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K-State Olathe

K-State Olathe
22201 W. Innovation Dr.
Olathe, KS 66061-1304

913-541-1220
913-541-1488 fax
olatheinfo@k-state.edu

Regulatory Affairs in Animal Health Seminar Series

Upcoming seminar in the Regulatory Affairs in Animal Health Seminar Series:

Animal Pharmaceuticals Supply Chain Interruptions

An Interactive Workshop on Why Interruptions Occur and Best Practices for Mitigation

Sept. 26 | 9 a.m. to 4:30 p.m.

Seminar Overview

Supply chain interruptions can cause significant impact for the health and wellbeing of animals. In the case of medically necessary products in which there are no available replacements, these can cause even greater impact —both to welfare and publicity.

A significant contributor to this problem is the complexity of the regulatory environment that exists both domestically and abroad. Another contributor to this problem is the limited number of approved suppliers that exist globally. While maintaining product quality is paramount, identifying and reducing supply chain risks is key for animal health industry sustainability, but also the health and wellbeing of pet and food animal drugs and vaccines.

This hands-on workshop will utilize current industry case studies to engage participants in analyzing supply chain interruptions to understand why they occur; what can be done to prevent them; and ways to enhance communication in the process.

Attendees will also hear from a variety of experts on the topic from Industry, CMOs, K-State and FDA CVM to share animal health supply chain best practices, as well as discuss the advantages of risk mapping as a mitigation tool.

Format

The morning session will be a variety of presentations on supply chain interruption examples from a wide variety of industry speakers and best practices for avoidance. The afternoon session will feature interactive case studies that will highlight multiple roles in maintaining supply chain integrity.    

Register now

 


 Agenda

8 a.m. | Registration and Networking

 

9 a.m. | Welcome and Introductions

Gary Anderson, director, Animal Health and Food Safety Institute, K-State Olathe

 

9:15 a.m. | Overview Presentation

Jeanne Greenwald, director regulatory affairs, Merck Animal Health

 

9:45 a.m. | Industry Perspectives on Interruption Mitigation and Opportunities to be Proactive

Jeanne Greenwald, director regulatory affairs, Merck Animal Health

Mike Mlodzik, associate director, Global Regulatory Affairs CMC Pharmaceuticals, Boehringer Ingelheim Animal Health USA Inc.

TBA - Quality Dept Representative

TBA - Technical Operations Representative

 

11 a.m. | Networking Break

  

11:15 a.m. | FDA CVM Drug Shortage Report Overview

Arnel Peralta, D.V.M., drug shortage coordinator, Office of Surveillance and Compliance

Julie Bailey, Ph.D., deputy director, Division of Manufacturing Technologies, Office of New Animal Drug Evaluation

 

Noon | Lunch

Lunch will be provided on-site.

 

1 p.m. | Case Study Scenario #1- Animal drug stopped due to API supplier non-compliance

Case study overview with one page summary handout.

 

1:30 p.m. | Case Study Scenario #2- Animal drug stopped due to non-compliance of manufacturing facility

Case study overview with one page summary handout.


2 p.m. | Round Table Discussions

• What best practices do you already implement?

• What barriers exist to mitigating supply chain interruptions?

• What new best practices could be helpful to your company?

2:30 p.m. | Networking Break



3 p.m. | Product Risk Mapping/Management Tools

Chris Smalley, compounding pharmacy advisor, Val Source

Risk based tools for the prevention and management of human drug shortages will be presented as well as applications for animal health.

3:45 p.m. | Risk Mapping Exercise

Attendees will be provided with risk based tools and begin the risk identification for animal health products.

4:15 p.m. | Conclusion and Next Steps

Gary Anderson, director, Animal Health and Food Safety Institute, K-State Olathe

4:30 p.m. | Session Ends



About the Series

Kansas State University Olathe, in partnership with BioKansas, is hosting a seminar series designed to provide the latest information about regulatory affairs in animal health.

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