Joint Regulatory and HTA Advice: Getting Ready for 2025

Joint Regulatory and HTA Advice: Getting Ready for 2025
The TOPRA Roundtable programme has been designed to enable regulatory affairs professionals to discuss their challenges and learn from each other’s experiences in industry and agencies. They offer the chance to be part of a unique learning experience which will enable you to contribute to lively debates and develop action plans that you can implement in your organisation with confidence.



When
: 2 July 2024
Where: TOPRA OFFICE, 3 Harbour Exchange, London, E14 9GE, United Kingdom 
Time: 12:00 - 17:00

Who Should Attend?



This session is relevant to anyone who is preparing for the HTA Regulation (The Regulation on Health Technology Assessment (EU) 2021/228) - either for their team/ organisation or on behalf of another. It will also be useful to those who want to prepare their organisation to establish a process for seeking and using this guidance.



Areas of Discussion

The discussion will be as free flowing as possible around the following key discussion points:

  • Impact on Product Pipeline: How can information, advice and guidance be transferred between products at different development stages?
  • Impact on Timelines: Is it possible to backdate any of the information, advice and guidance? What if the advice changes whilst I am still in development?
  • Preparing for and Managing Delays: How can I pre-empt and work around any delays in securing advice? Are there strategies we can use in the development planning?

CPD: This course provides 3 CPD hours upon successful completion

To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.


Speakers

 

Joseph Irwin FTOPRA, Director, XP Forte Regulatory Limited

Joseph has been working in Regulatory Affairs for over 30 year, he has also been a strong advocate for rare disease and paediatric medicines as he is also a patient representative for Spinal Muscular Atrophy. The new HTA Regulation will look at one of the most critical steps in making available treatments to patients in the EU. The Regulation came into force in 2022 and will be implemented in January 2025 initially with oncology and rare diseases but is expected to be implemented across all therapeutic indications in the future. We want to take the pulse of where Regulatory departments are at the moment on this eve of this new legislation being implemented.


Hilary Gray
   

Hilary Gray MTOPRA, Director, Regulatory Consulting, Syneos Health 

Hilary is an experienced senior regulatory professional with an extensive history within the pharmaceutical industry and a track record of delivering successful applications in USA and Europe. Her skills include management of complex regulatory submissions, leading cross-functional teams, strong communication with global regulatory health authorities, and delivering high quality regulatory documentation.


   

Pricing  

Standard

  • Member: £285+VAT*
  • Non-member: £365+VAT*
 
When
02/07/2024
Where
3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
Sign in or create an account to register Last day to register is 29/06/2024
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