Animal Health Regulatory Affairs 101

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
• Entrepreneurs
• 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 and FDA

• How to avoid common problems

• How to open an INAD File and request fee waivers

• The veterinary approval process across FDA and USDA

• 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 the 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

Rob Hunter, Ph.D.

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.

Norm Brown

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.

All times below are in central time (CT).

8 a.m. | Welcome

8:15 a.m. | Background on Global Market
Rob Hunter, Ph.D.

8:45 a.m. | Introduction to Veterinary Drug Approval Process
Rob Hunter, Ph.D.

• FDA's jurisdiction, structure and relevant animal health centers
• Intro to the FDCA, AMDUCA, ADAA, MUMS and Guidance (GFI)
• VICH

9:30 a.m. | Break

9:45 a.m. | Overview of Veterinary Drug Development
Rob Hunter, Ph.D.

• Discovery/Acquisition
  • Intellectual property, patents and data exclusivity
• Approval process overview

10 a.m. | Approval Process: Chemistry Manufacturing and Controls
Rob Hunter, Ph.D.

• Chemistry, Manufacturing Controls (CMC)
  • Brief description of cGXP
  • API: name, structure, properties
  • API manufacturing
  • Clinical trial material
  • Final formulation

11:30 a.m. | Approval Process Continued: TASS and HFS
Rob Hunter, Ph.D.

• Target Animal Safety Studies (TASS)
  • Content and format
  • Monitoring and reporting adverse drug events

12:30 p.m. | Lunch

1 p.m. | Approval Process Continued: TASS and HFS (continued)
Rob Hunter, Ph.D.

• Human food safety
  • Analysis of drug residues
  • Toxicology studies
  • Residue chemistry

2 p.m. | Break

2:15 p.m. | Approval Process Continued: Effectiveness and Minor Technical Sections
Rob Hunter, Ph.D.

• Effectiveness
  • Dosage characterization
  • Substantial evidence (e.g. dose confirmation and clinical field studies)
  • Environmental impact
• 3 minor technical sections
  • Labeling
  • FOI
  • AOI
• Labeling 21 CFR requirements
• Freedom of Information (FOI)
• All Other Information (AOI)

4:15 p.m. | Animal Drug User Fees and Related Fee Waivers
Rob Hunter, Ph.D.

• Animal Drug User Fee Act (ADUFA) – Applies to innovators only
• Animal Generic Drug User Fee Act (ADGUF) – Applies to generic manufacturers
• ANADA sections
• Types of fee waivers and reductions

4:45 p.m. | Veterinary Feed and OTC Products
Rob Hunter, Ph.D.

• Animal fees
• Veterinary OTC drugs and nutritional supplements
• Veterinary medical devices

5:15 p.m. | Wrap-up Discussion

5:30 p.m. | Adjourn

All times below are in central time (CT).

8:30 a.m. | Welcome and Recap

8:15 a.m. | Non-Approval Related Considerations
Norm Brown

8:30 a.m. | Pharmacovigilance 
Rob Hunter, Ph.D.

9:00 a.m. | Major differences between USDA and FDA
Rob Hunter, Ph.D.

9:15 a.m. | Vaccine History and Principles of Immunology
Norm Brown

• History of vaccines
• Principles of immunology

9:30 a.m. | USDA's Role in Regulating Biologics
Norm Brown

• Virus Serum Toxins Act
• USDA CVB
• Federal laws, regulations and guidance documents

10:15 a.m. | Break

10:25 a.m. | Overview of Product Licensing Steps
Norm Brown

• Communications with USDA-CVB
• Initial licensing steps
• Additional studies required for licensing
• In-process licensing steps
• Final licensing steps

10:55 a.m. | Overview of Product Maintenance Compliance
Norm Brown

• Documents
  • General requirements
  • Company specific required documents
    • Facility documents
    • Product documents (OOP, SO and Labeling)
• Inspections
  • Types of inspections and categories
  • Your role in inspections

11:10 a.m. | Overview of Quality Management Systems (QMS)
Norm Brown

11:55 a.m. | Diagnostic Test Kits
Norm Brown

12:15 p.m. | Lunch Break

12:45 p.m. | Marketing and Promotional Compliance
Norm Brown

1:00 p.m. | Other USDA Topics
Norm Brown

• State registrations
• Jurisdictional issues
• Pharmacovigilance

1:45 p.m. | Wrap-up and Evaluation

2 p.m. | Adjourn