Seminar 7: Animal Pharmaceuticals Supply Chain Interruptions
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.
Documents/Presentations
Animal Pharmaceutical Supply Chain Interruptions
Jeanne Greenwald, director regulatory affairs, Merck Animal Health
Drug Shortages: CVM Perspective
Arnel Peralta, drug shortage coordinator, FDA CVM
Julie Bailey, division of manufacturing technologies, FDA CVM
Drug Supply Interruption Panel: Some Day-to-Day Examples
Jeanne Greenwald, director regulatory affairs, Merck Animal Health
Industry Perspectives on Interruption Mitigation and Opportunities to be Proactive
Jeanne Greenwald, M.S., RAC, director regulatory affairs, Merck Animal Health
Brian Johnson, Ph.D., executive director and head of the API Technology and Portfolio Management Group, Merck Animal Health
Mike Mlodzik, associate director, Global Regulatory Affairs CMC Pharmaceuticals, Boehringer Ingelheim Animal Health
Drug Shortage: PDA's Approach to Prevention and Management
Chris Smalley, compounding pharmacy advisor, Val Source
Animal Pharmaceutical Supply Chain Interruptions: Why Interruptions Occur and Best Practices for Mitigation
Mike Mlodzik, associate director, Global Regulatory Affairs CMC Pharmaceuticals, Boehringer Ingelheim Animal Health USA Inc.
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.