Choose a Purchase Options


€1.295

One Dial-in One Attendee - Live + 6 month Access

You get one log-in for the live virtual seminar for one participant & On Demand Recorded Access for 90 days , presentation materials , Certificate and the opportunity to ask questions by phone and email. On Demand Recorded Access for 30 days is included .

€3.995

Group-Max. 10 Attendees - Live + 12 month Access

You get Group log-in for the live virtual seminar for 10 participants, presentation materials , Certificate and the opportunity to ask questions by phone and email. On Demand Recorded Access is Included for 90 days for the Group.

€1.895

Recorded Access Group

You'll have 12 month access to group for an archived recording of the entire 2 day virtual seminar including the Q&A period. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

Course Description

This two-day interactive seminar online will provide attendees with an understanding of FDA’s veterinary drug approval process in 2021. The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) is responsible for the approval of veterinary drug products intended for family pets, food-producing animals, and other animal species. This seminar will cover the process for obtaining federal government approval for marketing new animal drug products that are under the jurisdiction of the FDA, and also briefly covers animal products that are regulated by other federal agencies. For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agriculture, and some flea and tick control products are regulated by the Environmental Protection Agency.

The group size is small, generally between 8 and 10 people, with plenty of opportunities to ask questions and discuss issues or challenges that the attendees have experienced.

Agenda

DAY 01

Introduction to the Veterinary Drug Approval Process

  • Definitions
  • 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
  • Discovery/Acquisition - Preliminary Patent Protection Concerns
  • 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)
  • Effectiveness
  • The 7 Major Phases of Clinical Field Studies

DAY 02

Developing the NADA Technical Sections (continued)

  • Target Animal Safety (TAS)
  • Human Food Safety
  • Environmental Impact
  • Labeling
  • Freedom of Information (FOI) Summary
  • All Other Information (AOI)

Overview of Generic Animal Drugs (JINAD)

  • Submissions - ANADA sections
  • CMC
  • Bioequivalence (Safety & Efficacy)
  • Human Food Safety
  • Labeling

Minor Use Minor Species (MUMS)

  • Designation
  • 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

Learning Objectives:

Key goals of the seminar will include learning:

  • How the U.S. Food and Drug Administration (FDA) regulates animal drug products.
  • How FDA’s Center for Veterinary Medicine is organized.
  • The process by which veterinary drug products are reviewed and approved.
  • How to open an Investigational New Animal Drug (INAD) File.
  • The FDA’s various user fees, what fee waivers are available, and how to request a fee waiver.
  • The various technical sections included in a New Animal Drug Application (NADA).
  • What information is needed to substantiate product characterization, target animal safety and effectiveness.
  • An overview of FDA’s rules governing chemistry, manufacturing and controls (CMC).
  • The various components of an animal field study to support product approval.
  • How animal feed, veterinary devices, OTC drug products and nutritional supplements are regulated in the U.S.

Who will Benefit

This course is designed primarily for people tasked with developing new animal drugs for an animal health company or a human pharmaceutical company. This includes individuals responsible for overseeing regulatory affairs, developing veterinary drug products, or evaluating new technologies or applications. 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
Karl M. Nobert FDA Industry Expert


Faculty Karl M. Nobert (25+ yrs exp)

  • Senior Counsel

Michael Best & Friedrich LLP - USA

Karl focuses his practice in FDA Regulatory law, representing U.S. and international clients in the food and drug industries with regard to pharmaceuticals and OTC drugs, biologics, medical devices, food and beverages including dairy products, cosmetics, vitamins and dietary supplements, and veterinary products.

He has particular experience in the areas of prescription drugs and regenerative medicine, and has counseled numerous clients seeking FDA approval for Rx drugs and cellular-based products to treat both humans and animals.

Our Past Seminar Testimonial


The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )

Tracey Kessler ( Director of R&D) CEL-SCI Corporation

I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals