The Development of veterinary biologics, involves a complex series of clinical studies and analytical programs to assure the quality and effectiveness of these products. Biologicals are commonly vaccines and include conventional viral based products, bacterins, toxins, rDNA products and antibody products.
The basic development programs for theses vaccines are similar, but differences will be highlighted. It should be recognized that unlike human vaccines the Center for Veterinary Biologics registers hundreds of types of vaccines, but all are developed and registered using the Master Seed concept to assure vaccines made years from now, and those developed years ago are made according to the same standards and the consumers can expect the same quality.
The frame of Studies used to develop label indications will described as well as the testing programs on the products to assure quality over there shelf life Considerations and requirements for importing biological materials and the implications of failure to follow those requirements as well as the potential consequences will be described.
Why should you Attend:
Veterinary Biologicals - largely vaccines but also antibody products and certain test kits are commonly used in both our Companion Animals (cats, dogs, horses) and Livestock (cattle, swine, poultry and fish) to prevent and occasionally treat disease. Some of the diseases prevented by these products are for zoonotic diseases such as Rabies and Leptospirosis which can have serious if not fatal outcomes in humans.
This presentation provides the background information on the development programs undertaken by the manufactures of these products and the regulatory requirements set for by the United State Departments of Agricultures Center for Veterinary Biologics.
Attending this session not only provides this background information, but also the extensive effort undertaken to assure these products are safe pure potent and effective. They help assure the health of our pets, and the safety of our food supply
Areas Covered in the Session:
Over of the regulatory framework for veterinary biological and how if differs from pharmaceutical products, and the United State Departments of Agricultures Center for Veterinary Biologics
Master Seed concept
Clinical program for Efficacy
Clinical program for Safety
Import and export considerations
Who Will Benefit:
Start up ventures including vaccine companies
Students considering careers in veterinary Biologicals
Hans Draayer has over 30 years of experience in the biological industry working for major corporations including Pfizer, SmithKline Beecham and Beecham Laboratories. During this time he has held various senior Regulatory and R&D management roles and has developed and licensed vaccines for all major species with the USDA Center for Veterinary Biologics.
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