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Session 9A: API Starting Materials - Implementation
Session Chair(s)
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
Pharmaceutical Quality Senior Specialist, European Medicines Agency, Netherlands
Definition of Starting Materials for the Synthesis of the Active Substance - The EMA View <i>This presentation will be given via WebEx</i>
Michael Anthony McGuire
Team manager, Glaxosmithkline, United States
Science and the Supply Chain: Challenges in the Application of ICHQ11 Principles for the Selection and Justification of API Starting Materials
John Pavey, PHD
Director, Global Chemical Development, AstraZeneca, United Kingdom
Recent Approaches to Registered Starting Materials