When: 9 May 2019
Where: TOPRA, 6th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE
Time: 09.00 - 17.00
As discussed in the joint Human Medicines/ Medical Device session at the TOPRA 2018 Symposium, 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 course will cover:
- An introduction to combination products
- The evolving regulatory landscape
- The impact of the new EU Medical Device Regulation
- New guidance documents
- The challenges, similarities and differences between the EU, US and emerging markets
Benefits to delegates
CPD: This course provides 8 CPD hours upon successful completion
- 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 2020
- Talk to the experts and share experiences with your peers
- Become equipped to deal with different global markets
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
The course programme will be available in due-course.
| Janine Jamieson
JCombinations AB &
| Margareth Jorvid
Methra Uppsala AB
- 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
Book now at 2018 registration fees!
A limited number of discounted places are available at the rates below.
Please email us at email@example.com for a discount code before making your booking.
|Those working for regulatory agencies, government agencies or academic institutions
|Those working for charities, patient groups or are in full-time education
*VAT, if applicable, is charged at VAT rate of 20%
Module 20: Regulation of Electrical, Electronic and Software Devices
Module 18: Drug-device Combinations and Other Technologies - Register your interest