Category: Fellows Posters
Postdoctoral industry fellowships provide a Doctor of Pharmacy (PharmD) graduate with a unique opportunity to gain specialized hands-on training for a future in the pharmaceutical industry. Increasing numbers of PharmD graduates pursue careers in the pharmaceutical industry. Over the past 5 years, the number of fellowship positions have grown significantly, totaling over 500 fellows in 2019. The value of PharmD fellowship programs continues to rise as pharmacists seek non-traditional careers. Pharmacists in Regulatory Affairs play a critical role in the drug development and approval process, yet the roles and responsibilities of RA fellows have yet to be thoroughly characterized.
A web-based survey was distributed to Regulatory Affairs fellows within the Industry Pharmacists Organization’s confidential database. Fellows’ functional areas were categorized as Regulatory Affairs if their fellowship program contained the term “Regulatory” in their title. The survey solicited basic information about the fellowship’s structure i.e. duration, academic affiliation, functional area concentration within Regulatory Affairs, and therapeutic areas of focus using “multiple choice” and “Yes/No” questions related to specific activities and experiences typical of a Regulatory Affairs professional within the areas of drug advertising and promotion, labeling, and regulatory strategy. Additional questions described the various types of activities and experiences common to a pharmaceutical industry fellowship. The results of this survey are descriptive in nature.
Of the 24 respondents, 20 (83.3%) were involved in two-year Regulatory Affairs fellowship programs. An equal number of respondents in two-year fellowship programs were first and second-year fellows (41.7%), with 19 respondents (79.2%) reporting an affiliation with an academic institution. Among Regulatory Affairs fellowships, the three most common areas of focus were regulatory strategy (n=18, 75%), labeling (n=8, 33.3%), and regulatory intelligence (n=5, 20.8%). Most fellows (n=20, 83.3%) reported that their fellowship involved a mix of U.S. and Global-focus, with 16.7% (n=4) of fellowships being primarily U.S. focused. Half (n=12, 50%) of regulatory fellows have never attended an advertising and promotion meeting and the majority (n=16, 66.7%) have reviewed advertising and promotion materials. Fifteen respondents (62.5%) have attended a labeling update meeting, with a notable number of respondents having participated in a labeling update (n=14, 58.3%). Eleven respondents (45.8%) reported attendance at a regulatory agency meeting. Over half (13/24, 56.5%) of fellows do not plan to pursue a certification, of any kind, by the completion of their fellowship. However, most fellows have or will have attended a professional conference as part of their fellowship, such as the Drug Information Association Global Annual Meeting (n=17, 70.8%).
PharmD fellows who have a Regulatory Affairs-focused fellowship gain many real-world experiences in the pharmaceutical industry. This cohort suggests that current fellows spend significant time in strategy and labeling across the globe, but specific duties are highly dependent on the specific program. Results from this survey may benefit Regulatory Affairs stakeholders, employers, and current or prospective fellows by (1) providing key insights into anticipated Regulatory Affairs fellowship experiences, and (2) potentially serving to guide future fellows’ development opportunities within established and aspiring fellowship programs.