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CfPA-The Center for Professional Advancement, 90 Minute Accredited Online Training
October 15, 2014 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend
This online training will be of great benefit to regulatory compliance professionals working on DMF, NDA, IND or ANDAs. Regulatory affairs professionals, attorneys, project managers, and management professionals in small and mid-size manufacture operations are also encouraged to attend. Description
This course will be available On Demand: October 16, 2014
This 90-minute accredited training is designed to provide a complete understanding of the purpose of a Drug Master File and how it is used by FDA. Included will be a discussion of the user fees, why to file, the elements that need to be included in the DMF, and how to update or change that information. There will also be a discussion of when and how a DMF is reviewed and how that review can impact an NDA or ANDA that has a reference letter.
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Organized by:
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CfPA-The Center for Professional Advancement |
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Invited Speakers:
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Gary L. Yingling, Esq., Senior Attorney , Morgan, Lewis & Bockius
Gary Yingling is a senior attorney in Morgan Lewis’s FDA Practice in Washington, DC. He focuses his practice on issues involving the U.S. Food and Drug Administration and has also represented clients in matters involving the Drug Enforcement Administration, the Federal Trade Commission, and various states. His clients have included corporations, partnerships and individuals in matters involving pre-IND, IND and end of Phase II meetings, NDA submissions, ANDA applications, paragraph IV filings, REMS, OTC Monographs, labeling, importation, regulatory marketing strategy, recalls, seizures, and criminal matters. He is a co-editor of Good Clinical Practice which focuses on FDA-regulated clinical trials. He has also counseled on FDA pre-approval manufacturing and clinical site inspections, assisted with 483 responses and been involved in all aspects of drug regulation.
Mr. Yingling earned his J.D. from Emory University School of Law in 1968. Prior to attending law school, he practiced community pharmacy and is a registered pharmacist in Maryland and D.C. He earned his M.S. from Purdue University in 1966 and his B.S. from University of North Carolina in 1962. He served in the FDA Office of General Counsel for a number of years and received FDA’s Award of Merit for his work on the OTC Review.
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Deadline for Abstracts:
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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