Regulatory Pharmaceutical Fellowships

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The purpose of the Regulatory Pharmaceutical Fellowship is to expose selected candidates to one of two tracks focused on the medical and regulatory aspects of drug information dissemination or marketing. The program serves to maintain and enhance a scientific link among the Food and Drug Administration (FDA), academia, and the pharmaceutical industry.

The program also provides an opportunity for the fellow to develop an understanding of the process and practices of the FDA and the pharmaceutical industry in the delivery of drug information and the regulatory oversight of prescription drug marketing practices.

The fellowship will allow participants to have an opportunity to experience careers in the area of academia, government, and industry. Graduates of the program will be qualified to pursue career opportunities in pharmaceutical industry, FDA or academia.

The fellowship is a two-year program consisting of:

  • A nine-month rotation with the Center for Drug Evaluation and Research (CDER) (Silver Spring, MD)
  • A nine-month rotation at Eli Lilly and Company (Indianapolis, IN) or Ortho-McNeil Janssen Scientific Affairs, LLC (Raritan, NJ) and
  • A six-month rotation with Purdue University School of Pharmacy and Pharmaceutical Sciences (Indianapolis, IN)

The program has two tracks available:

  • One drug information track, offering two-year positions annually  
  • One drug advertising and promotion track, offering two-year positions biennially

Regulatory Pharmaceutical Fellowships

Purdue University, Clarian Health, and Wishard Health Services
Indianapolis, IN

The six-month academic drug information portion of the Regulatory Affairs Fellowship will provide the fellow with exposure to academia and the different functions and responsibilities of institutional-based drug information centers. The program with Purdue University offers experience with the provision of drug information including formulary management, adverse drug event reporting, medication safety, and drug-use policy in conjunction with Wishard Health Services and Indiana University Health. In addition, the fellow gains significant experience in academia, providing didactic and experiential training to Purdue University student pharmacists.

Eli Lilly and Company
Indianapolis, IN

The nine-month rotation at Lilly will provide an opportunity for the fellow to develop skills in the practice of medical information in the industry setting. The fellow will complete projects related to the delivery of medical information to providers, patients, and payers. The program offers experience with Health 2.0 (the intersection between healthcare and technology) and Lilly’s strategy and use of e-channels to communicate medical information to customers. The fellow gains knowledge and understanding of the Health 2.0 space, Lilly's thoughts and strategies as it relates to scientific and medical opportunities, and the importance of networking and intra-collaboration.

Food and Drug Administration
Silver Spring, MD

The FDA rotation offers opportunities to gain experience providing drug information to health care professionals, consumers, and industry from a regulatory position. The fellow is responsible for responding to drug information requests, mentoring pharmacy students and providing support for various FDA-Center for Drug Evaluation and Research (CDER) initiatives. The program allows the fellow to attend Advisory Committee meetings; interact with pharmacists throughout FDA; utilize tools such as Twitter, listservs and podcasts to communicate the latest drug information; and become familiar with the Federal, Food, Drug, and Cosmetic Act, Federal Register, and the Code of Federal Regulations.
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Drug Advertising and Promotion Track

Purdue University – Department of Pharmacy Practice, Indianapolis, IN

Wishard Health Services, Indianapolis, IN

Indiana University Health, Indianapolis, IN

The six-month academic portion of the Pharmaceutical Drug Development Fellowship will provide the fellow with exposure to academia and the different functions and responsibilities of institutional-based pharmacy administration. The program offers experiences in formulary management, medication safety, and drug-use policy in conjunction with Wishard Health Services and Indiana University Health. In addition the fellow gains significant experience in academia providing didactic and experiential training of Purdue University students.

Eli Lilly and Company
Indianapolis, IN

The 9-month rotation will provide an opportunity for the fellow to develop skills to evaluate prescription drug advertising and promotion to healthcare professionals and consumers through different media such as print, television and the Internet. The fellow will be mentored by a member of the Regulatory Advertising and Promotion staff, and be responsible for providing regulatory guidance and support to the brand marketing teams. In addition, the fellow will provide support to the Regulatory Advertising and Promotion group by participating in a variety of departmental projects. Exposure to other areas of the pharmaceutical industry and professional networking will also be a major focus of the nine-month experience.

The U.S. Food and Drug Administration, Division of Drug Marketing, Advertising and Communications
Silver Spring, MD

The nine-month rotation will offer the fellow a unique opportunity to gain experience in the government promotional review process. The fellow will become familiar with sections of the Federal Food, Drug, and Cosmetic Act pertaining to prescription drug advertising and promotion and relevant FDA Guidance documents. The fellow will assist in the review of promotional materials, evaluate draft product labeling (package inserts), research and evaluate industry complaints, and work with the trade name review group or the patient-related outcome claim evaluation team. The fellow may attend both departmental and interdepartmental meetings. The fellow will be mentored by a senior member of DDMAC and the two will work collaborate to develop departmental project(s) tailored to the fellow’s interests. Exposure to other areas of the agency and professional networking will also be a major focus.
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Application Process

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