The Veterinary Drug Approval Process and FDA Regulatory Oversight: 2-day In-Person Seminar

By: Mark Hughes, Consultant, Hughes Veterinary Consulting
Location :- Sheraton Suites Country Club Plaza Kansas City, MO | Thursday, September 26, 2019 | Friday, September 27, 2019

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Course Description:

The U.S. Food and Drug Administration’s Center for Veterinary Medicine or 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 a number of 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.

This seminar on veterinary medicine regulations will provide attendees with an understanding of FDA’s veterinary drug approval process. This two day interactive course will cover:

  • Premarket approval process
  • Various sections of a New Animal Drug Application
  • Strategies for navigating the FDA approval process

Learning Objectives:

Upon completing this course on veterinary medicine regulations participants will:

  • Understand how the U.S. Food and Drug Administration regulates veterinary drug product.
  • Understand how FDA’s Center for Veterinary Medicine is organized.
  • Discuss the process by which veterinary drug products are reviewed and approved.
  • Learn how to open an INAD File and request fee waivers.
  • Obtain a working knowledge of various sections included within an NADA.
  • Develop a deep understanding of what is needed to substantiate product characterization, target safety and effectiveness.
  • Gain general understanding of FDA’s rules governing chemistry, manufacturing and controls (CMC).
  • Understand the various components of an animal field study to support product approval.
  • Discuss the difference between FDA’s various user fees and fee waivers.
  • Identify the elements of an FDA compliant label.
  • Develop a corporate compliance strategy covering labeling, marketing and advertising.
  • Explore problem solving methods to mitigate regulatory enforcement risks.
  • Explain how jurisdiction is split between various Federal agencies in a certain cases.
  • Learn how animal feed, veterinary devices, OTC drug products and nutritional supplement are regulated in the U.S.


Who will Benefit:

This course is designed for people tasked with developing and maintaining an animal health company’s product portfolio and responsible for overseeing a company’s regulatory strategies. This includes individuals responsible for overseeing regulatory affairs, developing veterinary drug products, evaluating new technologies or applications, and those tasked with ensuring corporate compliance. 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
  • Document control specialists
  • Record retention specialists
  • Legal Professionals
  • Financial Advisors and Institutional Investors
  • Consultants, Inspectors and cGxP Experts

Course Outline

Day One (8:30 AM – 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Introduction to Veterinary Drug Approval process
    • FDA’s jurisdiction and Centers relevant to Animal Health
      • Center for Food Safety and Applied Nutrition (CFSAN)
      • Center for Drug Evaluation and Research (CDER)
      • Center for Biologics Evaluation and Research (CBER)
      • Center for Veterinary Medicine (CVM)
    • Specifics of CVM
    • Intro to the FD&CA, AMDUCA, ADAA, FDAMA, MUMS, and guidance documents(GFI)
      • Overview of FDCA and regulations
      • Drugs versus Biologics
      •  Introduction to FDA Guidance for Industry (GFI) and other online resources
  • Overview of Veterinary Drug Development (NADA Pioneer Drugs)
    • Discovery/Acquisition
      • Preliminary Patent Protection Concerns
    • Submissions
      • Open INAD File
        • Sponsor information
        • Responsible Official
        • Product description
        • Target species and proposed indication
      • Early Information
      • Phased review
      • NADA (8 sections)
        • 5 Major Technical Sections
          • Chemistry, Manufacturing and Controls (CMC)
          • Safety (target animal safety study)
          • Effectiveness (clinical field study)
          • Human Food Safety (human food safety studies for food-producing animals)
          • Environmental Impact (EA/CE)
      • 3 Minor Technical Sections
        • Label
        • Freedom of Information summary (FOI)
        • All Other Information (AOI)
      • Administrative NADA
    • Brief Description of cGxP (GMP, GLP, & GCP)
  • Approval Process: Chemistry, Manufacturing Controls, Environmental Impact & Managing Clinical Trials
    • CMC
      • API: name, structure, properties
      • API manufacturing
      • Clinical Trial material
      • Final Formulation
      • VMF/DMF
    • Target Animal Safety
      • Content and format
      • Final Study Reports
      • Monitoring and Reporting Adverse Drug Events
    • Human Food Safety
      • Analysis of Drug Residues
      • Toxicology
      • Residue Chemistry
      • Microbial Food Safety
      • Regulatory Method Relied Upon by Sponsor
    • Effectiveness
      • Dosage Characterization
      • Substantial evidence (e.g. dose confirmation and clinical field studies)
      • All other information related to effectiveness
      • Proposed effectiveness-related labeling
      • Effectiveness Guidance Documents
      • Laboratory studies can be used to provide effectiveness data
      • The 7 Major Phases of Animal Field Studies
        • Planning
        • Study Initiation
        • In-life Activities
        • Site close-out
        • Data management
        • Biostatistical analysis
        • Report writing and preparing raw data files
      • Data collection and study documentation
    • Environmental Impact
      • Categorical Exclusions
      • Environmental Assessments (EA)
      • Common EA Components
      • Environmental Impact Statements (EIS)
    • Labeling 21 CFR requirements
    • FOI
    • AOI
  • Day Two (8:30 AM – 4:30 PM)
    1. Overview of Generic Animal Drugs (JINAD)
      • Submissions
        • ANADA sections
          • CMC
          • Bioequivalence (Safety & Efficacy)
          • Human Food Safety
          • All others
    2. Minor Use Minor Species (MUMS)
      • Designation
      • Indexing
    3. 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 (AGDUFA) – Applies to Generic Manufacturers
      • Types of User Fees
        • Animal Drug Application and Supplement Fee
        • Animal Drug Product Fee
        • Animal Drug Establishment Fee
        • Animal Drug Sponsor Fee
      • Types of Fee Waivers and Reductions
      • Procedures, Timing and FDA Evaluation of Waivers or Reductions
    4. Introduction to FDA’s Regulation of Veterinary Feed, OTC Drugs, Supplements and Medical Devices
      • Animal Feed
        • GRAS – 21 CFR 582
        • Feed Labeling
        • AAFCO
        • Veterinary Feed Directive (VFD)
      • Veterinary OTC Drugs and Nutritional Supplements
        • Regulatory Agencies
        • CVM Compliance Policy - CPG 690.150 & CPG 690.100
      • Veterinary Medical Devices CPG 655.100
    5. USDA (CVB, APHIS, FSIS) & EPA
      • USDA’s Animal and Plant Health Inspection Service
        • Virus Serum Toxin Act
          • Animal vaccines
          • Animal biologics
          • Animal disease diagnostic devices
      • EPA
        • Flea & Tick Products
        • Insect Repellants such as Equine Fly Sprays
        • State Registrations
    6. Non-Approval-Related Considerations
      • Extra-Label Drug Use
      • Compounding
      • Noncompliance and Enforcement
        • FDA Enforcement Authority over Development, Manufacture, Marketing, and Distribution
          • FDA’s Office of Regulatory Affairs (ORA): Responsible for field activities, imports, inspections, and enforcement policy
          • Local, State, and Tribal governments
          • CVM’s Office of Surveillance and Compliance
        • Types of Enforcement Actions
      • Pharmacovigilance
      • Post-approval submissions
        • CMC
        • Safety
        • Efficacy

