Day 1 Agenda
8:30 a.m. | Welcome and Introductions
Lauren Racki, Manager of Professional Development, K-State Olathe
Rob Hunter, Ph.D., Lead Advisor and Instructor, K-State Olathe
Beth Kee, D.V.M., Senior Director of Clinical Development and Study Operations, Animal Clinical Investigation (ACI)
Stephanie Batliner, Director of R&D and Regulatory Affairs North America, Bimeda
8:45 a.m. | Introduction to CMC (Stephanie Batliner)
- Guidance documents
- Pharmacopeia
- Supply Chain considerations throughout
Drug Substance (Stephanie Batliner)
- Characterization
- Manufacturer
- Specifications
- Analytical Methods
- Drug master files, Type II VMF
10 a.m. | Break
10:15 a.m. | Drug Product (Stephanie Batliner)
- Composition and component ingredients
- Manufacturing methods
- Specifications
- Analytical methods
- Container/closure
- Inactivation Kinetics
- Stability studies
Manufacturing Facilities (Stephanie Batliner)
- FDA Inspections
- Type V VMF
Noon | Lunch
12:30 p.m. | Post Approval Maintenance (Stephanie Batliner)
1 p.m. Target Animal Safety Study (Rob Hunter, Ph.D.)
- Site Selection
- Final Study Report
- Monitoring
1:45 p.m. | Break
2 p.m. | Slaughter Authorization (Rob Hunter, Ph.D.)
- Data needed to get a Slaughter Authorization
2:45 p.m. | Navigating the Clinical Effectiveness Technical Section (Beth Kee, D.V.M.)
Introduction to TASS and Clinical (Beth Kee, D.V.M.)
- What will be covered during the Clinical section
- Pilot studies for use in supporting pivotal work
- Key supporting regulatory documents
3:30 p.m. | Pivotal study stage 1: Planning (Part 1) (Beth Kee, Ph.D.)
- Pre-Submission conference
- Protocol meetings
- Study design
4:15 p.m. | Wrap‐up and Concluding Remarks (Rob Hunter, Ph.D.)
4:30 p.m. | Adjourn