Conferences  >  Medicine & Healthcare  >  Translational Medicine, Clinical Trials  >  United States

Select a location
1
Phase I and First-in-Man Clinical Trials — FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials
20 Jul 2023 - 21 Jul 2023 • Washington DC, United States
Organizer:
FDAMap
Abstract:
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.
Topics:
FDA clinical Trials Clinical Studies Clinical Research Clinical Operations Clinical Development GMP FDA Compliance FDA Regulations
Event listing ID:
1561407


Conference-Service.com offers, as part of its business activities, a directory of upcoming scientific and technical meetings. The calendar is published for the convenience of conference participants and we strive to support conference organisers who need to publish their upcoming events. Although great care is being taken to ensure the correctness of all entries, we cannot accept any liability that may arise from the presence, absence or incorrectness of any particular information on this website. Always check with the meeting organiser before making arrangements to participate in an event!

No tracking | No pop-ups | No animations
Last updated: 9 June 2023