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

Medication Error Pharmacovigilance and Risk Management

This program includes Butler University, Regeneron Pharmaceuticals, and The Office of Medication Error Prevention and Risk Management (OMEPRM) at the USFDA. This program will have one (1) position available for a two-year term (July 2021 through June 2023)

Program Location and Dates

Fellows will begin with the academic sector at Butler University from July–October 2021. They will then move into the industry sector, working with Regeneron Pharmaceuticals from November 2021–October 2022. Finally, fellows will learn from the regulatory sector, partnering with the Food and Drug Administration 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

 

Regeneron Pharmaceuticals

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved medicines and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.

Regeneron Pharmaceuticals

777 Old Saw Mill River Road

Tarrytown, NY 10591

www.regeneron.com

 

United States Food and Drug Administration

Office of Medication Error Prevention and Risk Management (OMEPRM) includes Division of Medication Error Prevention and Analysis (DMEPA) and Division of Risk Management (DRISK). DMEPA looks to minimize medication errors in the U.S. healthcare system. 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. We also 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. DRISK reviews all proposed REMS, REMS modifications, and REMS assessments for all products with approved REMS for conformance with current FDA standards.

United States Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

www.fda.gov