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College of pharmacy and health sciences
College of Pharmacy & Health Sciences

Pharmacovigilance and Medical Affairs (Focus in Biosimilars and Medical Nutrition Safety)

This program includes Butler University, Fresenius Kabi USA, and the Division of Medication Error Prevention and Analysis (DMEPA) at FDA. This program will have one (1) position available for a two-year term (July 2021 through June 2023).

Fellows will begin with the academic sector at Butler University from July–October 2021. They will then move into the industry sector, working with Fresenius Kabi USA from November 2021–October 2022. Finally, fellows will learn from the regulatory sector, partnering with the FDA from November 2022–June 2023.

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Fellowship Sites:

Butler University College of Pharmacy and Health Sciences

Located in Indianapolis, Indiana, Butler University is a nationally recognized university with six academic colleges.  In 2020, Butler was ranked as the top regional university in the Midwest by U.S. News & World Report, the most innovative among Midwest Regional Universities.  At the Butler University College of Pharmacy & Health Sciences, you will find a community of health professionals committed to excellence. Our programs prepare students and post-graduate learners to become leaders in their chosen fields. Butler University College of Pharmacy and Health Sciences has a variety of post-graduate residencies and fellowships, each designed to strengthen not only the professionals’ specialty expertise, but also enhance teaching abilities in the classroom through faculty direction and mentorship.

Butler University College of Pharmacy and Health Sciences

4600 Sunset Avenue

Indianapolis, IN 46208

www.butler.edu/cophs

 

Fresenius Kabi USA

Fresenius Kabi is a global health care company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition.  From essential injectable medicines to advanced systems used to maintain and protect the nation’s blood supply, our products are used to help care for critically and chronically ill patients.  At Fresenius Kabi we believe that in order to be perceived as a valued, long-term partner by medical professionals, patients, suppliers, government agencies, and the general public, we must strive every day to meet the highest standards of corporate citizenship.

Fresenius Kabi USA

Three Corporate Drive

Lake Zurich, Illinois 60047

www.fresenius-kabi.com

 

United States Food and Drug Administration (FDA)

The Division of Medication Error Prevention and Analysis (DMEPA) within the FDA's Center for Drug Evaluation and Research (CDER) is responsbible for preventing medication errors. As part of the FDA preapproval process for new drug products, we review proposed proprietary drug names, container labels and other labeling, packaging, product design, and human factors protocols and study results to prevent medication errors. For marketed products, we monitor and analyze medication error reports for marketed products to determine if regulatory actions such as labeling revisions or product redesign are needed to address reported errors. We also collaborate with external stakeholders, including patient safety organizations, other regulatory agencies, standards setting organizations, and researchers to understand the causes of medication errors, the effectiveness of interventions to prevent errors, and address broader safety issues that contribute to medication errors.

United States Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

www.fda.gov