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Why, When, and How Should Patients Be Involved in the Benefit-Risk Assessment of Medicines?

Track:
Regulatory Affairs and Submissions

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

Session Number:
387

Room Number:
6D

Level:
Intermediate

Type:
Session

Title:
Why, When, and How Should Patients Be Involved in the Benefit-Risk Assessment of Medicines?

Chair(s):
Stuart Walker, PhD
Founder
Centre For Innovation In Regulatory Science (CIRS), United Kingdom

Description:
Patients’ perspective on benefits and harms is critical to the development and review of medicines. The challenge for agencies, companies and patients is how and when this should occur. Possible solutions will be presented.

Learning Objective(s):
Discuss how companies and agencies engage with patients to determine the benefit-risk assessment of medicines; Describe how patients and patient advocacy groups would like to be involved in decision making; Compare and contrast the differences in each stakeholder’s perspective on patients’ involvement.

Presentation(s) & Speaker(s):
EMA Perspective
Hans-Georg Eichler, MD, MSc
Senior Medical Officer
European Medicines Agency, European Union, United Kingdom

FDA Perspective
John J. Whyte, MD, MPH
Director, Professional Affairs and Stakeholder Engagement, OCD, CDER
FDA, United States

Patient Perspective
Durhane Wong-Rieger, PhD, MA
President and Chief Executive Officer
Canadian Organization For Rare Disorders (CORD), Canada