Regulatory Affairs in Animal Health Seminar Series
K-State Olathe is hosting seminars designed to provide hot topic information in regulatory affairs and connect industry with regulatory agencies. Upcoming seminars are below.
Antibiotic Stewardship in Animal Health
Antibiotic stewardship continues to be a hot topic in the animal health industry. As a result, the regulatory environment has changed significantly over the last several years with the implementation of Guidance #213 for medicated feed/water additives for food-producing animals. In addition, it is anticipated that more regulatory changes are to come for other product classes. This seminar will discuss the past, current and future issues related to antibiotic stewardship, regulatory implications, and how the industry may adapt in response.
For veterinarians who attend, 4.5 continuing education hours are available.
Mike Apley, professor of production medicine/clinical pharmacology, Kansas State University
Jeff Watts, research director of external innovation – anti-infectives, Zoetis Inc.
Dan Rice, owner, Prairieland Diary
John Butler, CEO, Beef Marketing Group
Nadyne Hagmeier, quality improvement consultant, Kansas Foundation for Medical Care Inc.
Dan Thomson, Jones professor of production medicine and epidemiology, Kansas State University
Bill Flynn, deputy director of the Science Policy Center, FDA Center for Veterinary Medicine
Mike Apley, D.V.M., Ph.D., DACVCP
Professor of production medicine/clinical pharmacology, Kansas State University
CEO, Beef Marketing Group
Bill Flynn, D.V.M., M.S.
Deputy director of the Science Policy Center, FDA Center for Veterinary Medicine
Nadyne Hagmeier, RN
Quality Improvement Consultant, Kansas Foundation for Medical Care Inc.
Elizabeth D. Hermsen, PharmD, MBA, BCPS-AQ(ID), FIDP
Head, global antimicrobial stewardship, global population health, Merck
Global Quality Assurance, Yum! Brands
Owner, Prairieland Diary
Rick Sibbel, D.V.M.
President and owner, Executive Veterinary and Health Solutions
Former executive director, U.S. Food Animal Business Unit, Merck Animal Health
Jeff Watts, Ph.D., M.S.
Research director of external innovation – anti-infectives, Zoetis Inc.
|9 a.m. | Welcome|
|9:05 a.m. | Antibiotic Stewardship in Animal Health: Current Trends |
|9:30 a.m. | Putting a One Health Approach to AMR into Action at Merck|
Elizabeth D. Hermsen
|10:15 a.m. | Antimicrobial Stewardship in Animal Health: Bridging the |
Valley of Death for Innovative Products
|11 a.m. | Break|
|11:15 a.m. | A Storied Program May Not Be Enough|
|Noon | Networking Luncheon|
Lunch provided on-site.
|1 p.m. | Antibiotic Stewardship: Regulated or Voluntary Mandated?|
|1:45 p.m. | Break|
|2:15 p.m. | FDA Efforts to Support Antibiotic Stewardship in Veterinary |
|3:15 p.m. | Panel Discussion|
Moderated panel discussion with all speakers
|4:15 p.m. | Closing Remarks|
CRO-Sponsor Relationships: Best Practices to Improve Efficiency and Regulatory Process Outcomes
Strong sponsor partnerships with contract research organizations, or CROs, can deliver substantial benefits for animal health product development both in efficiency and deliverable quality resulting in faster product approvals. But strategic partnerships require significant investment of effort to develop and maintain. By jointly confronting the barriers to success, and coming to agreement on the needed changes and time commitment required, sponsors and CROs can increase their probability of success.
This seminar will explore the benefits, barriers and factors for success for truly productive partnerships.
Registration and speaker information will be posted in the near future.