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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 9A: API Starting Materials - Implementation

Session Chair(s)

Scott  Coffey, PhD

Scott Coffey, PhD

Sr. Director CMC, Chorus and Global External R&D

Eli Lilly and Company, United States

API starting material selection and justification is a critical activity in the drug development and commercialization process. General principles for the selection of API starting materials are outlined in ICH Q11. The application of these guidelines, however, has varied from company to company, and interpretation of the guidelines by pharmaceutical companies and regulatory agencies has been inconsistent. This has led to frustration by both industry and regulatory agencies and can lead to delays in drug development timelines and to significant changes in supply chain strategies. This session will provide examples of the implementation of API starting material strategies, feedback from regulatory agencies, and a regulatory agency view on API starting materials. Time will be reserved for a panel discussion, and audience participation is highly encouraged.

Speaker(s)

Representative Invited

Definition of Starting Materials for the Synthesis of the Active Substance - The EMA View <i>This presentation will be given via WebEx</i>

Representative Invited

European Medicines Agency, Netherlands

Michael Anthony McGuire

Science and the Supply Chain: Challenges in the Application of ICHQ11 Principles for the Selection and Justification of API Starting Materials

Michael Anthony McGuire

Glaxosmithkline, United States

Team manager

John  Pavey, PhD

Recent Approaches to Registered Starting Materials

John Pavey, PhD

AstraZeneca, United Kingdom

Director, Global Chemical Development

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