Wednesday, April 30, 2014

Rotation 8 at the FDA

Posted by Mindy Prasad at Wednesday, April 30, 2014

FDA rotation

Rotation block 8 took me to Silver Spring, Maryland and provided the opportunity to learn about the US Food and Drug Administration (FDA). This was by far the best experience I've had all year. The largest contributing factor was that I enjoy the administrative aspect of pharmacy and this rotation was project based and involved a lot of paperwork and meetings – perfect fit! The other contributing factors include having a wonderful preceptor who really tailored my experience to my personal interests, meeting new friends from other colleges of pharmacy across the country, and attending all the student programming provided by the FDA.

My FDA experience was in the Office of Regulatory Policy (ORP) in the Center for Drug Evaluation and Research (CDER). My preceptor was Ellen Molinaro, RPh and she was the only pharmacist in the office I was assigned to. (FYI…Pharmacists make great Project Managers because of the multitasking and interpersonal skills required.) Most of the people in ORP are lawyers. I would start my day at 8:30 am and end at 5:00 pm.  Usually there was at least one student programming event to attend. These consisted of mostly one hour presentations given by pharmacists about the different offices in the FDA. This really provided a nice overview of the role and function of the FDA. The other student programming involved site visits to places like the United States Pharmacopeial Convention (USP), American Society of Health-System Pharmacists (ASHP), American Pharmacists Association (APhA), National Institutes of Health (NIH), and even a tour of the Pentagon. [I didn't actually get to attend the NIH visit because the government had a snow day on the date it was scheduled]

When I wasn't busy attending student programming, I would be working on the projects assigned to me by various people in the office. Many of my projects were related to topics I mentioned to my preceptor that I had personal/professional interest in. I also attended meetings in which these issues were being discussed.
I also assisted with an update to a document to be published in the Federal Register. Each project was interesting and really allowed me to appreciate the intricacies of federal documentation and legal language/terminology. 

I can't say enough how much I enjoyed this rotation. I’m really grateful that we are provided this opportunity at Michigan. 

The pictures below include one with some of the great students I spent a lot of my time with (we are at the APhA headquarters) and one of many historical posters displayed on the White Oak campus.






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