K-State Olathe

Schedule

 

Day 1: Tuesday, Sept. 17

Time

Event

Location
8:30 - 9 a.m. Introductions Overview of Regulations with Kansas State University Olathe Team Great Plains

Keynote

9 - 10:15 a.m. Opening Keynote: An Introduction to Veterinary Biological, Pharmaceutical and Pesticide Regulatory Affairs with Rob Hunter, Norm Brown and Haley Larson Great Plains
10:15 - 10:30 a.m. Break
10:30 - 11:45 a.m. Opening Keynote Continued: An Introduction to Veterinary Biological, Pharmaceutical and Pesticide Regulatory Affairs with Rob Hunter, Norm Brown and Haley Larson Great Plains
11:45 a.m. - 12:45 p.m. Lunch Bistro

Breakout Session One

12:45 - 2 p.m.

USDA Panel Discussion on Reduction on Animal Testing with Martin Tiemann, Terrie Jo Hamtak and Katie Hope; moderated by Doug Shane

Great Plains
12:45 - 2 p.m. Bioequivalence and Biowaivers with David Longstaff and Rob Hunter 221A
12:45 - 2 p.m. CMC Overview with Stephanie Batliner 221B
12:45 - 2 p.m. Initial Submissions to CVB with Byron Rippke and Norm Brown 222A

2-2:15 p.m.

Break

Breakout Session Two

2:15 - 3:30 p.m. CVM Drug Approval Process with Lisa Troutman Great Plains
2:15 - 3:30 p.m. USDA Overview and Licensing with Byron Rippke 221B

3:30 - 3:45 p.m.

Break

3:45 - 4:15p.m.

Speaker Panel and Wrap-up with Rob Hunter and Norm Brown

Great Plains

Social and Networking Opportunities

5:30 - 7 p.m. Subject Matter Expert Dinners (by RSVP only) Local Restaurants

 

Day 2: Wednesday, Sept. 18

Time

Event

Location
8:30 - 9 a.m. Student Services Breakfast Great Plains

Keynote

9 - 10:15 a.m. “John Gamgee, Animal Health Leadership, and You: Lessons learned from two Septembers in history” with Justin Kastner Great Plains
10:15 - 10:30 a.m. Break

Breakout Session Three

10:30 - 11:45 a.m. Ensuring Efficacy: Essential Strategies for Designing Veterinary Clinical Trials with Keith DeDonder Great Plains
10:30 - 11:45 a.m. Industry Perspective of Pharmacovigilance with Will Heeb 221A
10:30 - 11:45 a.m. Outlines of Production with Terrie Jo Hamtak 221B
10:30 - 11:45 a.m. Failure Mode Effectiveness Analysis with TBD 222A

11:45 a.m. - 12:30 p.m.

Lunch with Student Services and Faculty

Bistro

Professional Skills Workshop

12:30 - 2:30 p.m. Professional Skills Workshop: Building & Understanding Emotional Intelligence: Generations & Timeless Leadership with Margie Banach Great Plains
2:30 - 2:45 p.m. Break
2:45 - 4:15 p.m. Professional Skills Workshop: Building & Understanding Emotional Intelligence: Generations & Timeless Leadership with Margie Banach Great Plains

4:15 - 4:30p.m.

Wrap up

Social and Networking Opportunities

5 - 6:45 p.m. Social After Hours Offsite

 

Day 3: Thursday, Sept. 19

Time

Event

Location
8:30 - 9:30 a.m. Industry Resources Panel Breakfast, Moderated by Doug Shane Great Plains
Organizations: Animal Health Corridor, AHI, GADA, BioKansas, Bionexus
9:30 - 9:45 a.m. Break

Breakout Session Four

9:45 - 11 a.m. CRO Selection and Oversight with DJ Rezac and Rob Hunter Great Plains
9:45 - 11 a.m. FDA/EPA Shared Compliance with Haley Larson 221A
9:45 - 11 a.m. USDA CVB Inspection Process with Renee Schnurr 221B
9:45 - 11 a.m. FOIA Discussion and Differences (FDA) with Jennifer Schofield 222A

11 - 11:15 a.m.

Break

 

Breakout Session Five

11:15 a.m. - 12:30 p.m. VICH and International Overview Panel with Martin Tiemann, Rob Hunter, Byron Rippke and moderated by Doug Shane Great Plains
11:15 a.m. - 12:30 p.m. FDA Inspections with Sarah Herring 221A
11:15 a.m. - 12:30 p.m. Deviations, Investigations, Root Cause Analysis, CAPAs with Terrie Jo Hamtak 221B
11:15 a.m. - 12:30 p.m. USDA Pharmacovigilance with John Bare 222A

12:30-1:30 p.m.

Lunch

Case Study Breakouts

1:30 - 3 p.m. Case Study Working Group A: Labeling and the FDA with Rob Hunter, Jennifer Schofield Great Plains
1:30 - 3 p.m. Case Study Working Group C: Writing an Outline for Production (USDA) with Terrie Jo Hamtak and Norm Brown 221B

Close

3 - 3:30 p.m. Closing Remarks and Dismissal Great Plains

 

 

Contact Us

Professional Development Manager
Office Hours
Mon-Fri: 8 a.m. - 5 p.m. CST