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Current Initiatives on Patient Involvement in the Medicinal Product Lifecycle: CIOMS XI
Session Chair(s)
Judith Zander, MD
, Safety Strategy Consulting LLC, United States
The forum will cover latest developments on CIOMS XI from the perspective of patients, regulators, and industry. Current thinking in more closely involving patients throughout the medicines lifecycle will be presented and audience feedback sought. Join the Clinical Safety & Pharmacovigilance Community for a follow up Round Table discussion on Tuesday, June 25, 2:00-3:00PM in the DIA Community Zone 1, Sails Pavilion.
Learning Objective : Discuss the latest developments in patient involvement and engagement in the medicinal product lifecycle from development to post-marketing, pharmacovigilance and risk management; Describe current progress of the CIOMS XI WG in terms of involving patients and patient groups or associations more closely with medicines addressing medical needs.
Speaker(s)
Hervé Le Louet, DrMed, DRSc, MD, PhD, MS
President, CIOMS, Switzerland
An Introduction to CIOMS and the CIOMS XI Initiative on Patient Involvement in the Medicinal Product Lifecycle
Theresa Mullin, PhD
Associate Center Director - CDER, FDA, United States
FDA Perspective
Marc M. Boutin, JD
Global Head of Patient Engagement and Advocacy, Novartis , Switzerland
The Role of Patients in Drug Development and Lifecycle Use
Kerry Leeson-Beevers
National Development Manager, Alström Syndrome UK, United Kingdom
An Overview of the CIOMS XI Initiative
Meredith Yearsley Smith, MPA, FISPE
Fellow and faculty member, USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States
Using Patient Data to Evaluate the Benefits and Risks of Medicines
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