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 Protection Agency.
This seminar on veterinary medicine regulations will provide attendees with a comprehensive understanding of FDA’s veterinary drug approval process. 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 product approval
- The nature of shared jurisdiction over veterinary products in certain cases.
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.
- Analyze FDA’s rules governing chemistry, manufacturing and controls or CMC.
- Understand the various components of an animal field study to support product approval.
- 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 and advertising.
- 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.
Who will Benefit:
This course is designed for people tasked with developing and maintaining an animal health company’s product portfolio; and responsible for overseeing a company’s regulatory strategies. This includes individuals responsible for overseeing regulatory affairs, developing strategies for obtaining veterinary drug product approvals and those tasked with ensuring corporate compliance. Among others, this includes:
- 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
- Document control specialists
- Record retention specialists
- Legal Professionals
- Financial Advisors and Institutional Investors
- Consultants, Inspectors and cGxP Experts
Early bird seats are limited and based on first-come, first-serve.
Your registration fee includes the workshop, all course materials and lunch.
For discounts on multiple registrations, contact customer care at +1-1-888-771-6965.
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Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.
- 2 Attendees
- 3 to 6 Attendees
- 7 to 10 Attendees
- 10+ Attendees
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Checks should be payable to MetricStream Inc. (our parent company). and mailed to:
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Palo Alto, CA 94303
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Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @ email@example.com
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)
Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future GRC Seminars event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.
In the event GRC Seminars cancels the seminar, GRC Seminars is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
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After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.
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