When: 28 April 2020
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. If you require further information please e-mail meetings@topra.org
Course overview
There are big changes ahead in Europe for companies with products incorporating a delivery device - e.g, 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
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
Benefits to delegates
- Understand the current legislation and guidelines
- Learn about solutions to the practical, technical and regulatory issues
- Prepare for significant changes in MAA submissions from May
- 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
Download a copy of the programme here.
Presenters
Pricing
Simply log in or create an account and register below.
| 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%
Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions
Related courses
Module 20: Regulation of Electrical, Electronic and Software Devices - Register your interest
Next steps
Module 18: Drug-device Combinations and Other Technologies - Register your interest