Over the past several years there has been a growing appreciation of the need for training in pharmaceutical medicine in North America, similar to what has been available in the U.K. and several other European countries. Within the profession, there is a heightened awareness of the need for educational programs for new medical professionals entering the pharmaceutical and other medical product(s) environments, as well as for those already experienced but needing training oriented to the evolving development and regulatory environment.

To help fill this void, PERI has developed a Pharmaceutical Medicine Certificate Program to address these special needs for training in basic pharmaceutical medicine. Recognizing that professional learning occurs not only through formal training but through interaction with colleagues, this program features problem-solving-oriented training, as well as opportunities for networking and mentoring with other individuals who are new to the industry and leading experts who can share their personal experiences.

The responsibilities of pharmaceutical medicine flow from the scientific and ethical foundations of the clinical medical arena, as welll as involving a number of new responsibilities and behaviors that are not taught in many professional or graduate schools. Thus, upon entry into a corporate entity devoted to the research and development of drugs and other medical products for regulatory approval and marketing, the pharmaceutical medicine practitioner must rapidly acquire a new body of knowledge and a number of new skills. PERI's program will help pharmaceutical physicians enhance their competency by providing skills such as:

• Navigating the drug and medical product development process and its regulatory framework;
• Development of cost-effective clinical research protocols, and management plans that conform to good clinical practices;
• Creation of program and project budgets;
• Leadership and management of professional research staff and support staff;
• Operating within the team configuration of the complex process of product development;
• Interacting with scientific, regulatory, legal and marketing disciplines in the development, approval, and postmarketing processes;
• Owning the unique responsibility in pharmaceutical medicine to bring the clinical and ethical perspective to the marketing process, particularly with respect to safety issues

The Program consists of two tracks, Basic and Advanced, to meet the learning needs of both new and experienced pharmaceutical physicians. The culminating element of the Program is completion of the Graded Case Study Module, which requires a response to nine case questions that are given a pass/fail grade by a panel of expert graders. Participants in the Program are encouraged to complete their course of study within a two-year period of time.

To begin the Program, please submit the Enrollment Form to PERI so that we may begin tracking your fulfillment of the requirements. Enroll in Program.

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