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K-State Olathe

K-State Olathe
22201 W. Innovation Dr.
Olathe, KS 66061-1304

913-541-1220
913-541-1488 fax
olatheinfo@k-state.edu

Animal Health Regulatory 101 


An Introductory Course on the Regulatory Aspects of Animal Drug, Vaccine and Pesticide Development


Nov. 13-14 
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

 

Course Description

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.

 

Register now

 



Who will Benefit?

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


Learning Objectives

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

 


 
Cost

Individual

$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

Group

Group discounts are available for two or more employees per company. Contact Angela Buzard at abuzard@ksu.edu or 913-307-7340 to obtain discounts codes for a group.

 

Register now

 


Hotel Accommodations

A discounted hotel block is available at the Holiday Inn and Suites Olathe West. Use the corporate account 100184463 when you book your hotel reservation.

 



Meet the Instructors

Rob Hunter, Ph.D.

Rob Hunter, instructor for Animal Health Regulatory Affairs 101.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

Norm Brown, instructor for Animal Health Regulatory Affairs 101.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.

 


 

Agenda Overviews

Day 1 | Nov. 13

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

• Discovery/Acquisition

  • Preliminary Patent Protection Concerns

•  Submissions

  • Open INAD File
  • NADA (eight sections)
    • CMC
    • TASS
    • Efficacy (field study)
    • Human Food Safety
    • Environmental Impact

• Brief Description of cGxP (GMP, GLP and GCP)

 

Part III: Approval Process: Chemistry, Manufacturing Controls, Environmental Impact and Managing Clinical Trials

CMC

  • API: name, structure, properties
  • Clinical trial material
  • Final formulation

Target Animal Safety

  • Content and format
  • Monitoring and reporting adverse drug events

Human Food Safety

  • Analysis of drug residues
  • Toxicology
  • Residue chemistry
  • Regulatory method

Effectiveness

  • Dosage characterization
  • Substantial evidence (e.g. - dose confirmation and clinical field studies)
  • All other information related to effectiveness

Environmental Impact

Labeling 21 CFR requirements

FOI

• AOI

 

4:30 p.m. | End of Day 1

  

 

 
Day 2 | Nov. 14

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

  • Animal Drug User Fee Act (ADUFA) – Applies to Innovators Only
  • Animal Generic Drug User Fee Act (ADGUF) – Applies to Generic Manufacturers
    • ANADA sections
      • CMC
      • BE (safety and efficacy)
      • HFS
      • All others
    • Types of Fee Waivers and Reductions

 

Part V: Introduction to FDA's Regulation of Veterinary Feed and Veterinary Medical Devices

 Animal Feed

  • GRAS
  • Veterinary Feed Directive (VFD)

 Veterinary Medical Devices CPG 655.100

 

Part VI: Non-Approval-Related Considerations

Extra-Label Drug Use

Compounding

Noncompliance and Enforcement

  • FDA Enforcement Authority over development, manufacturing, marketing and distribution
  • Types of enforcement actions

Pharmacovigilance

 

Part VII: USDA (CVB, APHIS, FSIS) and EPA

USDA's Animal and Plant Health Inspection Service

  • Virus Serum Toxin Act
  • Animal vaccines
  • Animal biologics
  • Animal disease diagnostic devices

EPA

  • Flea and tick products
  • Insect repellants, such as equine fly sprays

• State Registrations

 

4:30 p.m. | End of Day 2/Workshop

  

Additional Opportunities

If you are ready to elevate your career, K-State’s Olathe campus has the educational solutions you need.

Learn how we can help you lead, manage and discover in the growing animal health industry.

Questions/More Information

Angela Buzard

Angela Buzard
Manager, Training and Development
913-307-7340
abuzard@k-state.edu