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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 and for expending product approval
  • The nature of shared jurisdiction over veterinary products in certain cases
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

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.
  • Analyze FDA’s rules governing chemistry, manufacturing and controls or 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.
  • 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
  • Process owners
  • Document control specialists
  • Record retention specialists
  • Legal Professionals
  • Financial Advisors and Institutional Investors
  • Consultants, Inspectors and cGxP Experts
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Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Introduction to the FDA Veterinary Drug Approval Process
  • Introduction to Veterinary Drug Approval process
    • FDA’s jurisdiction and Center’s relevant to Animal Health
      • Center for Food Safety and Applied Nutrition (CFSAN)
      • Center for Drug Evaluation and Research (CDER)
      • Center for Veterinary Medicine (CVM)
    • Specifics of CVM
    • Intro to the FDCA, AMDUCA, ADAA, MUMS, etc and guidance (GFI)
      • Overview of FDCA and regulations
      • Introduction to FDA GFI
  • Overview of Veterinary Drug Develpment
    • Discovery/Acquisition
      • Preliminary Patent Protection Concerns
    • Submissions
      • Open INAD File
      • NADA (8 sections)
        • 5 Major Technical Sections
        • Chemistry, Manufacturing and Controls (CMC)
        • Safety (target animal safety study)
        • Efficacy (field study)
        • Human Food Safety (human food safety studies for food-producing animals)
        • Environmental Impact (EA/CE)
    • 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
    • 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
      • The 7 Major Phases of Animal Field Studies
      • Planning
      • Study Initiation
      • In-life Activities
      • Site close-out
      • Data management
      • Biostatistical analysis
      • Report writing
    • Environmental Impact
      • Categorical Exclusions
      • Environmental Assessments (EA)
      • Common EA Components
      • Environmental Impact Statements (EIS)
    • Labeling 21 CFR requirements
    • FOI
    • AOI
Day 02(8:30 AM - 4:30 PM)
  • 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 & Efficacy)
        • HFS
        • All others
      • Types of User Fees
        • Animal Drug Application and Supplement Fee
        • Animal Drug Product Fee
        • Animal Establishment Fee
        • Animal Drug Sponsor fee
      • Types of Fee Waivers and Reductions
      • Procedures, Timing and FDA Evaluation of Waivers or Reductions
    • FDA decision on approval
  • Introduction to FDA’s Regulation of Veterinary Feed, OTC Drugs and Supplements
    • Animal Feed
      • GRAS
      • 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
  • 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
  • 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
    • Pharmacovigelence
    • Post-approval submissions
      • CMC
      • Safety
      • Efficacy
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Rob Hunter

Rob Hunter
Veterinary Drug Development Specialist

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®, 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.

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September 20-21, 2017, Chicago, IL
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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

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Location:

Chicago, IL
(Venue to be announced shortly)

September 20-21, 2017

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Local Attractions of Chicago, IL

Windy

Windy

One of the more breathtaking scenes on the lake is this tall ship approaching the docks at Navy Pier. The 148-foot four-masted schooner (and its new sister ship, the Windy II ) sets sail for 90-minute cruises two to five times a day, both day and evening. (Because the boats are sometimes booked by groups, the schedule changes each week; call first to confirm sailing times). The boats are at the whims of the wind, so every cruise charts a different course. Passengers are welcome to help raise and trim the sails and occasionally take turns at the ship's helm (with the captain standing close by). The boats are not accessible for people with disabilities.

Adler Planetarium and Astronomy Museum

Adler Planetarium and Astronomy Museum

The building may be historic (it was the first planetarium in the Western Hemisphere), but some of the attractions here will captivate the most jaded video-game addict.
Your first stop should be the modern Sky Pavilion, where the don't-miss experience is the StarRider Theater. Settle down under the massive dome, and you'll take a half-hour interactive virtual-reality trip through the Milky Way and into deep space, featuring a computer-generated 3-D-graphics projection system and controls in the armrest of each seat. Six high-resolution video projectors form a seamless image above your head -- you'll feel as if you're literally floating in space. If you're looking for more entertainment, the Sky Theater shows movies with an astronomical bent; recent shows have included Secrets of Saturn and Mars Now!

Arlington International Racecourse

Arlington International Racecourse

With its gleaming-white, palatial, six-story grandstand and lush gardens, this racecourse is one of the most beautiful showcases for thoroughbred horse racing in the world. Its storied history stretches back to 1927, and such equine stars as Citation, Secretariat, and Cigar have graced the track. The annual Arlington Million (the sport's first million-dollar race, held in mid-Aug) attracts top jockeys, trainers, and horses and is part of the World Series Racing Championship, which includes the Breeders Cup races. Arlington's race days are thrilling to behold, with all of racing's time-honored pageantry on display -- from the bugler in traditional dress to the parade of jockeys.

Art Institute of Chicago

Art Institute of Chicago

You can't -- and shouldn't -- miss the Art Institute. (You really have no excuse, since it's conveniently located right on Michigan Ave. in the heart of downtown.) No matter what medium or century interests you, the Art Institute has something in its collection to fit the bill. Japanese ukiyo-e prints, ancient Egyptian bronzes, Greek vases, 19th-century British photography, masterpieces by most of the greatest names in 20th-century sculpture, and modern American textiles are just some of the works on display, but for a general overview of the museum's collection, take the free "Highlights of the Art Institute" tour Saturday and Sunday.

Auditorium Building and Theatre

Auditorium Building and Theatre

A truly grand theater with historic-landmark status, the Auditorium gives visitors a taste of late-19th-century Chicago opulence. Because it's still a working theater -- not a museum -- it's not always open to the public during the day; to make sure you'll get in, schedule a guided tour, which are offered on Mondays at 10am and noon.
Designed and built in 1889 by Louis Sullivan and Dankmar Adler, the 4,000-seat Auditorium was a wonder of the world: the heaviest (110,000 tons) and most massive modern edifice on earth, the most fireproof building ever constructed, and the tallest building in Chicago. It was also the first large-scale building to be lit by electricity, and its theater was the first in the country to install air-conditioning. Originally the home of the Chicago Opera Company, Sullivan and Adler's masterpiece is defined by powerful arches lit by thousands of bulbs and features Sullivan's trademark ornamentation -- in this case, elaborate golden stenciling and gold plaster medallions. It's equally renowned for otherworldly acoustics and unobstructed sightlines.

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