The Veterinary Drug Approval Process and FDA Regulatory Oversight

Instructor: Rob Hunter
Product ID: 705546
  • Duration: 90 Min
Products for animal health commercialization follow a structured progression from initial concept through to regulatory approval. Typically, products are developed for use in either food animals or companion animals. These can be for the intention of disease intervention, productivity enhancement or improvement in a quality of life capacity. The animal health industry is a regulated industry, meaning that a government agency is responsible for oversight of products, both pre- and post-approval. There are three primary US government agencies that ensure quality, safety and effectiveness for the approval of new products and post-marketing compliance.
Purchase option for this webinar is currently unavailable. Please contact our Customer Care for more info.

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

Why Should You Attend:

This webinar provides an animal health industry perspective of the veterinary drug development and approval process. It is not intended to be a comprehensive, in-depth regulatory resource but rather will provide the attendee with a general overview of the industry and the drug-commercialization process. Similar to the human pharmaceutical industry, innovation is essential to the existence of animal health companies. It may take 5–15 years and, perhaps, more than $100 million to advance an animal health drug from initial concept to market. The company has a minimum of 17 years from the time a patent is issued to recoup its development costs, therefore, the urgency required to move a candidate through the pipeline is obvious. The company may be able to extend that patent time by patenting novel formulations, uses or production processes.

Learning Objectives:

  • The types of markets and products that comprise the animal health pharmaceutical business
  • The goal is to advance a drug candidate through the process, usually beginning with product concept and ending with completion of studies to support a regulatory review. This is illustrated by the example of how a candidate molecule proceeds through the numerous studies needed to demonstrate quality, safety and effectiveness with the goal of a regulatory approval for the treatment or control of bovine respiratory disease
  • A description of the US FDA Center for Veterinary Medicine submission components included in a new animal drug application data package is provided
  • With the One Health Initiative, there may be more overlap between animal products and human-use products targeted to infectious disease
  • It is foreseeable that some of studies required for the approval of a new animal drug in the USA may be further harmonized with those required in other regions. New regulations will be necessary to address the new interventions that currently do not fit within the existing paradigm

Areas Covered in the Webinar:

  • Phase of the process where studies are conducted to determine whether a new chemical entity can be registered
  • Pivotal studies to support the approval of a new chemical entity are conducted and submitted to the regulatory authority
  • Veterinary drug approval: Process by which a new chemical entity is approved by a regional regulatory authority

Who Will Benefit:

  • Personnel new to the Animal Health Industry
  • CRO professionals
  • Entrepreneurs looking to add value to their products
  • Financial Advisors and Institutional Investors
  • Consultants, Inspectors and cGxP Experts
Instructor Profile:
Rob Hunter

Rob Hunter
Drug Development Specialist, One Medicine Consulting

Rob Hunter has 20+ years of veterinary and human drug development experience with NASA, Pfizer, Elanco, Parnell, and Provetica. He has contributed to the approvals for Revolution®, Dectomax®, Ovugel®, and Pulmotil®, with others currently in development or under regulatory review. Internationally recognized subject matter expert on pharmacokinetics, antimicrobial PK/PD, interspecies allometry, drug metabolism, bioequivalence, and tissue residues/human food safety along with corresponding bioanalytical support. Dr. Hunter has served on and chaired several AHI committees and represented the U.S. veterinary pharmaceutical industry on the VICH bioequivalence expert committee. He has represented various companies at CVM/FDA, EMA/CVMP, APVMA, VDD (Canada), NVQRS/QIA (South Korea), Thailand FDA, NVAL (Japan), Ministry of Agriculture (Vietnam), and IVDC (China) regarding specific products, issues, and/or policies.

Follow us :

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed