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Evidence Generation as a Continuum: Can We Benefit from Advice?
Session Chair(s)
Virginia Acha, PhD, MSc
Global Lead, Global Regulatory Policy
MSD, United States
We are generating new evidence about medicines in an ever more continuous cycle, with new sources and standards emerging across the globe. But how do decision makers use this evidence and do these assessments align over time? In this session, we look across the lifecycle of a medicine to explore evidence generation at different points in time and from different stakeholder perspectives. We ask participants to consider how scientific advice and assessments processes can help companies, healthcare systems and patients to navigate this changing horizon for evidence and assessment. How can we optimize the regulatory system to meet the challenges of tomorrow? Do we need new processes, guidelines or technologies?
Speaker(s)
Evidence Generation as a Continuum: Can We Benefit from Advice?
Isabelle Stoeckert, PharmD, PMP
Independent, Germany
Independent Regulatory Science Expert
Post-Licensing Evidence Generation: The Role for the Regulator
Peter Mol, PharmD, PhD
MEB, Netherlands
CHMP member, NL
Post-Launch Evidence Generation: EUnetHTA Pilot and the Implications for Value Assessment
Irena Guzina, PharmD, MPH, MSc
HAS, France
Medical Assessor, Coordinator of EUnetHTA WP5B PLEG Activities
Evidence Generation for Medicines: How Does this Support Patients?
François Houyez
European Organisation for Rare Diseases (EURORDIS), France
Treatment Information and Access Director, Health Policy Advisor
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