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Tuesday, June 18 • 8:00am - 9:00am
#206: Early Engagement to Enhance the Incorporation of Patient Experience Data in Drug Development Programs and Regulatory Decision-Making

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-561-L04-P; CME 1.00; RN 1.00

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 Objectives

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.

Chair

Steffen Thirstrup, MD, PhD

Speaker

US Patient Representative
Karin Hoelzer, DVM, PhD

Co-Chair
Robyn Bent, MS, RN

EMA Update
Juan Garcia-Burgos, MD, PhD

EMA Update
Rosa Gonzalez-Quevedo

US Industry Representative
Maria Apostolaros, JD, PharmD, MS, RPh


Speakers
avatar for Maria Apostolaros

Maria Apostolaros

Deputy Vice President, Science and Regulatory Advocacy, PhRMA, United States
Dr. Maria Apostolaros is currently a Senior Director of Science and Regulatory Advocacy at PhRMA, the US industry association representing the country’s leading innovative biopharmaceutical research companies devoted to discovering and developing medicines that enable patients to... Read More →
avatar for Robyn Bent

Robyn Bent

Director, Patient Focused Drug Development, OCD, CDER, FDA, United States
Robyn Bent is the director of CDER’s Patient-Focused Drug Development (PFDD) Program, an effort to systematically obtain patient input and facilitate the incorporation of meaningful patient input into drug development and regulatory decision making. Prior to joining FDA, Robyn held... Read More →
avatar for Juan Garcia-Burgos

Juan Garcia-Burgos

Head of Public and Stakeholders Engagement Department, European Medicines Agency, Netherlands
Juan García Burgos is a Qualified Medical Doctor from Autonoma University in Madrid, specialised in urology. Juan worked as a urologist surgeon at the Maranon hospital in Madrid. He joined the European Medicines Agency in 2002 and was responsible for coordinating the preparation... Read More →
RG

Rosa Gonzalez-Quevedo

Scientific Research Officer, European Medicines Agency, Netherlands
KH

Karin Hoelzer

Senior Director, Policy and Regulatory Affairs, NORD, United States
Dr. Karin Hoelzer directs Policy and Regulatory Affairs for the National Organization for Rare Disorders (NORD®). She works closely with pharmaceutical and biotech partners to ensure public policy supports innovative approaches and new treatments, and adequately incorporates patient... Read More →
avatar for Steffen Thirstrup

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands
Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Session