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Session 2: Plenary: Patient Experience: What is it, Where are we now, and Where are we Going?
Session Chair(s)
Rania Mouchantaf, PhD
A/Executive Director, Marketed Pharmaceuticals Bureau, MHPD, Health Canada, Canada
Loretta Del Bosco
Director, Regulatory Affairs Quality Assurance Operations, AbbVie Corporation, Canada
Globally, patients are now invited to state their perspectives and preferences on new needed medicines and to provide input to regulatory benefit-risk assessments. Therefore, the importance of patient engagement is now recognized as a critical step throughout the lifecycle of a therapeutic product from drug development to their safe use once on the market. As a result regulators and other stakeholders are working toward ensuring that patient experiences are meaningfully captured. This includes consideration for engaging patients early on in trial design, endpoint development, clinical outcome assessment data (e.g., patient reported outcomes), as well as preferences on optimal design of the risk minimization tools. This session will provide various international and Canadian initiatives as they relate to this topic.
Learning Objective : At the conclusion of this session, participants should be able to:- Gain information on various ongoing international and Canadian initiatives as they relate to this topic
- Understand examples of when patient involvement contributed to a regulatory decision, including those that raise unanswered questions or potential gaps in our understanding on how and when to engage the patient
Speaker(s)
Talia Lacroix, MPA
Senior Policy Analyst, Health Product and Food Branch, Health Canada, Canada
Patient Involvement in the Development and Safe use of Medicines
Meghana Chalasani, MHA
Associate Director for Clinical Trial Innovation, Office of New Drugs, CDER, FDA, United States
Speaker
Dawn P. Richards, PhD
Director, Patient and Public Engagement, Clinical Trials Ontario, Canada
Speaker
Katherine M. Soltys, MD
Director, Office of Clinical Trials, Pharmaceutical Drug Directorate, Health Canada, Canada
Panelist
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