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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

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

9 a.m. - 4:30 p.m. | Sept. 19

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.

CE Credits

For veterinarians who attend, 4.5 continuing education hours are available.

 



Seminar Documents

Antibiotic Stewardship in Animal Health

Mike Apley, professor of production medicine/clinical pharmacology, Kansas State University

Antimicrobial Stewardship in Animal Health: Bridging the
Valley of Death for Innovative Products

Jeff Watts, research director of external innovation – anti-infectives, Zoetis Inc.

A Storied Program May Not Be Enough

Dan Rice, owner, Prairieland Diary

A Storied Program May Not Be Enough

John Butler, CEO, Beef Marketing Group

Antibiotic Stewardship: Regulated or Voluntary Mandated?

Nadyne Hagmeier, quality improvement consultant, Kansas Foundation for Medical Care Inc.

Antibiotics in food animal production: A journey rather than a destination

Dan Thomson,  Jones professor of production medicine and epidemiology, Kansas State University

 

FDA Efforts to Support Antibiotic Stewardship in Veterinary Settings

Bill Flynn, deputy director of the Science Policy Center, FDA Center for Veterinary Medicine


Speaker Lineup

Mike Apley, D.V.M., Ph.D., DACVCP
Professor of production medicine/clinical pharmacology, Kansas State University

John Butler
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

Mike Morris
Global Quality Assurance, Yum! Brands

Dan Rice
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.


Agenda

9 a.m. | Welcome

Paul Casady 
Executive in residence, professor of practice, K-State Olathe

Mike Apley 
Professor of production medicine/clinical pharmacology, Kansas State University

 

9:05 a.m. | Antibiotic Stewardship in Animal Health: Current Trends
                 and Updates

Mike Apley
Professor of production medicine/clinical pharmacology, Kansas State University

 

9:30 a.m. | Putting a One Health Approach to AMR into Action at Merck

Elizabeth D. Hermsen 
Head, global antimicrobial stewardship, global population health, Merck

Rick Sibbel
President and owner, Executive Veterinary and Health Solutions 
Former executive director, U.S. Food Animal Business Unit, Merck Animal Health

 

10:15 a.m. | Antimicrobial Stewardship in Animal Health: Bridging the
                   Valley of Death for Innovative Products

 Jeff Watts
Research director of external innovation – anti-infectives, Zoetis Inc.

11 a.m. | Break



11:15 a.m. | A Storied Program May Not Be Enough

John Butler
CEO, Beef Marketing Group

Dan Rice
Owner, Prairieland Diary

Noon | Networking Luncheon

Lunch provided on-site.

1 p.m. | Antibiotic Stewardship: Regulated or Voluntary Mandated?

Nadyne Hagmeier
Quality Improvement Consultant, Kansas Foundation for Medical Care Inc.


1:45 p.m. | Break



2:15 p.m. | FDA Efforts to Support Antibiotic Stewardship in Veterinary
                  Settings

Bill Flynn
Deputy director of the Science Policy Center, FDA Center for Veterinary Medicine

3:15 p.m. | Panel Discussion

Moderated panel discussion with all speakers

4:15 p.m. | Closing Remarks

Paul Casady 
Executive in residence, professor of practice, K-State Olathe

Mike Apley
Professor of production medicine/clinical pharmacology, Kansas State University




 

 

 

CRO-Sponsor Relationships: Best Practices to Improve Efficiency and Regulatory Process Outcomes 

1-5 p.m. | Dec. 6

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.