Two Day Veterinary Drug Approval Process and FDA Regulatory Oversight Course (Kansas City, Missouri, United States - June 13-14, 2017) - Research and Markets
DUBLIN, April 24, 2017 /PRNewswire/ --
Research and Markets has announced the addition of the "The Veterinary Drug Approval Process and FDA Regulatory Oversight: 2-day In-Person Seminar" conference to their offering.
This seminar on veterinary medicine regulations will provide attendees with a comprehensive understanding of FDA's veterinary drug approval process.
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. FDA regulates not 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 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.
Learning Objectives:
- 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.
Agenda:
Day 1 (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 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 Development
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)
- 3 Minor Technical Sections
- All other information
- Labeling
- Freedom of Information Summary (FOI)
Brief Description of cGxP (GMP, GLP, &GCP)
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 labelling
- 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
Day 2 (8:30 AM - 4:30 PM)
Approval Process: Chemistry, Manufacturing Controls, Environmental Impact & Managing Clinical Trials
- Environmental Impact
- Categorical Exclusions
- Environmental Assessments (EA)
- Common EA Components
- Environmental Impact Statements (EIS)
- Labeling
- FOI
- AOI
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
Importance of Patent Protection: Right to Enforce
For more information about this conference visit http://www.researchandmarkets.com/research/h6p6wc/the_veterinary
Media Contact:
Laura Wood, Senior Manager
press@researchandmarkets.com
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