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When
Dec 2, 2008 (Tuesday) to
Dec 3, 2008 (Wednesday)
Where
Who
No performers specified
What
Event Name: Barnett International: Drug Approval Process Event Date(s): Tuesday, December 02, 2008 to Wednesday, December 03, 2008 Event Location: Embassy Suites Hotel Chicago-Dow...
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Event details: Barnett International: Drug Approval Process
Description
Event Name: Barnett International: Drug Approval Process
Event Date(s): Tuesday, December 02, 2008 to Wednesday, December 03, 2008
Event Location: Embassy Suites Hotel Chicago-Downtown/Lakefront, Chicago, Illinois, U.S.A.
Cost: $1,695
Description: This course provides a comprehensive approach to the preparation and submission of documents to the FDA for approval of drug products. Participants receive a foundation of knowledge about the drug approval process, submission preparation, and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research are provided, as well as information on the structuring and assembly of INDs, NDAs, and post-approval documents. Information on maintaining on-going relationships with the FDA is also discussed. The course enables regulatory affairs professionals to prepare concise documents, provide the FDA with necessary information, and obtain rapid product approval.
Sponsor: Barnett International
Host Company: Barnett International
Contact Information: Phone: 215-413-2471
Fax: n/a
Email: n/a
Event Date(s): Tuesday, December 02, 2008 to Wednesday, December 03, 2008
Event Location: Embassy Suites Hotel Chicago-Downtown/Lakefront, Chicago, Illinois, U.S.A.
Cost: $1,695
Description: This course provides a comprehensive approach to the preparation and submission of documents to the FDA for approval of drug products. Participants receive a foundation of knowledge about the drug approval process, submission preparation, and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research are provided, as well as information on the structuring and assembly of INDs, NDAs, and post-approval documents. Information on maintaining on-going relationships with the FDA is also discussed. The course enables regulatory affairs professionals to prepare concise documents, provide the FDA with necessary information, and obtain rapid product approval.
Sponsor: Barnett International
Host Company: Barnett International
Contact Information: Phone: 215-413-2471
Fax: n/a
Email: n/a
Cost
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