The Veterinary Drug Approval Process and FDA Regulatory Oversight: 2-day In-Person Seminar
Rob Hunter, Veterinary Drug Development Specialist
Kansas City, MO
| Thursday, December 15, 2016 | Friday, December 16, 2016
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
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.
Seminar Fee Includes:
USB with seminar presentation
Hard copy of presentation
$100 Gift Cert for next seminar
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
|Day 1 (8:30 AM – 4:30 PM)
||Day 2 (8:30 AM – 4:30 PM)
- 8:30 – 9:00 AM: Registration
- 9:00 AM: Session Start Time
- Introduction to Veterinary Drug Approval process
Overview of Veterinary Drug Development
- 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
- Preliminary Patent Protection Concerns
- 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)
- 3 Minor Technical Sections
- All other information
- Freedom of Information Summary (FOI)
- Brief Description of cGxP (GMP, GLP, &GCP)
- 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
- Residue Chemistry
- Microbial Food Safety
- Regulatory Method Relied Upon by Sponsor
- Dosage Characterization
- Substantial evidence (e.g. dose confirmation and clinical field studies)
- All other information related to effectiveness
- Proposed effectiveness-related labelling
- Effectiveness Guidance Documents
- The 7 Major Phases of Animal Field Studies
- Study Initiation
- In-life Activities
- Site close-out
- Data management
- Biostatistical analysis
- Report Writing
- Approval Process: Chemistry, Manufacturing Controls, Environmental Impact & Managing Clinical Trials
Animal Drug User Fees and Related Fee Waivers
- Environmental Impact
- Categorical Exclusions
- Environmental Assessments (EA)
- Common EA Components
- Environmental Impact Statements (EIS)
Introduction to FDA’s Regulation of Veterinary Feed, OTC Drugs and Supplements
- 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
- BE (Safety & Efficacy)
- 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
USDA (CVB, APHIS, FSIS) & EPA
- Animal Feed
- Feed Labeling
- 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’s Animal and Plant Health Inspection Service
- Virus Serum Toxin Act
- Animal vaccines
- Animal biologics
- Animal disease diagnostic devices
- Flea & Tick Products
- Insect Repellants such as Equine Fly Sprays
- State Registrations
- Extra-Label Drug Use
- 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
Importance of Patent Protection: Right to Enforce
Meet Your Instructor
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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Kansas City, MO(Venue to be announced shortly)
December 15-16, 2016
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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.
Liberty Memorial and the National WW1 Museum
Liberty Memorial and the WWI museum is the United States official WWI Museum and honor those who served in WWI and honor the memory of the sacrifices those who served made. This interactive exhibit shows the consequences WWI had and the impact it had on the US as a country. The museum and memorial serve as the leading educational institute and resource of WWI. Head to the top of the Liberty Memorial for some of the best 360 view of Kansas City.
Located just east of Kansas City Powell Gardens is an amazing 900+ acre botanical garden that boasts amazing displays of plants and flowers that are in bloom any time of year. The displays change with the seasons, so you'll never see the same thing twice at Powell Gardens and is beautiful year-round.