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AAVPT Veterinary Drug Regulatory Life Cycle Course Brochure

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Cover of AAVPT Veterinary Drug Regulatory Life Cycle Course Brochure 

Feb. 28—Mar. 4, 2011

The American Academy of Veterinary Pharmacology and Therapeutics (AAVPT) is announcing the Veterinary Drug Regulatory Life Cycle Course (VDRLC) that will be held at the Bolger Center, Potomac, MD from February 28 to March 4, 2011. Registration that was scheduled to start Monday, November 8th at 1 pm EST is delayed due to technical difficulties (AAVPT is using a web-based registration system). The new date for the start of registration is Wednesday, November 10th at 1 pm EST. Also, please note that registration will close promptly on December 8th at 11 pm EST. Registration is limited to 100 participants, so please sign up early.

To Register:

http://a3.acteva.com/orderbooking/go/aavptdisclaimer icon
The VDRLC course will provide a comprehensive overview of FDA CVM regulatory processes for new animal drug approvals and post-approval surveillance/compliance of marketed drugs.

This week-long course covers current policies, procedures, and standards across all technical sections of the drug approval process, and all aspects of the veterinary drug life-cycle. Attendees will learn about CVM’s organization and activities, and interact with CVM scientists across various offices and divisions.

Course content is targeted to industry and academic stakeholders interested in understanding the regulatory science of veterinary drug development. Scientists in all areas of drug research and development, manufacturing and clinical testing may all benefit from taking this course.

Program:

http://www.aavpt.org/documents/LifeCycleAgendaDraft.pdfdisclaimer icon

Monday, February 28, 2011
Welcome
CVM Overview
CVM Regulated Products
Intro to Course, Drug Approval Philosophy
Pre-Approval Process
Chemistry, Manufacturing, and Controls
Question Based Review
Pre-Approval GMP Inspections

Tuesday, March 1, 2011
Dosage Characterization
Effectiveness Overview
Effectiveness: Statistical Overview
Effectiveness Data Evaluation
Target Animal Safety Overview
Safety: Statistical Overview
Safety Data Evaluation

Wednesday, March 2, 2011
Abuse Liability
Human and Microbial Food Safety
Residue Chemistry and Violative Residues
Environmental Safety
Labeling, Freedom of Information
New Animal Drug Applications
Generics

Thursday, March 3, 2011
Minor Use Minor Species
Medicated and Non-Medicated Feeds
Compliance, Inspections, and Recalls
Post-Approval Reporting Requirements
Drug Listing and Registration
Preventing Medical Errors
Post-Approval Labeling, Advertising, and Promotions

Friday, March 4, 2011
CVM Research
Biotechnology
Public Input

Any questions about the course, please contact:

Dr. Sanja Modric, AAVPT President-elect
FDA Center for Veterinary Medicine
7500 Standish Place, Rockville, MD 20855
sanja.modric@fda.hhs.gov
Phone: 240-276-8339
Fax: 240-276-8350