Animal Health Regulatory 101
8:30 a.m. to 4:30 p.m. | Nov. 13
8:30 a.m. to 4:30 p.m. | Nov. 14
Kansas State University Olathe campus
22201 W. Innovation Drive, Olathe, KS
The U.S. Food and Drug Administration's Center for Veterinary Medicine, or FDA/CVM, is responsible for the approval of veterinary drug products intended for both family pets and food-producing animals. However, FDA does not regulate all products intended for animal use. Jurisdiction over animal products — including licensed biologics, such as vaccines — is shared with other federal agencies.
For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agriculture's Animal and Plant Health Inspection Service, or APHIS, and products such as flea and tick collars are regulated by the Environmental Protection Agency, or EPA. This makes navigating the regulatory space a bit confusing for people new to the industry or who have worked in the area of human drug development.
This workshop on veterinary medicine regulations will provide attendees with an understanding of veterinary drug approval processes. This two-day interactive course will cover a series of learning objectives.
This course will assist with connecting EMA, APVMA and VDD Animal Health drug registration requirements to CVM/FDA. It will help current international regulatory affairs personnel relate and understand the similarities and differences between non-US and US regulatory bodies.
This workshop is designed for people tasked with developing and maintaining an animal health company's product portfolio and involved with a company's regulatory strategies. This includes individuals involved with regulatory affairs, veterinary product development, conducting due diligence for product or company acquisitions, those tasked with ensuring corporate compliance, and members of investment companies working to learn about the industry. Among others, this includes:
- Personnel new to the animal health industry
- Contract Research Organization (CRO) and Contract Development and Manufacturing Organization (CDMO) employees
- Regulatory agents
- U.S. agents of foreign corporations
- Process owners
- Record retention specialists
- Legal professionals
- Financial advisors and institutional investors
- Consultants, inspectors and cGxP experts and trainers
Upon completing this course on veterinary medicine regulations, participants will have learned:
The nature of jurisdiction over veterinary products between USDA, FDA and EPA
How to avoid common problems
How to open an INAD File and request fee waivers
The veterinary approval process across FDA, USDA and EPA
Various sections of a New Animal Drug Application (NADA – pioneer products) and Abbreviated NADA (ANADA – generic products)
A working knowledge of the major and minor technical sections included within aan FDA/CVM NADA and/or ANADA
Strategies and plans for navigating the FDA/CVM approval process
How to avoid common problems
ADUFA and AGDUFA fee waivers, including how to obtain these waivers
$1,200 per person.
The program fee includes:
- Light breakfast, lunch and afternoon refreshments
- Program materials in hard copy and e-formats
- Certificate of attendance from an accredited university
Seminar Instructor 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®, Aviax®, Doxidyl™, A180®, tylosin, Micotil®, Ovugel®, Kexxtone®, ractopamine, Experior™, Posilac® and Pulmotil®, with others currently in development or under regulatory review.
Hunter is an 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.
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. He is the current President of the American Academy of Veterinary Pharmacology and Therapeutics.
Seminar Instructor Norm Brown has 35 years of veterinary vaccine regulatory and quality experience with companies including Boehringer-Ingelheim Animal Health, Merck Animal Health, Diamond Animal Health and Mallinckrodt Veterinary.
Brown is an experienced leader with a diverse background and a customer-oriented approach. His background specifically includes regulatory and compliance resolution, new product registration, product complaint resolution, international registration, system critique and continuous improvement implementation.
Brown graduated from University of Nebraska with an B.S. in Microbiology and an M.S. in Veterinary Services.
|8 a.m. | Registration and Refreshments|
|Part 1: Introduction to Veterinary Drug Approval Process|
• FDA's jurisdiction and Center's relevant to Animal Health
• Specifics of CVM
• Intro to the FDCA, AMDUCA, ADAA, MUMS, etc., and guidance (GFI)
|Part II: Overview of Veterinary Drug Development|
• Brief Description of cGxP (GMP, GLP and GCP)
|Part III: Approval Process: Chemistry, Manufacturing Controls, Environmental Impact and Managing Clinical Trials|
• Target Animal Safety
• Human Food Safety
• Environmental Impact
• Labeling 21 CFR requirements
|4:30 p.m. | End of Day 1|
|8 a.m. | Networking and Refreshments|
|Part IV: Animal Drug User Fees and Related Fee Waivers|
• Veterinary Drug User Fees and Fee Reductions and Waivers
|Part V: Introduction to FDA's Regulation of Veterinary Feed and Veterinary Medical Devices|
• Animal Feed
• Veterinary Medical Devices CPG 655.100
|Part VI: Non-Approval-Related Considerations|
• Extra-Label Drug Use
• Noncompliance and Enforcement
|Part VII: USDA (CVB, APHIS, FSIS) and EPA|
• USDA's Animal and Plant Health Inspection Service
• State Registrations
|4:30 p.m. | End of Day 2/Workshop|