05. mars 2020 - 8:30
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The Veterinary Drug Approval Process and FDA Regulatory Oversight: 2-Day In-Person Seminar | Orlando | jeudi, 05. mars 2020

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. 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 seminar on veterinary medicine regulations will provide attendees with a comprehensive 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.

 
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 strategies for obtaining veterinary drug product approvals and those tasked with ensuring corporate compliance. Among others, this includes:

Senior quality managers
Quality professionals
Regulatory professionals
Compliance professionals
Production supervisors
Manufacturing engineers
Production engineers
Design engineers
Labelers and Private Labelers
Contract Manufacturers
Importers and Custom Agents
U.S. Agents of Foreign Corporations
Process owners
Quality engineers
Quality auditors
Document control specialists
Record retention specialists
Medical affairs
Legal Professionals
Financial Advisors and Institutional Investors
Consultants, Inspectors and cGMP Experts

 
Speaker:








Mark HughesConsultant, 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.











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Note: Use coupon code REFERRAL10 and get 10% off on registration.