Schedule

Our team is working to finalize sessions, breakout panels, networking opportunities and more that are informative and beneficial. More detailed information about the topics listed below will be posted soon.

Day 1

• Who Regulates What Products? A Discussion on Agency History and Jurisdictions
• FDA Overview
• CMC Overview
• USDA Overview
• Bioequivalence and Biowaivers
• Reduction on Animal Testing Panel
• Initial Submissions to CVB
• Dinner with the subject matter expert of your choice at a nearby restaurant.

Day 2

• Clinical Efficacy and Study Design
• Industry Perspective of Pharmacovigilance
• Outlines of Production
• Professional Skills Workshop: Understanding Emotional Intelligence and Navigating a Multigenerational Workplace

Day 3

• EPA/FDA Shared Compliance
• CRO Selection and Compliance
• USDA Inspections
• USDA and FDA FOIA Discussion and Differences
• FDA Inspections
• Deviations, Root Cause Analysis, CAPAs
• CVB Pharmacovigilance Process
• VICH and International Regulations Overview Panel
• Case Study: Writing an Outline for Production
• Case Study: Navigating Label Requirements