DUBLIN – The «The Veterinary Drug Approval Process and FDA Regulatory Oversight» conference has been added to ResearchAndMarkets.com’s offering.
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.
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.
Time: 12:00 PM – 05:00 PM EDT
Who Should Attend:
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
Agenda:
DAY 01 (12:00 PM – 05:00 PM EDT)
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 (12:00 PM – 05:00 PM EDT)
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