Regulatory Affairs in Animal Health Seminar Series
Throughout the 2017-2018 academic year, K-State Olathe is hosting 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.
The Future Vision for FDA's Center for Veterinary Medicine: Opportunities and Challenges in the Regulatory Process
Sept. 21 | 10:30 a.m. to 3:30 p.m.
Learn how leaders in the Center for Veterinary Medicine plan to move forward under the new federal leadership. Two roundtable discussions with industry and FDA CVM leaders will tackle the opportunities and challenges in the regulatory process for drug discovery and generic drugs.
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.
• 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
• TBD, Office of New Animal Drug Evaluation
• TBD, Office of Surveillance and Compliance
|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.
Registration is $75 per person. Lunch is included with registration. Attendees also will receive a summary of all roundtable discussions and the luncheon presentation following the event.