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Session 8B: FDA/EMA QbD Pilot Program Update
Session Chair(s)
Ganapathy Mohan, PHD
Head of External Affairs (Quality), Merck & Co., Inc., United States
Quality by Design (QbD) has become a way of life in the pharmaceutical industry in how we develop drugs. This was piloted in the early 2000s (around 2004-2005) by the US FDA and submissions were filed by sponsors for review and approval by the US FDA. In the years since the pilot program was started, a number of continuous improvements have been made to the understanding, expectations of regulators, and the implementation from the industry. However, the expectations from the regulators around the world have not been fully harmonized. In 2011, FDA and EMA announced the joint QbD Pilot Program which would help to bring the review process closer than before between the two regulatory bodies.
This session will have leading regulators, from Europe and the United States, and an industry speaker share their perspectives on this topic and provide an update on progress made to date. Presentations will be followed by panel discussions.
Speaker(s)
Christine Moore, PHD
Executive Director, Global External Advocacy and Standards, Organon & Co., United States
US FDA Regulatory Perspectives of the FDA/EMA QbD Pilot Program
Roger Nosal, PHD
Vice President, Head of Global CMC, Pfizer Inc, United States
Industry Perspectives of the FDA/EMA QbD Pilot Program
Jean-Louis Robert, PHD
Former CHMP/CVMP QWP Chair, Luxembourg
EU Regulatory Perspectives of the FDA/EMA QbD Pilot Program