us at meetings@topra.org for a discount code before making your booking.
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
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- VAT, if applicable, is charged at 20%
- The registration fee does not include accommodation
- Refreshments and lunch are included in the registration fee
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Related courses:
Module 4: Regulatory Strategy for a New Active Substance: Global Clinical Development
Next steps
Module 16: Post Market Surveillance and Vigilance for Medical Devices
Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions