September 16, 2021

Veterinarian Daily News

Veterinarian Daily News

Online Seminar Veterinary Drug Approval Process and FDA Regulatory Oversight (September 16th-17th, 2021)

3 min read

DUBLIN, Aug 18, 2021 – (BUSINESS WIRE) – The Veterinary Drug Approval Process and FDA Regulatory Oversight conference has been added to ResearchAndMarkets.com offer.

This two-day interactive online seminar provides attendees with an understanding of the FDA’s 2021 approval process for veterinary drugs. The U.S. Food and Drug Administration’s (CVM) Center for Veterinary Medicine (CVM) is responsible for approving veterinary drugs for pets and food responsible -producing animals and other animal species.

This seminar covers the process of obtaining federal government approval to commercialize new veterinary drugs that are under the jurisdiction of the FDA and, briefly, animal products that are regulated by other federal agencies.

For example, animal vaccines, animal disease diagnostics, and some biological veterinary drugs 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, usually between 8 and 10 people, with plenty of opportunities to ask questions and discuss problems or challenges that the participants have experienced.

Learning goals:

The most important objectives of the seminar include learning:

  • How the US Food and Drug Administration (FDA) regulates veterinary drugs.

  • How the FDA’s Center for Veterinary Medicine is organized.

  • The process by which veterinary medicinal products are tested and approved.

  • How to open an Investigational New Animal Drug (INAD) file.

  • The various FDA user fees, what fee waivers are available, and how to apply for a fee waiver.

  • The various technical sections contained in a New Animal Drug Application (NADA).

  • What information is required to support product characterization, safety, and efficacy of target animals?

  • An overview of the FDA’s Chemistry, Manufacturing, and Controls (CMC) regulations.

  • The various components of a tier field study to support product approval.

  • How Pet Food, Veterinary Medicines, OTC Drugs, and Diet Supplements are Regulated in the United States

Who should attend:

The story goes on

This course is primarily aimed at people who are tasked with developing new veterinary drugs for an animal health company or a human pharmaceutical company. This includes those responsible for overseeing regulatory affairs, developing veterinary medicines, or evaluating new technologies or applications. These include:

  • New employees in the animal health industry

  • CRO professionals

  • Entrepreneurs who want to add value to their products

  • Regulatory experts

  • Compliance experts

  • US agents of foreign companies

  • Lawyers

  • Financial Advisers and Institutional Investors

Agenda:

DAY 01 (12:00 PM – 5:00 PM EDT)

Introduction to the approval process for veterinary medicinal products

  • Definitions

  • INAD / NADA technical sections

  • Some differences between the approval process for human and veterinary medicinal products

  • FDA organization and jurisdiction

  • Introduction to Federal Regulations (FD&CA, AMDUCA, ADAA, FDAMA)

  • FDA guidelines and other online resources

  • Discovery / Acquisition – Preliminary Patent Protection Concerns

  • INAD / NADA phase review

  • Meeting with CVM

  • Brief description of cGxP (GMP, GLP, GCP)

Development of the NADA Technical Sections

DAY 02 (12:00 PM – 5:00 PM EDT)

Development of the NADA Technical Sections (continued)

  • Target Animal Safety (TAS)

  • Food safety for humans

  • Ecological damage

  • labeling

  • Summary of Freedom of Information (FOI)

  • All other information (AOI)

Overview of Generic Veterinary Medicinal Products (JINAD)

Minor Use Minor Species (MUMS)

Marketing exclusivity and exclusive marketing rights

Veterinary drug usage fees and related exemptions

Animal feed, OTC drugs, food supplements, medical devices

USDA and EPA

Non-regulatory considerations

For more information on this conference, please visit https://www.researchandmarkets.com/r/sfvbg0

View source version on businesswire.com: https://www.businesswire.com/news/home/20210818005314/en/

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