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K-State Olathe
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Olathe, KS 66061-1304

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The Future Vision for FDA's Center for Veterinary Medicine: Opportunities and Challenges in the Regulatory Process


Offered Sept. 21, 2017

About the session

Leaders at the Center for Veterinary Medicine shared how they plan to move forward under new federal leadership. Two roundtable discussions with industry and FDA CVM leaders tackled the opportunities and challenges in the regulatory process for drug discovery and generic drugs. 

This was the first of four seminars tailored to the Kansas City area animal health regulatory affairs community. The series is aimed at providing hot topic information in regulatory affairs and connecting industry with regulatory agencies. 

Featured speaker
Steve Solomon

Steve Solomon, D.V.M.
Director of the Food and Drug Administration's
Center for Veterinary Medicine

Steven Solomon was appointed director of the Food and Drug Administration's Center for Veterinary Medicine in January 2017. He previously served as the deputy associate commissioner for Regulatory Affairs within the Food and Drug Administration's Office of Regulatory Affairs. He joined FDA in 1990 as a veterinary medical officer in the Center for Veterinary Medicine, and has served in various policy and leadership positions in the Office of Regulatory Affairs' Office of Enforcement, Office of Regional Operations and as the Assistant Commissioner for Compliance Policy. He also served in the Office of Global Regulatory Operations and Policy.

Roundtable panelists

• Cindy Burnsteel, director, Division of Therapeutic Drugs for Food Animals

• Matt Lucia, director, Division of Generic Animal Drug

Julie Bailey, deputy director, Division of Manufacturing Technologies

Seminar outline
10:30 a.m. to 12:15 p.m.Industry exchange: "Pioneer Drug Discovery"
Roundtable discussions with industry and FDA CVM leaders about opportunities and challenges in the regulatory process for animal health pioneer drug discovery.
12:15-1:45 p.m.Luncheon/"Future Vision for FDA CVM"
Presentation by Steve Solomon.  
1:45-3:30 p.m.Industry exchange: "Generic Drugs"
Roundtable discussions with industry and FDA CVM leaders regarding opportunities and challenges in the regulatory process for animal health generic drugs.
3:30 p.m.Adjourn 
 
Seminar documents

Regulatory Perspectives: Challenges and Opportunities (pdf)
The presentation that served as the introduction to the seminar.

Keynote presentation about CVM (pdf)
Dr. Steve Solomon's lunchtime keynote. 

Challenges and Opportunities in Animal Health Regulatory Affairs: A Compilation of Industry Roundtable Discussions (pdf)
A summary of the challenges and opportunities for industry and the CVM when it comes to drug discovery and generic drugs in the animal health arena. 

Documents from seminar

Regulatory Perspectives: Challenges and Opportunities (pdf)
The presentation that served as the introduction to the seminar.

Keynote presentation about CVM (pdf)
Dr. Steve Solomon's lunchtime keynote. 

Challenges and Opportunities in Animal Health Regulatory Affairs: A Compilation of Industry Roundtable Discussions (pdf)
A summary of the challenges and opportunities for industry and the CVM when it comes to drug discovery and generic drugs in the animal health arena.