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Regulatory Policy Roundtable: Pharmaceutical Quality, Generics, Innovative Medicines
Session Chair(s)
Aaron Josephson, MS
Vice President & Head of Global External Relations, Samsung Bioepis, United States
Industry leaders will discuss how regulatory and industrial policy can support delivering quality-assured medicines to patients faster, how to assure pharmaceutical quality for innovative and generic medicines especially in light of new analytical technologies, and how to evaluate potential threats to quality in the context of benefit-risk and patient access.
Learning Objective : Define quality management maturity (QMM) and how the government is proposing to use it to improve the quality of medicines and resiliency of the supply chain; Identify policy solutions to quality challenges like nitrosamines, PFAS, and related impurities/chemicals; Understand the role of third parties like USP in defining quality standards; Comprehend policy ideas that enable earlier patient access to medicines without compromising quality
Speaker(s)
Aaron Josephson, MS
Vice President & Head of Global External Relations, Samsung Bioepis, United States
How to Integrate Quality Management Maturity into Regulatory Assessment and Oversight
Katherine Wilson, JD, MA
Head, Global Regulatory Policy and Intelligence, Viatris, United States
Global Landscape of Emerging Impurity and Chemicals Challenges
Kristin Willemsen, MS
Vice President, Scientific and Regulatory Affairs, Canadian Generic Pharmaceutical Association, Canada
Quality Policy Priorities of the Canadian Generic Industry
Brett Howard, JD, PHD
Senior Director, US Regulatory Policy, USP, United States
The Changing Pharmaceutical Quality Landscape – Pharmacopeial Perspective
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