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Current Initiatives on Patient Involvement in the Medicinal Product Lifecycle: CIOMS XI
Session Chair(s)
Judith Zander, MD
Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER
FDA , 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)
An Introduction to CIOMS and the CIOMS XI Initiative on Patient Involvement in the Medicinal Product Lifecycle
Hervé Le Louet, DrMed, DrSc, MD, PhD, MS
CIOMS, Switzerland
President
FDA Perspective
Theresa Mullin, PhD
FDA, United States
Associate Center Director - Strategic Initiatives, CDER
The Role of Patients in Drug Development and Lifecycle Use
Marc M. Boutin, JD
Novartis , Switzerland
Global Head of Patient Engagement and Advocacy
An Overview of the CIOMS XI Initiative
Kerry Leeson-Beevers
Alström Syndrome UK, United Kingdom
National Development Manager
Using Patient Data to Evaluate the Benefits and Risks of Medicines
Meredith Smith, PhD, MPA, FISPE
Evidera, Inc, United States
Senior Director, Implementation Science Pillar Lead
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