EU HTA: Challenges and Opportunities
With the upcoming introduction of the new EU HTA guidance in January 2025, sponsors in the pharmaceutical, Biotech and medical device sectors will face a significant regulatory shift. This change will demand the generation of a substantial body of evidence within stringent timelines. To help you prepare for this transition, we are hosting an informative webinar that will introduce the key aspects of EU HTA and its potential implications for your organization.
Date/Time: Thursday, 17th October 2024, 3pm BST / 10am EDT / 7am PDT
Speakers:
• Stephen Corson PhD, Associate Director, Statistics & Technical Solutions
• Eileen Holmes PhD, Associate Director, Statistics
• Lauren Rojas, Principal Statistician
• Melanie McGuigan, FSP Manager/ Programming Manager
Webinar Highlights:
• Introduction to EU HTA
• Key Differences from EMA
• Understanding PICOs
• Challenges and Opportunities
This webinar is an essential resource for regulatory professionals, clinical researchers, and anyone involved in HTAs.
Join us to ensure your organization is well-prepared to meet the demands of the new EU HTA guidance and to position your products for success.
Your Statistical Experts
Stephen Corson, PhD
Associate Director, Statistics & Technical Solutions
Stephen Corson, PhD is Associate Director, Statistics and Technical Solutions at Phastar where he provides statistical leadership to trials in all phases of the drug development pipeline in multiple therapeutic areas. Stephen joined Phastar from academia where he was a lecturer and director of the Mathematics and Statistics Consultancy and Training unit, providing statistical support and training professionals working in business, academia and industry.
Eileen Holmes, PhD
Associate Director, Statistics
Eileen Holmes, PhD is an Associate Director in Statistics at Phastar and brings a wealth of experience in medical statistics in health technology assessment, real world evidence and clinical trials. She has worked in a variety of organizations including CROs, academia and public health statistics.
Lauren Rojas
Principal Statistician
Lauren Rojas is Principal Statistician at Phastar, where she leads statistical analysis and reporting of clinical trials. Additionally, Lauren has worked as a Statistical Consultant at the University of Sheffield, gaining experience in data analysis and reporting for a range of clients including health and personal care companies and hospitals.
Melanie McGuigan
FSP Manager/ Programming Manager
With nearly a decade of programming and data analysis experience, Melanie works as the FSP Manager/Programming Manager at Phastar, having previously held roles such as Principal Programmer and Senior Programmer. Previously, she worked at PPD as a Programmer Analyst, and across other organizations, showcasing a diverse skill set across various programming and analytical roles.
Visit the Knowledge Centre
Access our library of webinar recordings including:
- FSP Strategic Partnerships & Fuel Efficient Drug Development
- Study Design Considerations for Biotechs
- Use of Expert Prior Elicitation for Clinical Research
