The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) is responsible for the approval and monitoring of drugs intended for animals, including most cell-based animal drug products. CVM also has jurisdiction over animal feeds, pet food, food additives, pet treats and animal medical devices. However, FDA does not regulate all products intended for animal use. For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) and some flea and tick products are regulated by the Environmental Protection Agency.

This seminar on veterinary medicine regulations will provide attendees with an 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

Learning Objectives:

Upon completing this course on veterinary medicine regulations participants will:

  • Understand how the U.S. Food and Drug Administration (FDA) regulates veterinary drug products.
  • Understand how FDA’s Center for Veterinary Medicine (CVM) 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 a New Animal Drug Application (NADA).
  • Develop a deep understanding of what data is needed to support product characterization, target safety and effectiveness.
  • Gain general understanding of FDA’s rules governing chemistry, manufacturing and controls (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.
  • Learn how animal feed, veterinary devices, OTC drug products and nutritional supplements are regulated in the U.S.
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Who will Benefit:

This course is designed for people tasked with developing 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 veterinary drug products, evaluating new technologies or applications, 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
  • Legal Professionals
  • Financial Advisors and Institutional Investors
  • Consultants, Inspectors and cGxP Experts
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM to 4:30 PM PST)
  • Introduction to the Veterinary Drug Approval Process
    • Definitions
    • Overview of typical steps in veterinary drug development
    • INAD/NADA technical sections
    • Some differences between human and animal drug approval process
    • FDA organization and jurisdiction
      • FDA Centers relevant to Animal Health
    • Introduction to Federal Regulations (FD&CA, AMDUCA, ADAA, FDAMA)
    • FDA Guidance documents and other online resources
    • INAD/NADA Phased Review
      • Open an INAD File
      • Submit Early Information
      • Phased Review of Technical Sections
    • Meetings with CVM
    • Brief description of cGxP (GMP, GLP, GCP)
  • Developing the NADA Technical Sections
    • Chemistry, Manufacturing, Controls (CMC)
    • Product Characterization (required for stem cells and other cell-based products only)
    • Effectiveness – planning and conducting clinical field studies
    • Target Animal Safety (TAS)
    • Human Food Safety
    • Environmental Impact
    • Labeling
    • Freedom of Information (FOI) Summary
    • All Other Information (AOI)
Day 02(8:30 AM to 3:00 PM PST)
  • Overview of Generic Animal Drugs (JINAD)
    • CMC
    • Bioequivalence (Safety & Efficacy)
    • Human Food Safety
    • Labeling
  • Minor Use Minor Species (MUMS)
    • Designation
    • Determination
    • Indexing
  • Marketing Exclusivity & Exclusive Marketing Rights
  • Animal Drug User Fees and related waivers
  • Animal Feed, OTC Drugs, Supplements, Medical Devices
  • USDA & EPA
  • Non-Approval-Related Considerations
    • Extra-Label Drug Use
    • Compounding
    • Noncompliance and Enforcement
    • Pharmacovigilance
    • Post-approval submissions for CMC changes
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Mark A Hughes

Mark Hughes
Consultant, Hughes Veterinary Consulting

Dr. Mark Hughes, DVM, MS, has over 13 years of experience in veterinary drug product development and over 20 years of experience in university veterinary research, laboratory animal medicine, and development of in-vitro diagnostic tests. He has managed or contributed to clinical studies and regulatory submissions on the safety and effectiveness of veterinary drugs (including stem cells) for therapeutic treatments related to dermatology, cardiology, endocrinology, oncology, osteoarthritis, and infectious diseases. Through his part-time consulting business, Hughes Veterinary Consulting, he assists domestic and international biotech and pharmaceutical companies with the process of applying for regulatory approval of drug products for use in companion animals.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card

$1,499.00

(One Dial-in One Attendee)

February 16-17, 2023, Las Vegas, NV
(Registrations till January 31, 2023 - $1499)
(Registrations after January 31, 2023 - $1899)

$8,999.00

Group-Max. 10 Attendees

February 16-17, 2023, Las Vegas, NV
(Registrations till January 31, 2023 - $8,999)
(Registrations after January 31, 2023 - $10,999)



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Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% 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 training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without notice.
Offers:
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  • Testimonials

    See What People Say About Us

    Overall this training was very informative, Mark was able to adapt to the virtual training well. Mark did well in presenting the information and continually verifying that everyone was following. He encouraged input and participation. The only thing I may recommend for future virtual sessions is maybe some interactive slides ("test your understanding", etc.). I enjoyed the training and I definitely left with knowledge that will be beneficial.

    Regulatory and Quality Affairs Manager,

    EPiQ Animal Health

    The presenter for this seminar, Mark Hughes, clearly has a great depth of knowledge and experience with this subject matter. The notes are especially well done and documented and I believe the information shared in the seminar and the notes will be a great resource for us. Mark had many great examples and anecdotes from his experience that brought the material to life. Maybe at some point running through a scenario of drug development from the idea, to informational meetings with FDA/CVM, development of the protocol, pre-submission meetings with the FDA/CVM, that lays out the steps and timing for an example of the process, perhaps with and without MUMS designation.

    Clinical Trial Manager,

    STATKING Clinical Services

    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

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