W-16: Precepting Pharmacy Students in a Regulatory Affairs Rotation Program

Poster Presenter

Robert Wittenberg

Director Regulatory Affairs
Astellas
United States

Objectives

The objective of this poster is to share the structure of our Pharmacy Student Rotation Program, examples of student projects, and results from a survey which evaluated the impact/influence of the rotation program.

Method

We characterize the Rotation Program where students learn about the Regulatory Affairs role in an industry setting, with a focus in Advertising & Promotion. Former students completed a survey about their current roles and what, if any, impact the rotation had on them.

Results

We present examples of student projects: a mock enforcement letter (written just prior to an actual FDA letter being issued), final projects evaluating the evolution of enforcement letters and international promotional regulations, and a sample of journal clubs presented. Preliminary survey results show that the rotation increased the students’ interest in industry and played into the majority of their career decisions. Additionally, former students indicated that they would recommend the rotation to future students, and there would be value in expanding the program into an internship and/or fellowship. Finally, nearly a third of the former students are currently working in industry.

Conclusion

Since 2011 Robert Wittenberg and Maninee Patel have hosted pharmacy rotation students to introduce them to industry, Regulatory Affairs, labeling, and advertising and promotion. Projects are related to business needs, current regulatory environment, and support team objectives and research. Responses from the survey have strongly indicated that the rotation was a positive experience, and its preceptors and curriculum were highly effective. Student feedback, at the end of each rotation and from this survey, is vital to shape and improve the program and develop new projects. The feedback received also supports our efforts to scale and mold the program to create a future internship and/or fellowship program. Co-author: Maninee Patel, Pharm.D., Senior Manager, Global Regulatory Affairs