Advanced Animal Pharmaceutical Workshop
The U.S. Food and Drug Administration's Center for Veterinary Medicine, or FDA CVM, is responsible for the approval of veterinary drug products intended for both family pets and food-producing animals. This workshop on veterinary medicine regulations will provide attendees with a detailed, practical and experienced based review of veterinary drug approval processes. It will be focused on four major technical sections (5 topics) of an FDA CVM product submission: Chemistry, Manufacturing, & Control (CMC); Efficacy; Target Animal Safety; Human Food Safety (HFS); and Bioequivalence (safety and efficacy for generic products).
Participants can attend the training in person or virtually. For those that plan to participate on-campus, all recommended social distancing practices will be in place to aide in participant safety.
This workshop is designed for people tasked with developing and maintaining an animal health company's product portfolio and involved with a company’s regulatory strategies. This includes individuals involved with regulatory affairs, veterinary product development, conducting due diligence for product or company acquisitions, those tasked with ensuring corporate compliance, and members of investment companies working to learn about the industry. Among others, this includes:
- Personnel new to the Industry
- Contract Research Organization (CRO) and Contract Development and Manufacturing Organization (CDMO) employees
- Regulatory agents
- U.S. agents of foreign corporations
- Process owners
- Record retention specialists
- Legal professionals
- Financial advisors and institutional investors
- Consultants, inspectors and cGxP experts
Upon completing this course on veterinary medicine regulations, participants will have learned:
- Details regarding how and what studies, data and information goes into the main technical sections of New Animal Drug Application (NADA – pioneer products) and Abbreviated NADA (ANADA – generic products)
- Practical applications and real-world experience regarding interaction and submission of the major within an FDA/CVM NADA and/or ANADA
- Strategies and plans for navigating the FDA/CVM approval process
$1,500 per person.
The program fee includes:
- Light breakfast, lunch and afternoon refreshments
- Program materials
- Certificate of attendance from an accredited university
A discounted hotel block is available at the Holiday Inn and Suites Olathe West. Use the corporate account 100184463 when you book your hotel reservation.
Rob Hunter, Ph.D.
Dr. 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®, Aviax®, Doxidyl™, A180®, tylosin, Micotil®, Ovugel®, Kexxtone®, ractopamine, Experior™, Posilac® 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. He is the current President of the American Academy of Veterinary Pharmacology and Therapeutics.
Stephanie Batliner has 26 years of animal health pharmaceutical experience with companies including Bimeda Inc., Bayer HealthCare Animal Health Division, Teva Animal Health and Phoenix Scientific Inc. Experienced with all aspects of FDA/CVM Regulatory Affairs, with a focus on chemistry, manufacturing and controls (CMC) and generic animal drugs. She has a deep knowledge of nearly every dosage form and aseptic processing considerations, including Type V Veterinary Master Files. Stephanie has held leadership positions in R&D Technical Development (including analytical methods development, formulation development and technical transfer), Quality Assurance, Quality Control, pre-market Regulatory Affairs and post-market life cycle maintenance Regulatory Affairs. Stephanie has served as Chairperson of Generic Animal Drug Alliance and is currently serving as a working subgroup chair. Stephanie has a Bachelor's of Science in Animal Science from the University of Missouri, Columbia.
Karen Fuller, D.V.M., M.S.
Dr. Karen Fuller is an Independent Consultant for veterinary drug development, specializing in clinical trial protocol development, monitoring, implementation and finalization. During her eight years as a professional in the animal health industry, she focused on clinical and safety research as a Senior Research Scientist for one of the leading animal health companies. Her creativity has helped bring two products to market and played a role in the project development of numerous others. These experiences have helped to shape her drive to advance the veterinary medical field through strengthening the human-animal bond as well as ensuring food security on a global level. Her educational background includes a D.V.M. and M.S. from the University of Illinois- Urbana-Champaign.