TOPRA Summit

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.

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



Claus Bolte
Chief Medical Officer,
SwissMedic


Paul Catchpole
Value & Access Policy Director, ABPI


Shirley Hopper
Deputy Director Innovative Medicines, MHRA 
 

Alessandro Lazdins Regulatory Policy and Intelligence Manager, CEPI



Dr. Dan O’Connor
Director, Regulatory Policy
& Early Access, ABPI 
 



Jennifer Prescott 
Programme Director HTA Process and Operations
NICE

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.

 

When
15/02/2024
Where
London UNITED KINGDOM
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