Uninterrupted availability of Veterinary Active Pharmaceutical Ingredients (APIs) to the pharmaceutical industry is critical. As regulatory standards and Pharmacopeial standards evolve, issues may arise resulting in Import Alerts, supply chain interruptions and drug shortages. This workshop is designed to help understand the issues that arise between Industry and regulatory bodies pertaining to Active Pharmaceutical Ingredients and Veterinary Master Files to better facilitate processes and provide solutions. The workshop will bring Industry and regulators together in an interactive environment with presentations and panel discussions covering all aspects of Veterinary Active Pharmaceutical Ingredients.
Participating groups include:
- United States Pharmacopeia (USP)
- Generic Animal Drug Alliance (GADA)
- Federal Regulatory Agencies
- Animal Health Institute (AHI)
- Veterinary Industry Sponsors
- Active Pharmaceutical Ingredient Manufacturers, Suppliers and US Agents
Attending this workshop will help all participants understand what it takes to make Active Pharmaceutical Ingredients (APIs) available to U.S. Drug Product sponsors. This workshop aims to provide insight to better facilitate processes relating to APIs and Veterinary Master Files. The intent is to create an interactive environment for discussion of valuable regulatory information, enabling attendees to understand the big picture process of API manufacturing site approval, API manufacturing requirements, progression of current USP testing requirements and revisions, Sponsor API source approval, and current regulatory issues.
Who Should Participate?
Veterinary API Manufacturers, Suppliers and US Agents
Veterinary Finished Dosage Form Manufacturers’ Representatives
Veterinary Drug Product Sponsors
QA / QC Representatives
Regulatory Affairs Professionals
Federal Regulatory Reviewers
Regulatory Consumer Safety Officers
Key Workshop Topics
Challenges to Keeping APIs on the Market
- API and Drug Shortages
- Availability of Starting Materials
- Import Alerts
- cGMP compliance and data integrity
- Medically Necessary API’s and Drug Products
USP Pharmacopeial Forum Industry Education
- Keeping up with revisions and current USP requirements
USP Reference Standards and Monograph Development Processes
Veterinary Master Files – Type II
- Components and Maintenance of Type II Veterinary Master Files
- Practical eSubmitter issues with Veterinary Master File submissions
- Top Type II Veterinary Master File Deficiencies Observed During Review
Workshop Planning Committee
Frank Amorese, Flavine North America
Melanie Archer, Cronus Pharma
Rachel Cumberbatch, AHI
Kathy DeMarco, GADA
Marco D'urso, Chemwerth
Herschel Gaddy, HJG Associates
Annette Johnson, Norbrook Inc.
Jan Karibian, Virbac Corp. (US)
Michael Kerrigan, CVM
Gerald Macedo, Med-Pharmex
Shrikant Makode, Alivira Animal Health Limited (A Sequent Company)
Morgan Puderbaugh, USP
Courtney Tallman, Med-Pharmex
Vivek Varade, Alivira Animal Health Limited (A Sequent Company)
Brian Wachter, Boehringer Ingelheim
Workshop Registration Information
Advance registration will be available through Monday, July 16, 2018. After that date, registration will be available on site at the USP Meetings Center.
Registration is payable by credit card only. Registration fee includes the full two-day program, meeting materials, coffee breaks and lunches. Registration fees for this workshop have been set as follows:
|Participant Type||Regular Fee Per Person
(1-2 individuals from the same organization)
(3 or more individuals from the same organization; all must register at the same time to receive the discount)
Cancellation and Substitution Policy
Cancellation must be received on or before June 27, 2018 (21 days prior to the event) via email to firstname.lastname@example.org. Refunds will not be issued for cancellations received after this date. There is a $50.00 processing fee on all cancellations; however, it is permissible to send a substitute registrant from your same organization. Substitutions must be submitted in writing via email to email@example.com.
Invitation Letters for Visas
USP cannot provide an invitation letter to potential workshop attendees; however, once you are registered, USP will provide a registration confirmation that may be utilized to obtain a visa.
Please contact firstname.lastname@example.org or +1 301-816-8130.
Travel and Hotel Information
Please note that the headquarter hotel for this workshop is the Cambria Rockville. Daily Shuttle service will be provided between USP and the Cambria only. Please note that room availability at the Cambria is extremely limited at this time.
For information on additional local hotels, please click here.