Veterinary Biologics Training Program

2021 Program – Virtual Only (Registration is now closed)

The Veterinary Biologics Training Program was offered online due to the COVID resurgence and related local policies.

  • Online access will be available starting October 1, 2021 (or sooner)
  • Access video lectures and downloadable presenter’s slides through Nov 30, 2021
  • Ask questions through an online forum. USDA Center for Veterinary Biologics personnel will respond.
  • Live Q&A October 29,2021 from 9:00-11:00 AM Central Daylight Time (UTC – GMT -5h)

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
  • Quality Standards for Veterinary Biologics
  • Licensing Requirements
  • CVB Website Overview
  • Outlines of Production
  • Master Seed/Master Cells/ Back passage
  • Efficacy Requirements

Day 2

  • Statistical Considerations
  • Safety Requirements
  • Serial Release Testing
  • Center for Veterinary Biologics Lab Overview
  • Test Validation
  • Label Requirements
  • Regulating Biotech Products, Summary Information Format
  • Risk Analysis
  • Platform and Prescription Platform Biologics
  • Aquaculture Biologics
  • Poultry Specific Licensing

Day 3

  • Immunomodulators
  • Autologous/Cancer
  • Importation of Products
  • FDA-EREA Regulations
  • Licensing Diagnostic Test Kits
  • New Product Review

Day 4

  • CVB Inspection Program
  • Compliance Activities
  • Inspection Categories
  • Inspection Workshop
  • Product Inspection and Release
  • APHIS Form 2008 Workshop
  • Export Certification
  • Export Workshop
  • Pharmacovigilance

Day 5

  • CVB Panel Discussion
  • Quality Assurance, Quality Management
  • Recordkeeping
  • Root Cause Analysis Workshop
  • Regulatory Flexibility and Firm Requests
  • Autogenous Biologics
  • Sample Evaluation Workshop

Registration Options

Participants can register for the entire program or individual days.

Pricing

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

Virtual Attendance:

  • Online access to videos of the In-Person speaker presentations (in English)
  • Opportunity to submit questions via online forum
  • Access to the presenters’ slides in English
  • Online access starting October 1, 2021 or sooner
  • Access anytime through November 2021
  • Live online Q&A with CVB personnel October 29, 2021 9:00-11:00 AM Central Daylight Time (UTC/GMT -5h).
  • View presentations in any order, and at your own pace
  • No CE credit

2022 Training Program

Scheduled as an in-person meeting in Ames IA for May 16-20, 2022. (Subject to applicable disease control policies at the time.)

Veterinary Biologics Training Program

Registration is now closed

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