Time: May 10, 2018 at 9am to May 11, 2018 at 6pm
Location: Hilton Garden Inn Salt Lake City Airport
Street: 4975 Wiley Post Way
City/Town: Salt Lake City
Website or Map: https://www.globalcompliancep…
Event Type: seminar
Organized By: John Robinson
Latest Activity: Mar 22, 2018
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.
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.
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: $1,295.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*
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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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