Phase I Investigational Drug Products | USA Seminar 2018

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  • Published date: April 2, 2018
    • Salt Lake city, Utah, United States

Course "Different requirements for Phase I Investigational Drug Products: which GMPs apply since most Phase I drugs are exempt from full GMP requirements and what IND data requirements are necessary as a result?" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
In January 2006, FDA issued a final rule which specified that most pharmaceutical products (including biologics) produced for use in Phase I clinical trial studies were exempted from complying with GMP requirements, as defined in 21 CFR Part 211 under 21 CFR 210.2(c). Section 501(a)(2)(B) of the FD&C Act requires drugs, including IND products, to comply with cGMPs or if they are not manufactured in compliance with cGMPs, they are deemed adulterated. Based on this statutory requirement for manufacturers to follow GMPs, FDA issued cGMP regulations for drug and biological products in the Code of Federal Regulations (in 21 CFR parts 210 and 211). There are certain requirements in 21 CFR Part 211 that are directed at the commercial manufacture of products typically characterized by large, repetitive, commercial batch production and requirements as a result, are not appropriate to the manufacture of most investigational drugs used for phase I clinical trials. Based on these issues, application of cGMPs to Phase I investigational drug products was exempted from 21 CFR 211. However, based on statutory requirements as given in Section 505(i) of the FD&C Act, FDA issued regulations governing IND products in order to protect human subjects enrolled in clinical trials, specifically with regards to the chemistry, manufacturing and controls data submitted as part of IND applications for drugs or biological products.
Speaker
Stephanie Cooke
President/CEO, Cooke Consulting Inc.
Stephanie Cooke, is the President/CEO of Cooke Consulting, Inc. Stephanie uses her roughly 20 years of experience to provide global consulting services in various areas of Regulatory Affairs, Quality Assurance and validation for pharmaceutical, biological/biotech products, medical device, combination drug/device and nutraceutical firms.
Location: Salt Lake City, UT Date: May 10th & 11th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: Hilton Garden Inn Salt Lake City Airport 4975 Wiley Post Way, Salt Lake City, Utah, 84116, USA

Price:
Price: $1,295.00 (Seminar Fee for One Delegate)
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Until March 31, Early Bird Price: $1,295.00 From April 01 to May 7, Regular Price: $1,495.00
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