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Wednesday, February 6 • 16:45 - 18:00
#S0104: Evidence Generation as a Continuum: Can We Benefit from Advice?

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Component Type: Session
Level: Intermediate

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?

Chair

Virginia Lee Acha, PhD, MSc

Speaker

Evidence Generation as a Continuum: Can We Benefit from Advice?
Isabelle Stoeckert, PharmD

Post-Licensing Evidence Generation: The Role for the Regulator
Peter Mol, PhD, RPh

Post-Launch Evidence Generation: EUnetHTA Pilot and the Implications for Value Assessment
Irena Guzina, PharmD, MPH, MSc

Evidence Generation for Medicines: How Does this Support Patients?
François Houyez


Speakers
avatar for Peter Mol

Peter Mol

European representative (alternate),, MEB, Netherlands
Peter Mol is a principal assessor at the Dutch Medicines Evaluation Board and a member (vice chair) of EMA’s Scientific Advice Working Party. He is chair of the EMA Cross-Committee Task force on Registries. He is also a professor of drug regulatory science at the University Medical... Read More →
avatar for Irena Guzina

Irena Guzina

Scientific Project manager, HAS
Irena Guzina is a Pharmacist with a Master degree in Quality Control and Public Health. She has joined HAS in 2011, where she is working as Project manager at the Department for the Assessment of Medical Procedures. Moreover, Irena Guzina is also part of HAS EUnetHTA team. She is... Read More →
avatar for Virginia Acha

Virginia Acha

AVP, Global Regulatory Policy, Merck Sharp & Dohme LLC, United Kingdom
Virginia (Ginny) has worked in industry and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She joined MSD in 2017 to lead regulatory policy efforts ex-US for innovation that leads to better... Read More →
avatar for François Houyez

François Houyez

Treatment Information and Access Director, Health Policy Advisor, European Organisation for Rare Diseases (EURORDIS), France
François is a patient and works at the European Organisation for Rare Diseases as Director of Treatment Information and Access since 2003. He's been involved in EUnetHTA since the first Joint Action back in 2010, and supervises Eurordis policy and advocacy on HTA. François also... Read More →
avatar for Isabelle Stoeckert

Isabelle Stoeckert

Head RA EMEA, Bayer AG, Germany
Dr. Isabelle Stoeckert is Vice President and Head Regulatory Affairs Europe Middle East Africa at Bayer AG. With more than 20 years of experience in Regulatory Affairs she held several leading positions in a wide area of Regulatory and Scientific Affairs matters. Such as Vice President... Read More →

Wednesday February 6, 2019 16:45 - 18:00 CET
DIAlogue Space Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  01 Stakeholders and Regulatory System Optimisation, Session
  • Featured Topics Regulatory Science
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