The Veterinary Drug Approval Process and FDA Regulatory Oversight (com) A
At
Kansas City
For more information: https://www.eventbrite.com/e/international-conference-on-veterinary-animal-sciences-gic-as-tickets-53705080341
Kansas City, MO
DESCRIPTION
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The Veterinary Drug Approval Process and FDA Regulatory Oversight
The U.S. Food and Drug Administration’s Center for Veterinary Medicine or CVM is responsible for the approval of veterinary drug products intended for both family pets and food-producing animals.
However, FDA does not regulate all products intended for animal use. Jurisdiction over animal products including licensed biologics such as vaccines is shared with a number of other federal agencies.
Premarket approval process
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Various sections of a New Animal Drug Application
Strategies for navigating the FDA approval process and for expending product approval
The nature of shared jurisdiction over veterinary products in certain cases
For more information: https://www.eventbrite.com/e/international-conference-on-veterinary-animal-sciences-gic-as-tickets-53705080341
Learning Objectives:
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Upon completing this course on veterinary medicine regulations participants will:
Understand how the U.S. Food and Drug Administration regulates veterinary drug product.
Understand how FDA’s Center for Veterinary Medicine is organized.
Discuss the process by which veterinary drug products are reviewed and approved.
Learn how to open an INAD File and request fee waivers.
Obtain a working knowledge of various sections included within an NADA.
Develop a deep understanding of what is needed to substantiate product characterization, target safety and effectiveness.
ect
Who will Benefit:
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Personnel new to the Animal Health Industry
CRO professionals
Entrepreneurs looking to add value to their products
Regulatory professionals
Compliance professionals
U.S. Agents of Foreign Corporations
Process owners
Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If your company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
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For more information: https://www.eventbrite.com/e/international-conference-on-veterinary-animal-sciences-gic-as-tickets-53705080341
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