FDA’s Current Thinking for Industry cGMPs for Phase 1 INDs (Pharmaceuticals Trai)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Feb 24, 2012 End Date/Time: Feb 24, 2012
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Description

The US FDA has issued a draft guidance document outlining a suggested approach to complying with current good manufacturing practice (CGMP) requirements for drugs intended soley in Phase 1 studies.With this guidance and an accompanying regulation, US FDA formally recognizes specific standards for the manufacture of small amounts of drug products for phase 1 studies and formulating an approach to cGMP compliance that is appropriate for the particular stage of drug development. This presentation will give an insiders insight into the the new guidance and regulation and discuss the rationale for such.

Venue

Online Event
2600 E. Bayshore Road
Palo Alto
California
United States
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