When: 20–22 February 2019
Where: TOPRA. 6th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE
Start time Day 1: 13.00 | End time Day 3: 15.30
Course overview
The Masterclass will cover both the current regulatory environment and the new regulations as they come into effect and cover:
- The current EU regulatory environment including: the regulatory environment in other jurisdictions such as Japan, China and Brazil
- Definitions and classification of IVD devices
- Conformity Assessment
- Quality Management Systems
- Risk management
- Technical documentation
- Performance data and product claims
- Post market surveillance, vigilance and FSCA
- Other relevant legislation
- Companion diagnostics and other emerging technologies
This course will enable you to:
- Demonstrate a critical understanding of the regulatory environment in the EU and other territories and critically evaluate how these compare
- Critically evaluate the challenges involved in conducting clinical evidence studies using IVD products, giving consideration to the differences between these products and other medical devices in the design and production of clinical data
- Demonstrate critical understanding of the quality system requirements associated with the manufacture and supply of IVDs
- Demonstrate critical understanding of the roles of the different stakeholders involved in the manufacture, supply and regulation of IVDs
- Be able to recommend development strategies for IVD products that will meet global requirements
- Explain the regulatory requirements for vigilance and post-market surveillance for IVDs and be able to make recommendations about the implementation of a surveillance strategy
- Explain the regulatory requirements for the development of an IVD medical device and be able to guide the preparation of the IVD technical documentation needed for CE Marking
- Critically appraise and evaluate communications from regulatory bodies and research publications regarding IVDs
CPD: This course provides 19 CPD hours upon successful completion
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Programme
Download the course programme
Module Leader
Aaron Cousins - VP, Global Quality & Regulatory Affairs, Beckman Coulter
Aaron Cousins has worked in MedTech Q&RA for more than 20 years. He has held multiple roles at three MedTech companies and is currently the Global Vice President of Quality & Regulatory Affairs at Beckman Coulter. Aaron is an active TOPRA volunteer, who over the past 8 years has led the development and delivery of TOPRA’ s Medical Device BASICS, Medical Device INTRODUCTORY & MSc IVD courses. He has served as Chair of the Medical Device Special Interest Network and acted as advisor to the TOPRA board, providing expert opinion and guidance from a device & IVD perspective. He is also a past student of the TOPRA / Cranfield MTRA MSc and a TOPRA Fellow.
Presenters
Maurizio Suppo, Ph.D - Co-owner and Principal Consultant, Qarad
Maurizio Suppo has more than 30 years of experience in the field of regulatory affairs and quality systems. He held executive positions at Sorin Biomedica (now DiaSorin), Becton Dickinson, Dade Behring and Siemens Healthcare. He has been the Director of the European Diagnostic Manufacturers Association (EDMA) and had a significant role in the development of the European IVD Directive 98/79/EC. His knowledge and experience in RA&QS go beyond the European borders. Dr Suppo joined Qarad in July 2012 and became partner and co-owner in January 2016. He is a regular speaker and chairman at international conferences and published more than 20 articles in the specialised press.
Ben Jacoby - Consultant, Cambridge RA Ltd.
Liz Harrison - Technical Team Manager - IVD, BSI
Stephen Lee - Senior Regulatory Policy Manager - IVDR, MHRA
Stuart Angell - Novartis
Gill Morgan - Director, Sestria Ltd
Robyn Meurant - Executive Director, Regulatory Services - IVDs and Medical Devices, NSF Health Sciences Ltd
Nancy Consterdine - Independent Consultant, IVDeology Ltd
This course is suitable for
- Students of the TOPRA MSc programme
- Delegates from the regulatory affairs industry who wish to develop their knowledge of the requirements for a new active substance
- 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 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
|
|
£1275+VAT
|
Those working for charities, patient groups or in full-time education
|
|
£1275+VAT |
|
- VAT, if applicable, is charged at the rate of 20%
- The registration fee does not include accommodation
- Refreshments and lunch are included in the registration fee
Related courses:
MSc Module 13: Principals of Medial Device Regulatory Affairs
Next steps
Module 10: Leadership and Strategic Management in Regulatory Affairs
Module 12: Data Management and Digitalisation of Medical Devices
Module 21: US Regulation of Medical Devices
Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions