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The Graded Case Study module serves as a combined self-study and evaluation mechanism to ensure those receiving the Certificate in Pharmaceutical Medicine have an understanding of nine major areas of knowledge. These include:

• Ethics Committees/IRBs
• Pre-NDA Safety
• Post-NDA Safety
• Clinical Trial Management
• Clinical Trial Design
• Medical Affairs
• Marketing Regulations
• R&D Finance
• Program/Portfolio Management

Each case study is presented as a problem for which a written solution must be developed. This is an open book exercise and the respondent is encouraged to use the solution process as a basis for dialogue with potential mentors, for literature review, and for considering further formal training.

Each case will be evaluated by three pharmaceutical medicine specialists drawn from PERI's pharmaceutical medicine faculty and advisors. Cases will be given a Pass or Fail grade based on specific criteria. Each problem will require 2/3 Pass grades in order to earn the certificate. All case work will remain anonymous.

Questions?
For questions or comments, contact us at Program Director or (703) 276-0178.