Veterinary Biologics Training Program

October 17-21, 2022 Ames Iowa (Virtual option available January, 2023)

Registration is now open!

Updates:

Detailed printable itinerary is now available

The Veterinary Biologics Training Program (VBTP) provides an overview of the USDA regulatory process for assuring the purity, safety, potency and efficacy of veterinary biologics (vaccines, bacterins, antisera, diagnostic kits and other products of biological origin). Representatives from the USDA Animal and Plant Health Inspection Service’s (APHIS) Center for Veterinary Biologics (CVB) present information on the requirements and processes for licensing/registration and testing of veterinary biological products. The inspection and compliance process for production, release and post-marketing surveillance of veterinary biological products is covered in both lectures and workshops.

Professionals working in the veterinary biologics industry, researchers developing biologics, and regulatory personnel are encouraged to attend and learn about current CVB requirements. This course is a highly regarded overview of the current regulatory guidelines in the U.S. The Program is organized by the Institute for International Cooperation in Animal Biologics (IICAB) and is co-sponsored by the USDA APHIS CVB and the Iowa State University College of Veterinary Medicine.

The Program has been offered annually from 1996-2019. Over 3000 individuals have attended the program, including 876 international attendees from 96 countries.

VBTP Photos from 2010 – 2019

Agenda

Day 1

  • Intro to the Center for Veterinary Biologics and Policy, Evaluation, and Licensing
  • CVB Website Overview
  • Quality Standards for Veterinary Biologics
  • Licensing Requirements
  • Outlines of Production
  • Master Seed/Master Cells/Back passage
  • Efficacy Requirements & Interference Studies

Day 2

  • Statistical Considerations for Vaccine Trials
  • Safety Requirements
  • Serial Release Testing
  • Potency Tests
  • Potency Specifications & Product Date
  • Jurisdiction: Products and Permits
  • Risk Management
  • Poultry Specific Licensing
  • Platform and Prescription Platform Biologics
  • US Vaccine Label Regulations
  • Aquaculture Biologics

Day 3

  • Immunomodulators
  • Convention Cancer Products and Autologous Cancer Products
  • Licensing Diagnostic Test Kits
  • FDA-EREA Regulations
  • IABS Membership Officer
  • Center for Veterinary Biologics Lab Overview
  • Label and Outline of Production Workshop
  • New Firms/Products

Day 4

  • CVB Inspection Program
  • Compliance Activities
  • Inspection Categories
  • Inspection Workshop
  • Product Inspection and Serial Release
  • APHIS Form 2008 Workshop
  • Sample Submission and Retention
  • Export Certification
  • Export Workshop

Day 5

  • CVB Panel Discussion
  • Recordkeeping, Documentation and Process Deviations
  • Quality Assurance, Quality Management
  • Root Cause Analysis Workshop
  • Regulatory Flexibility and Firm Requests
  • Autogenous Biologics
  • Pharmacovigilance

Registration Options

Participants can register for the entire program or individual days. We are offering both in-person and virtual options. Registration costs are the same for the virtual or the on-site training. Please register by Sept 1, 2022. Depending on availability, late applications may be accepted.

Pricing

GroupFull Program: 5 daysSingle Day(s)
Industry$2,000 USD$425 USD
Government / Academic$1,000 USD$225 USD

In-Person Attendance: Oct 17-21, 2022 Ames IA

Virtual Attendance:

  • Online access to videos of the In-Person speaker presentations (in English)
  • Opportunity to submit questions via online forum, USDA Center for Veterinary Biologics personnel will respond
  • Access to the presenters’ slides in English
  • Online access starting January 2023 or earlier
  • Access anytime through February 2023
  • View presentations in any order, and at your own pace
  • No CE credit
Veterinary Biologics Training Program

CVB
More information about the USDA Center for Veterinary Biologics

IICAB Immunology Courses
The IICAB offers three courses related to veterinary immunology and vaccinology. The courses range from a five hour introduction to more in depth study of veterinary immunology and vaccinology. This material was part of the VBTP for 15 years and can be helpful for researchers or industry personnel hoping to better understand the veterinary vaccinology.
More information