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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|
|Primary Industry:||Clinical Pharmacology|
|Other Industries:||Clinical Pharmacology, Professional Healthcare|
|Cost to Attend:||$1099|
|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|
|Marketing Vehicles Allowed:||Call|
|Other Booth Sizes Available: n/a|
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