Veterinary Biologics Training Program

May 15-19, 2023 Ames Iowa

Registration is now closed.

Registration will open in February 2023

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 1996-2022. Over 3000 individuals have attended the program, including 876 international attendees from 96 countries.

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

Registration for the May 2023 training will open in February 2023. Participants can register for the entire program or individual days.

Pricing

GroupFull Program: 5 daysSingle Day(s)
Industry$2,200 USD$550
Government / Academic$1,100 USD$275

Upcoming training: May 15-19, 2023 Ames IA

  • Meals: Breakfast, lunch, breaks, and 2 dinners (Mon and Thur) are included.
  • Meeting location: Gateway Hotel, Ames IA
  • Recommended Airport: Des Moines International Airport (DSM) is 40 miles (65 km) from the meeting.
  • International Attendees: We will provide transportation between the DSM Airport and the meeting hotel. You must arrange your own housing at the Gateway Hotel. If your flight departs on Saturday please plan to stay in Des Moines at a hotel with an airport shuttle Friday night.
    • Weather: Temperature average high/low: 70/50 F (21/10 C). Rains some more than half of the days. Highs and lows can vary up to 15F/ 8C.
    • Smoking: Not allowed most places (hotel rooms, meeting rooms, meeting building) Only allowed in limited outdoor locations.
    • Shopping/Dining/Transporation: Ames is a typical Iowa town that is very spread out. Restaurants and shopping are 3-8 mi (5-13km) from the meeting hotel. There is a public bus system , but it has limited routes. You may want to plan on renting a car at the Des Moines airport or use Uber or Lyft while in Ames.
  • US Attendees: You may contact the Gateway Hotel, Ames IA> to inquire about housing availability.
  • Useful information about Ames
  • RACE® CE: The program was approved by the Registry of Approved Continuing Education  for in-person attendance by veterinarians or veterinary technicians for 35 hours of CE.
  • Presentations will be in English, we will provide access to the presenters’ slides.
  • Covid-19 policies will be consistent with CDC, State of Iowa, Iowa State University, and City of Ames applicable recommendations.
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