    Meet Your Instructors

    Mark Hughes
    Mark Hughes,
    Consultant, Hughes Veterinary Consulting

    Dr. Mark Hughes, DVM, MS, has over 11 years of experience in veterinary drug product development and over 20 years of experience in laboratory animal medicine, development of in-vitro diagnostic tests, and research in animal reproduction. He has managed or contributed to clinical studies and regulatory submissions on the safety and effectiveness of veterinary drugs (including stem cells) for therapeutic treatments related to dermatology, cardiology, endocrinology, oncology, osteoarthritis, and infectious diseases. Through his consulting business, Hughes Veterinary Consulting, he assists domestic and international biotech and pharmaceutical companies with the process of applying for regulatory approval of drug products for use in companion animals and livestock.

    Venue

    Location :

    Sheraton Suites Country Club Plaza
    770 W 47th Street
    Kansas City, MO 64112, USA
    Tel: +1-816-931-4400

    September 26-27, 2019



    How to Reach

    General Driving Directions:

    Driving directions from Kansas City International Airport
    • Get on I-29 S/US-71 S in May from International Cir, Cookingham Dr and NW 120th St,
    • Continue on I-29 S to Gallatin Township.
    • Take the MO-9 S exit from US-169 S, Get on I-35 S/I-70 W/US-24 W in Kaw Township.
    • Continue on I-35 S to Summit St/SW Trafficway.
    • Take exit 1A from I-35 S, Continue on SW Trafficway. Drive to Summit St

    Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. GRC Seminars is not responsible for any inaccuracies in the same.
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    Seminar One Registration

    September 26-27, 2019, Kansas City, MO

    The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both the days.

    The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both the days.
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    Local Attractions of Kansas City, MO

    Country Club Plaza
    With amazing shops, great restaurants and those famed Kansas City fountains, the world famous Country Club Plaza gets the top pick of About Kansas City's attractions and destinations. The Plaza (as locals call it) was the US's first outdoor shopping, dining and entertainment district and is wonderful any time of year.

    Nelson - Atkins Museum of Art
    The world renowned Nelson-Atkins Museum of Art (4525 Oak) is one of Kansas City's most treasured gems. With amazing exhibits both inside and out--the Nelson-Atkins boasts one of the most impressive collections anywhere. With everything from ancient Egyptian sculptures and Japanese collection with more than 2,000 works of art ranging from the 10th century B.C.E. you could spend days looking at everything.

    Worlds of Fun
    Worlds of Fun is the premier amusement park destination in the Midwest, offering 235 acres of excitement and fun for every member of the family, including the newly renovated Oceans of Fun. Come to Worlds of Fun to ride on & slide on all day long.


    Kansas City Zoo
    The Kansas City Zoo and its adjoining IMAX Theater is a great attraction for those young and old alike. The Zoo has gone through a major transformation in the last few years and boasts over 200 acres with over 900 animals.

    Union Station/ Science City
    The fully restored Union Station is one of Kansas City's favorite attractions with plenty of great things to see and do. With everything from the fully interactive Science City and its famed Rail Exhibit to movies, planetarium shows and world famous exhibits (think Dead Sea Scrolls and Titanic). They've also got some great restaurants like the famed Pierpont's and the Union Cafe if all that attraction going makes you hungry.