Veterinary Biologics Training Program

May 13-17, 2024 Ames Iowa

Registration Opens January 2024

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 1996-2023. Over 3450 individuals have attended the program, including 930 international attendees from 97 countries.

Agenda

Day 1
  • Intro to the Center for Veterinary Biologics
  • CVB Website Overview
  • Quality Manufacturing Standards for Veterinary Biologics
  • Intro to CVB Policy, Evaluation, and Licensing
  • Licensing Requirements in the United States
  • 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 Dating
  • Jurisdiction: Permits and Products
  • Risk Management
  • Poultry Specific Licensing
  • Platform and Prescription Platform Biologics
  • US Vaccine Label Regulations
  • Outlines of Production and Labels Workshop

Day 3
  • Immunomudulator Products
  • Aquaculture Biologics
  • Cancer Products
  • Licensing of Veterinary Diagnostic Test Kits
  • FDA-EREA Regulations and CVB
  • IABS Membership Officer
  • Overview of the CVB Laboratory
  • General Question Answer Session

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 and Workshop

Day 5
  • CVB Panel Discussion
  • Record Keeping, Documentation and Process Deviations
  • Quality Assurance, Quality Management
  • Root Cause Analysis Workshop
  • Regulatory Flexibility and Firm Requests
  • Autogenous Biologics
  • Pharmacovigilance

Registration Closed

Registration Options

Participants can register for the entire program or individual days.

Pricing

GroupFull Program: 5 daysSingle Day(s)
Industry$2,300 USD$575
Government / Academic$1,150 USD$290

Upcoming training: May 13-17, 2024 Ames IA

  • Meeting location: Gateway Hotel, Ames IA (see below for lodging links)
  • Recommended Airport: Des Moines International Airport (DSM) is 40 miles (65 km) from the meeting.
  • Meals: Breakfast, lunch, breaks, and 2 dinners (Tue and Thur) are included.
  • International Attendees: We will provide transportation between the DSM Airport and the meeting hotel. You must arrange your own housing at the Gateway Hotel through this link before April 20. If your flight departs before 11 a.m. on Saturday, you must reserve a room Friday night, in Des Moines at a hotel that provides a shuttle to the airport. Note: these will be hotels near the airport (not all Des Moines hotels have shuttles that transport to the airport).
    • Weather averages: Temperature high/low: 70/50 F (21/10 C). Rains more than half of the days in May. Actual high/low temperatures can vary up to 15F/ 8C from the average.
    • Smoking: Not allowed in 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 using Uber or Lyft while in Ames. Food delivery is also an option, we will provide a list of contacts when you arrive.
    • The hotel rooms have telephones that allow free local phone calls (e.g. for food delivery).
  • US Attendees: Conference location: Gateway Hotel, Ames IA . A block of rooms is available until April 20.
  • 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 a 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 veterinary vaccinology.
More information