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

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.

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Conference/Event Dates: 10/27/2016 - 10/28/2016
Conference/Event Hours: 8am-4pm EST
Classification: B2B
Primary Industry: Clinical Pharmacology
Other Industries: Clinical Pharmacology, Professional Healthcare
Cost to Attend: $1099
Audience: Industry Professionals
Venue: Sheraton Boston Hotel
Venue Phone: (617) 236-2000
Venue Type: Indoor - Hotel

Booth Size Booth Cost   Available Amenities
Please Contact FDAmap for Additional Information   Electricity: n/a
  Water: n/a
  Generator: n/a
  Marketing Vehicles Allowed: Call
Other Booth Sizes Available: n/a

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