home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
  HUM-MOLGEN -> Events -> Meetings and Conferences
Search  -  prev / next
 
 

The Veterinary Drug Approval Process and FDA Regulatory Oversight

 
  February 03, 2021  
     
 
ComplianceOnline, online event
24 February 2021


DAY 01(9:00 AM TO 1:00 PM PST)
  • Introduction to the Veterinary Drug Approval Process
    • Definitions
    • INAD/NADA technical sections
    • Some differences between human and animal drug approval process
    • FDA organization and jurisdiction
      • FDA Centers relevant to Animal Health
    • Introduction to Federal Regulations (FD&CA, AMDUCA, ADAA, FDAMA)
    • FDA Guidance documents and other online resources
    • Discovery/Acquisition - Preliminary Patent Protection Concerns
    • INAD/NADA Phased Review
      • Open an INAD File
      • Submit Early Information
      • Phased Review of Technical Sections
    • Meetings with CVM
    • Brief description of cGxP (GMP, GLP, GCP)
DAY 02(9:00 AM TO 1:00 PM PST)
  • Developing the NADA Technical Sections
    • Chemistry, Manufacturing, Controls (CMC)
    • Effectiveness
      • The 7 Major Phases of Clinical Field Studies
    • Target Animal Safety (TAS)
    • Human Food Safety
    • Environmental Impact
    • Labeling
    • Freedom of Information (FOI) Summary
    • All Other Information (AOI)
  • Overview of Generic Animal Drugs (JINAD)
    • Submissions - ANADA sections
      • CMC
      • Bioequivalence (Safety & Efficacy)
      • Human Food Safety
      • Labeling
DAY 03(9:00 AM TO 1:00 PM PST)
  • Minor Use Minor Species (MUMS)
    • Designation
    • Indexing
  • Marketing Exclusivity & Exclusive Marketing Rights
  • Animal Drug User Fees and related waivers
  • Animal Feed, OTC Drugs, Supplements, Medical Devices
  • Animal health products regulated by USDA & EPA
  • Non-Approval-Related Considerations
    • Extra-Label Drug Use
    • Compounding
    • Noncompliance and Enforcement
    • Pharmacovigilance
    • Post-approval submissions for CMC changes
  • Review of the Typical Steps in Veterinary Drug Development
  1. Because procurement is handled differently in every company, we examine basic considerations only.
 
 
Organized by: ComplianceOnline
Invited Speakers:

Dr. Mark Hughes, DVM, MS, has over 11 years of experience in veterinary drug product development and over 20 years of experience in laboratory animal medicine, development of in-vitro diagnostic tests, and research in animal reproduction. He has managed or contributed to clinical studies and regulatory submissions on the safety and effectiveness of veterinary drugs (including stem cells) for therapeutic treatments related to dermatology, cardiology, endocrinology, oncology, osteoarthritis, and infectious diseases. Through his consulting business, Hughes Veterinary Consulting, he assists domestic and international biotech and pharmaceutical companies with the process of applying for regulatory approval of drug products for use in companion animals and livestock.

 
Deadline for Abstracts: 22.2.2021
 
Registration: Register by phone or need assistance? Call +1-888-717-2436

E-mail: referral@complianceonline.com
 
 
   
 
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
 
 

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995-2021 HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.