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EVENT DATE
Oct 2016
M T W T F S S
24252627282930
EXPO DATE
Oct 2016
M T W T F S S
24252627282930

Venue

Sheraton Boston Hotel 39 Dalton Street
Boston , MA 02199
USA
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Type: Indoor - Hotel

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

Sheraton Boston Hotel
B2B

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.

Don't wait to register for the FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials. You'll meet influential people and maximize your opportunities for success. Start now by accessing the information below.

EVENT CONTACTS


Peter Brown
FDAmap
20203 Goshen Rd, Suite 261
Gaithersburg, MD 20879
Boston, MA 02199
(410) 501-5777

Dr Mukesh Kumar

EVENT DETAILS

Primary Industry:
Clinical Pharmacology
Other Industries:
Clinical Pharmacology, Professional Healthcare
Audience:
Industry Professionals
Notes:
Attendee Statistics:
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