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Benefit-Risk Assessment and Management Across the Lifecycle

Review the key benefits-risk assessment methods and how to incorporate the patient perspective.

Authors

Rebecca  Noel, DrPH, MPH

Rebecca Noel, DrPH, MPH

Executive Director, Benefit-Risk Assessment, Eli Lilly, United States

Rebecca (Becky) Noel is currently the Global Leader for Benefit-Risk Assessment at Eli Lilly. Since joining Lilly, Becky has been extensively involved in leading the development of systematic approaches to benefit-risk assessment, both internally at Lilly and externally via the PhRMA Benefit-Risk Action Team (BRAT), the Innovative Medicines Initiative PROTECT project, the International Conference on Harmonization, and via multiple other forums.

Stephanie  Tcherny- Lessenot, MD, MPH, MSc

Stephanie Tcherny- Lessenot, MD, MPH, MSc

Head of Benefit-Risk Evaluation, Epidemiology & Benefit-Risk Evaluation, Sanofi, France

Stephanie Tcherny-Lessenot is a physician, public health specialist. She has been working over the past ten years in pharma companies on pharmacoepidemiological studies to support market access, pricing and risk management plans. Within Sanofi Global Pharmacovigilance & Epidemiology department, she supported registration and post-marketing referrals for CNS, multiple sclerosis and rare diseases drugs. She has also contributed to IMI projects PROTECT and WEB RADR.

Meredith  Yearsley Smith, PhD, MPA, FISPE

Meredith Yearsley Smith, PhD, MPA, FISPE

Fellow and faculty member, USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States

Meredith is a health services and implementation science researcher with + 20 yrs of experience in the pharmaceutical industry where she has held senior positions in drug safety, health economics and regulatory affairs. Currently, she is a Fellow of the Int. Society for Pharmacoepidemiology, and a faculty member at the Alfred E. Mann School of Pharmacy & Pharmaceutical Sciences at the University of Southern California. Meredith has been an invited participant in numerous risk management workshops and panels sponsored by the US FDA, and has served as a member of CIOMS IX Practical Approaches to Risk Minimisation for Medicinal Products, CIOMS XI Patient Involvement in the Development and Safe Use of Medicines and IMI-PREFER.

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