|[August 19, 2014]
Research and Markets: The Veterinary Drug Approval Process and FDA Regulatory Oversight: 2-Day In-Person Seminar - 18-19th September 2014, Chicago
DUBLIN --(Business Wire)--
Research and Markets (http://www.researchandmarkets.com/research/r28rzf/the_veterinary)
has announced the addition of the "The
Veterinary Drug Approval Process and FDA Regulatory Oversight: 2-day
In-Person Seminar" conference to their offering.
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. Not all
products intended for animal use are regulated by FDA. Jurisdiction over
animal products including licensed biologics such as vaccines is shared
with a number of other federal agencies. For example, animal vaccines,
animal disease diagnostic devices and some animal biologics are
regulated by the U.S. Department of Agriculture's Animal and Plant
Health Inspection Service or APHIS; and products such as flea and tick
collars are regulated by the Environmental Prtection Agency.
This seminar on veterinary medicine regulations will provide attendees
with a comprehensive understanding of FDA's veterinary drug approval
This two day interactive course will cover:
- Premarket approval process
- Various sections of a New Animal Drug Application
- Strategies for navigating the FDA approval process and for expending
- The nature of shared jurisdiction over veterinary products in certain
Upon completing this course on veterinary medicine regulations
- 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
- 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.
- Analyze FDA's rules governing chemistry, manufacturing and controls or
- Understand the various components of an animal field study to support
- Discuss the difference between FDA's various user fees and fee waivers.
- Identify the elements of an FDA compliant label.
- Develop a corporate compliance strategy covering labeling, marketing
- Problem solving methods to mitigate regulatory enforcement risks.
- Explain how jurisdiction is split between various Federal agencies in
a certain cases.
- Learn how animal feed, veterinary devices, OTC drug products and
nutritional supplements are regulated in the U.S.
For more information visit http://www.researchandmarkets.com/research/r28rzf/the_veterinary
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