Advanced Animal Biologics Workshop
The U.S. Department of Agriculture's Center for Veterinary Biologics (USDA CVB) regulates veterinary biologics available for the diagnosis, prevention and treatment of both companion and food producing animals. This workshop will cover practical issues in animal health regulatory affairs as it relates to the development of vaccines and other biologics to aid in assuring developed biologics are pure, safe, potent and effective.
The workshop will provide a history of applicable regulations and an understanding of the integration of science into successful product approvals. Instruction will include: How to achieve target label claims for developing new products, while ensuring the product is pure, safe and effective; the planning, design and requirements for conducting pre-clinical and clinical trials; protocol design and the evaluation and assessment of the regulatory submission; as well as the requirements following licensure of the product will also be presented. The course will be delivered in an interactive format to encourage group learning and will be based on experience and practical industry examples.
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 pharmaceutical regulations participants will have learned:
- Terminology, definitions and the history of veterinary biologic laws and regulations
- How it is determined whether USDA or FDA has jurisdiction over the products
- How submissions are made to the agency
- Overview of the registration and licensing process
- Overview of the types of products licensed by the CVB (Autogenous, Antibody, Platform, Prescription, Diagnostic Test Kits, etc.)
- Master seed and cell concepts
- Risk assessment documents
- Immunogenicity study requirements
- Assay development and validation
- Other required studies for licensure (Reversion to virulence, safety, efficacy, etc)
- Labeling and packaging requirements
- Requirements for an Outline of Production
- Requirements for USDA production, quality facilities, and quality systems
- Compliance following licensure
- Review of the items that the agency will review during an audit
- Facility documents, 2007 forms and 2008 forms
- Review of appropriate Advertising and Promotional Materials
$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.
Norm Brown has 35 years of veterinary vaccine regulatory and quality experience with companies including Boehringer-Ingelheim Animal Health, Merck Animal Health, Diamond Animal Health and Mallinckrodt Veterinary. Mr. Brown is an experienced leader with a diverse background and a customer-oriented approach. His background specifically includes regulatory and compliance resolution, new product registration, product complaint resolution, international registration, system critique, and continuous improvement implementation. Mr. Brown graduated from University of Nebraska with an B.S. in Microbiology and an M.S. in Veterinary Services.
Terrie Jo Hamtak
Terrie Jo Hamtak started her career in human health as a microbiologist from California State University- Long Beach, before entering the animal health world at the Veterinary Medical Diagnostic, University of Missouri, Columbia. From the veterinary diagnostic arena, she moved into the animal health industry working for several large firms in various departments from Quality, Virus Production, Regulatory Affairs, R&D, Quality Technical Support and most recently Compliance Programs. Mrs. Hamtak is currently the director of Large Molecules Compliance Programs for Intervet Inc. d/b/a Merck Animal Health with a major focus on regulatory and quality management compliance. She also actively pursues activities in animal health organizations, including but not limited to, the Animal Health Institute (AHI) and the Association of Veterinary Biologics Companies (AVBC). One never stops learning, even after 40 years in the industry. She notes that she learn something new and exciting about the world of animal health and compliance every day. On a personal note, Terrie Jo keeps very busy with training her puppy training as a service dog for her husband, as well as being a gardener with a love of roses.
Helen Smith received her Bachelor of Science and Master of Science degrees from the University of Guelph. Following graduation in 1992, she joined Langford Laboratories, then a division of Cyanamid Canada, supervising the Viral Quality Control group and developing a Viral Research and Development team. Following a company takeover and then a subsequent move to Fort Dodge, Helen continued work in Bovine Viral R&D. After a brief interlude in Assay Development, Helen started her career in Biological Regulatory Affairs in 1998 with Fort Dodge Animal Health. Through changes in companies and mergers Helen continued her career in Biological Regulatory Affairs at Schering-Plough Animal Health, which became part of Merck Animal Health. She joined Boehringer Ingelheim in 2016 and is currently the Head of U.S. Biological Regulatory Affairs for Livestock and Equine.