Back to Agenda
Early Engagement to Enhance the Incorporation of Patient Experience Data in Drug Development Programs and Regulatory Decision-Making
Session Chair(s)
Steffen Thirstrup, MD
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, BSN, MS, RN
Director, Patient Focused Drug Development, OCD, CDER, FDA, United States
US Patient Representative
Karin Hoelzer, DVM, PhD
Senior Director, Policy and Regulatory Affairs, NORD, United States
EMA Update
Juan Garcia-Burgos, MD, PhD
Head of Public and Stakeholders Engagement Department, European Medicines Agency, Netherlands
EMA Update
Rosa Gonzalez-Quevedo
Scientific Research Officer, European Medicines Agency, Netherlands
US Industry Representative
Maria Apostolaros, JD, PharmD, MS, RPh
Deputy Vice President, Science and Regulatory Advocacy, PhRMA, United States
EU Industry Representative
Solange Corriol-Rohou, DrMed, MD
CEO, SCR Consulting, France
Have an account?