When: 7 June 2022
Time: 08.45 - 17.15 BST (GMT+1)
Location: Online
Also available as a face to face course, please click here for the face to face registration option
Course overview
The MDR brought big changes in Europe for companies with products incorporating a delivery device - eg, pre-filled syringes, auto-injectors and inhalers. The US and other regions are also focusing more on how to regulate these increasingly technical products appropriately. As such, this course will cover:
- An introduction to combination products
- The evolving regulatory landscape
- The impact of the new EU Medical Device Regulation
- New guidance documents
- Considerations for development of "combined products", including design controls and human factors
- The challenges, similarities and differences between the EU, US and emerging markets
- Industry case study
Benefits to delegates
- Understand the current legislation and guidelines
- Learn about solutions to the practical, technical and regulatory issues
- Implement the changes in MAA submissions which the MDR brought about
- Talk to the experts and share experiences with your peers
- Become equipped to deal with different global markets
CPD: This course provides 8 CPD hours upon successful completion.
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Programme
The latest programme is available to download HERE
Presenters
The course will be chaired by Janine Jamieson and Margareth Jorvid
- Tim Chesworth, AstraZeneca
- Louise Place, GSK
- Ann Jans, FAMHP
- Christiana Hofmann, TUV SUD notified body
- John (Barr) Weiner, FDA
- Christina Moerk Hansen, Ralex Consulting
- Isabelle Mingam, UCB
Suitable for
- Anyone working in regulatory affairs.
- Individuals who are interested in the implications of combining medical technology and medicines.
- Device component suppliers to the pharmaceutical industry
Pricing
| Type |
Member |
Non-member |
| Standard |
£550+VAT |
£675+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
|
£412.50+VAT
|
£506.25+VAT |
Those working for charities, patient groups or are in full-time education
|
£275+VAT |
£337.50+VAT |
*VAT, if applicable, is charged at VAT rate of 20%
Related courses
Module 20: Regulation of Electrical, Electronic and Software Devices
Next steps
Module 18: Drug-device Combinations and Other Technologies - Register your interest