
The global agency network - how harmonisation and innovation are paving the way for the future of medicines regulation
When: 15 February 2024
Where: Hilton Canary Wharf Hotel, Marsh Wall, London E14 9SH
Time: 12:30 - 18:30 (GMT) / 13:30 - 19:30 (CET)
Supported by 
The TOPRA Summit will provide the chance to hear from regulators about the current state of the International Recognition Procedure as a path to accelerate approval of innovative medicines in multiple markets, as they work together to enable faster approvals.
Market access leaders will share the key parameters which regulatory affairs professionals should consider for the subsequent rapid access of such medicines. An industry leader will also reveal the key success factors for accelerating approvals, working alongside the regulatory and access stakeholder network, and examine what a ‘good regulatory system’ looks like.
The Summit will be an opportunity to not only hear about the current status of this evolving system for product approval, but also to discuss challenges and opportunities and share ideas about how to evolve the future framework in this multi-stakeholder forum for leading regulatory affairs professionals.
In this short video below, Claus Bolte, Chief Medical Officer at SwissMedic and a presenter on Session 1 explains why you should join us on 15 February 2024.
Programme
12:30 - 13:00 |
Registration & networking |
13:00 - 13:05 |
Welcome speech |
13:05 - 13:40 |
Session 1 - How can we optimise opportunities and flexibilities to secure early access for patients to innovative medicines?
Speakers:
- Shirley Hopper, Deputy Director Innovative Medicines, MHRA
- Claus Bolte, Chief Medical Officer, SwissMedic
|
13:40 - 13:55 |
Session 2 - Innovative and flexible regulatory framework - what does industry need? The industry perspective
Speaker:
- Dr. Dan O’Connor, Director, Regulatory Policy & Early Access, ABPI
|
13:55 - 14:25 |
Session 3 - Market Access – Getting the right treatment to the right patient at the right time, at the right price – what’s next? The HTA perspective
Speakers:
- Paul Catchpole, Value & Access Policy Director, ABPI
- Jennifer Prescott, Programme Director HTA Process and Operations, NICE
|
14:25 - 14:35 |
Comfort break |
14:35 - 14:50 |
Session 4 - CEPI’S regulatory strategy to deliver 100-day mission
Speaker:
- Alessandro Lazdins, Regulatory Policy and Intelligence Manager, CEPI
|
14:50 - 15:30 |
Panel discussion |
15:30 - 16:00 |
Networking break - Tea & Coffee |
16:00 - 16:50 |
Breakout session 1 |
16:50 - 17:05 |
Comfort break |
17:05 - 17:55 |
Breakout session 2 |
17:55 - 18:20 |
Feedback session |
18:20 - 18:30 |
Closing speech |
Presenters
CPD
This meeting offers 5 CPD hours for successful completion. To learn about why CPD is important, visit our Lifelong Learning page.
Pricing
-
Members: £265+VAT*
- Non-members: £325+VAT*
*VAT, if applicable, is charged at the rate of 20%.
Terms and conditions
Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions.