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Patient Voice in Decision Making: How Are Regulators Making This Work?

Track:
Public Policy/Health Care Compliance/Law

Day & Time:
June 18, 3:30PM - 5:00PM (Pacific Standard Time)

Session Number:
392

Room Number:
9

Level:
Intermediate

Type:
Forum

Title:
Patient Voice in Decision Making: How Are Regulators Making This Work?

Chair(s):
Eric Gascho
Director, Government Affairs
National Health Council, United States

Description:
Bringing the patient’s voice into decision making has allowed regulators to understand the real-life impact of regulatory decisions. It has also proven to enrich the quality of the scientific opinion while building trust in the regulatory process. This forum will discuss the main challenges the regulators are confronted with, which include the difficulty in identifying individuals with day-to-day experience of the disease and its therapeutic environment as well as the need to guarantee the independence of their views.

Learning Objective(s):
Identify challenges regulators face trying to bring the patient's voice into the decicion-making process.

Presentation(s) & Speaker(s):
Patient’s Voice in Decision Making: US Regulatory Perspective
James E. Valentine, JD
Associate
Hyman, Phelps & McNamara, P.C., United States

Patient Perspective
Eric Gascho
Director, Government Affairs
National Health Council, United States

Patient’s Voice in Decision Making: The EMA Model
Isabelle Moulon, MD
Head of Medical Information
European Medicines Agency, European Union, United Kingdom

How to Build Up Capacity of Patient Experts, Advocates, and Health Interested Citizens? The EUPATI Project
Jytte Lyngvig, PhD
Senior Vice President and Managing Director, DIA EMEA
DIA Europe, Middle East and Africa, Switzerland