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Hilton Lac-Leamy

Nov 05, 2019 7:30 AM - Nov 06, 2019 3:15 PM

3 Boulevard du Casino, Gatineau, QC J8Y 6X4, Canada

DIA Annual Canadian Meeting

Session 2: Plenary: Patient Experience: What is it, Where are we now, and Where are we Going?

Session Chair(s)

Rania  Mouchantaf, PhD

Rania Mouchantaf, PhD

A/Executive Director, Marketed Pharmaceuticals Bureau, MHPD

Health Canada, Canada

Loretta  Del Bosco

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

Patient Involvement in the Development and Safe use of Medicines

Talia Lacroix, MPA

Health Canada, Canada

Senior Policy Analyst, Health Product and Food Branch

Meghana  Chalasani, MHA

Speaker

Meghana Chalasani, MHA

FDA, United States

Associate Director for Clinical Trial Innovation, Office of New Drugs, CDER

Dawn P. Richards, PhD

Speaker

Dawn P. Richards, PhD

Clinical Trials Ontario, Canada

Director, Patient and Public Engagement

Katherine M. Soltys, MD

Panelist

Katherine M. Soltys, MD

Health Canada, Canada

Director, Office of Clinical Trials, Pharmaceutical Drug Directorate

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