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Bethesda North Marriott Hotel and Conference Center

Sep 17, 2015 7:15 AM - Sep 18, 2015 4:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Patient Engagement in Benefit-Risk Assessment throughout the Life Cycle of Medical Products

Engage with patients, industry, and regulators to address the challenges of when and how to include patient perspectives in benefit-risk assessment of medical products.

Session 7: Equipping Patient Partners to Provide Input

Session Chair(s)

Richard  Hermann, DrMed, MD, MPH

Richard Hermann, DrMed, MD, MPH

Safety Science Physician, CMO Organization

AstraZeneca, United States

K. Kimberly  McCleary

K. Kimberly McCleary

Founder and Chief Executive Officer

The Kith Collective, LLC, United States

Patient partners have significant contributions to make in benefit-risk assessment and decision-making, and a clear understanding of the medical product life cycle process helps to enable their proactive involvement. Recognizing the unique and varied knowledge and experience of patient partners, this session will discuss model initiatives to provide knowledge resources for patient partners.

Speaker(s)

Marc M. Boutin, JD

Research-Ready Populations

Marc M. Boutin, JD

Novartis , Switzerland

Global Head of Patient Engagement and Advocacy

Richard  Klein

FDA Patient Education and Training Efforts

Richard Klein

GE2P2 Global Foundation, United States

Director, Expanded Access Programs & Policy, Former FDA, Patient Liaison

Sara  Loud, MBA, MS

Utilizing Technology: Online Patient Platforms

Sara Loud, MBA, MS

Accelerated Cure Project, United States

Chief Operating Officer

Panel  Q&A

Panel Q&A

United States

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