Preceptor: Stephen Kagan, MD
Coordinator: Cristina Zannikos, cristina.zannikos@pfizer.com
Tel: 212-733-7546
Course Code: 21-02

Prerequisites: None

FOR NYU GROSSMAN SCHOOL OF MEDICINE MATRICULATED STUDENTS ONLY

Pharmaceutical Medicine Elective Syllabus

Description

This elective is a full-time 4-week elective. This is a collaborative effort between the Office of Medical Education at the NYU Grossman School of Medicine, and the Medical Director at Pfizer Inc. It is based at the Pfizer Global headquarters located at 235 East 42nd Street, NY, NY.

All students will participate in a core module that covers the essentials of all pharmaceutical medicine disciplines. In addition, they will be given a further choice of three pharmaceutical medicine disciplines out of five offered (medicines regulation, drug safety surveillance, clinical pharmacology, clinical development, medical affairs) in any of seven therapeutic areas (cardiovascular health, diabetes, pain, women’s health, urology, substance use disorders and respiratory). Further therapeutic areas (e.g., oncology) and additional pharmaceutical medicine disciplines (e.g., epidemiology, health economics) may be available upon the student’s request, subject to availability.

The elective will be organized to include formal and informal educational sessions, project work and project team meetings, and interactive meetings with the preceptor. The elective will culminate in the completion of a project, paper or presentation, to be determined during the first week.

Objectives of the Elective

This elective will provide exposure to fundamental pharmaceutical medicine disciplines in theory and in practice with real life examples of day to day medical work in a global pharmaceutical company. Upon successful completion the student will be able to demonstrate understanding in the following areas:

1. Legislative framework in development, registration & monitoring of medicines, US and global Regulatory Agencies.

2. United States Prescribing Information (USPI) - What is it and how does it come to be?
3. Adverse Event reporting and Medical assessments in drug safety reporting
4. Communication of safety issues
5. General principles of drug development and human research conducted with adequate human subject protection and using the accepted principles of conducting research in human subjects.
6. Healthcare environment of pharmaceutical medicine: legal & regulatory framework, payor structure/processes, New Integrated Delivery Network etc.

Key Responsibilities of the Student during the Elective

1. Adhere to the course schedule and attend all teaching sessions, class work, presentations and meetings during the full time 4-week program. Students should not miss more than one day during this elective. Students should contact Cristina.Zannikos@pfizer.com regarding concerns about absences in advance of starting the elective.

2. Provide, at the end of the course, a completed project, paper or presentation on a topic agreed with the preceptor.

Didactic Program

The 4-week schedule will include but will not be limited to regular 1:1 and small group teaching sessions with the preceptor and other Pfizer professionals, presentations, and shadowing experiences. Course materials will be provided and a final project, paper or presentation by the student will be required for successful completion of the elective.

Method of Evaluation

Evaluation will be based upon attendance, active participation and engagement as well as the final project, paper or presentation. Based on the formative and summative evaluations received from your preceptors at Pfizer, a pass/fail grade with commentary will be assigned by the NYU Grossman School of Medicine.

Scheduling Information

Electives are offered year-round and start/end dates will be determined based on student availability as well as Pfizer capacity.

Students per period: 10
Report To: Dr. Nikolas Karkanias, nikolas.karkanias@pfizer.com, 973-216-9751
Duration: Four weeks full time
Offered: All year except July and August