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Hyatt Regency Bethesda

Apr 13, 2015 7:00 AM - Apr 15, 2015 12:00 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

CMC Workshop 2015

Session 8B: FDA/EMA QbD Pilot Program Update

Session Chair(s)

Ganapathy  Mohan, PhD

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

US FDA Regulatory Perspectives of the FDA/EMA QbD Pilot Program

Christine Moore, PhD

Organon & Co., United States

Executive Director, Global External Advocacy and Standards

Roger  Nosal, PhD

Industry Perspectives of the FDA/EMA QbD Pilot Program

Roger Nosal, PhD

Pfizer Inc, United States

Vice President, Head of Global CMC

Jean-Louis  Robert, PhD

EU Regulatory Perspectives of the FDA/EMA QbD Pilot Program

Jean-Louis Robert, PhD

Luxembourg

Former CHMP/CVMP QWP Chair

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