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Early Engagement to Enhance the Incorporation of Patient Experience Data in Drug Development Programs and Regulatory Decision-Making
Session Chair(s)
Steffen Thirstrup, MD, PhD
Chief Medical Officer
European Medicines Agency, Netherlands
Integrating patient-experience data (PED) in medicines regulation for better patient-centered outcomes is a priority for medicines regulators, including the FDA and the EU network. The FDA’s program on patient-focused drug development (PFDD) has yielded 4 scientific guidelines on PED, while in the EU work is ongoing to produce a reflection paper outlining pathways for progress, marking an initial step toward smoother PED integration in medicine development. The session will present the US and EU's position in this regard and draw on the experience in applying existing guidance to date.
Learning Objective : Describe the work done by FDA’s Patient-Focused Drug Development (PFDD) program on scientific guidelines on patient-experience data (PED), challenges and future outlook; Describe how work is progressing in the EU to foster the generation and use of patient-experience data in medicines regulatory decision-making.
Speaker(s)
Co-Chair
Robyn Bent, MS, RN
FDA, United States
Director, Patient Focused Drug Development, OCD, CDER
US Patient Representative
Karin Hoelzer, DVM, PhD
NORD, United States
Senior Director, Policy and Regulatory Affairs
EMA Update
Juan Garcia-Burgos, MD, PhD
European Medicines Agency, Netherlands
Head of Public and Stakeholders Engagement Department
EMA Update
Rosa Gonzalez-Quevedo
European Medicines Agency, Netherlands
Scientific Research Officer
US Industry Representative
Maria Apostolaros, JD, PharmD, MS, RPh
PhRMA, United States
Deputy Vice President, Science and Regulatory Advocacy
EU Industry Representative
Solange Corriol-Rohou, DrMed, MD, PhD
AstraZeneca , France
Senior Director, Global Regulatory Affairs & Policy, R&D, Europe
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