Agency-related Tracks

FDA-related topics:

• CVM Drug Approval Process
• CMC Overview
• FDA Inspections
• Bioequivalence and Biowaivers
• Industry Perspective of Pharmacovigilance
• EPA/FDA Shared Compliance
• CRO Selection and Oversight
• FOIA Discussion and Differences
• Case Study: Navigating label requirements

USDA-related topics:

• USDA Overview and Licensing
• Reduction on Animal Testing Panel
• Initial Submissions to CVB
• Outlines of Production
• USDA CVB Inspection Process
• Deviations, Root Cause Analysis, CAPAs
• USDA Pharmacovigilance
• Case Study: Writing an outline for production
  

Shared topics:

• Ensuring Efficacy: Essential Strategies for Designing Veterinary Clinical Trials
• VICH and International Regulations Overview Panel
• An Introduction to Veterinary Biological, Pharmaceutical and Pesticide Regulatory Affairs
  

Daily Line-up

Day 1

• An Introduction to Veterinary Biological, Pharmaceutical and Pesticide Regulatory Affairs
• CVM Drug Approval Process
• CMC Overview
• USDA Overview and Licensing
• Bioequivalence and Biowaivers
• Reduction on Animal Testing Panel
• Initial Submissions to CVB

Day 2

• Ensuring Efficacy: Essential Strategies for Designing Veterinary Clinical Trials
• Industry Perspective of Pharmacovigilance
• USDA Outlines of Production
• Building and Understanding Emotional Intelligence: Generations and Timeless Leadership

Day 3

• EPA/FDA Shared Compliance
• CRO Selection and Oversight
• USDA CVB Inspection Process
• FOIA Discussion and Differences
• FDA Inspections
• Deviations, Root Cause Analysis, CAPAs
• USDA Pharmacovigilance
• VICH and International Regulations Overview Panel
• Case Study: Writing an outline for production
• Case Study: Navigating label requirements