GMP Phase I — FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials

Expired
Dates : 24 October 2019 » 25 October 2019

Place : Boston
United States

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Organizer :

Topic : Health and Medicine; Regulation in Medicine and Pharmacology
Engineering and Technology; Health and Medicine;
Keywords: Manufacturing, Medicine
Description :

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. The US FDA allows developers to test early stage investigational products under relaxed GMP requirements. The manufacturing requirements for early stage clinical trials are designed to assure adequate quality of the investigational product being tested without the excessive regulatory burden of full-scale GMP manufacturing. 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.


GMP Phase I — FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials to be held in Boston, United States between 24 October 2019 and 25 October 2019. It covers specific areas of Health and Medicine such as Regulation in Medicine and Pharmacology. Visit the website of the conference for more detailed information or contact the organizer for specific questions.
Add to calendar 2019-10-24 2019-10-25 Europe/London GMP Phase I — FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials https://www.sciencedz.net/en/conference/62782-gmp-phase-i-fda-rsquo-s-gmp-expectations-for-phase-i-and-first-in-man-clinical-trials Boston - United States

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Conferences and seminars in Health and Medicine in 2019
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