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 - 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 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
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.
Click here to download a copy of the course programme.
- 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
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