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FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials — FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials
27 May 2017 - 28 May 2017 • Boston, United States
Manufacturing an investigational product for the initial pilot clinical trials could pose a considerable logistical and financial challenge to developers. The first-in-man and pilot clinical trials are usually conducted in very small number of healthy participants with lower doses primarily to establish safety and hence do not need a significant amount of investigational material. This workshop will present the current regulations, guidance documents and regulatory strategies available for manufacturing an early development stage product for Phase I and first-in-man clinical trials. Also discussed will be logistical issues with managing the supply of an early stage investigational product, and requirements for stability testing, storage and shipping, labeling, and documentations. Perspectives for different classes of products will be presented using case studies.
Peter Brown;     Phone: [410-501-5777];     Email:
Clinical Trials, GMP Phase 1, FDA GMP Regulations, FDA GMP Guidance
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