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
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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.
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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.
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Pricing
Standard
- Member: £285+VAT*
- Non-member: £365+VAT*