Coursework Details

Year 1

Semester 1 (October – December)

The first semester presents many short introductory courses that examine core FDA functions. Fellows will spend about 40% of their time completing these courses.

Coursework:
1. FDA History and Public Policy
2. FDA Law & Regulatory Processes
3. Negotiation and Influencing
4. Communication with the Public and Press
5. Ethics and Decision Making
6. Budgets and Operations
7. Beyond Our Borders
8. Conflict Management Skills
9. Briefing the Boss: Presenting to Senior Executives
10. Building Leadership Credibility

Research:

During this semester each Fellow will work with his or her Preceptor to develop a written research proposal that includes detailed literature review, methods to be used, anticipated outcomes, and skills and techniques to be acquired. During this time, work on the project can begin, even as the formal proposal is developed. The proposal should highlight how the Fellow anticipates the coursework will complement the Fellow's scientific experience.

Semester 2 (January – June)

Coursework:

1. Statistical Methods and Applications
2. Population Science/ Epidemiology
3. Clinical Trial Design and Evaluation

Research:

Students will spend about 65% of their time focusing on the graduate level coursework.

Summer Session 1 (July – August)

Coursework:

1. Investors View of Drug Development: An MBA Course

Research:

Fellows will spend 60% of their time conducting research relevant to their final projects.

Year 2

Semester 3 (September – December)

Coursework:

These courses describe the core functions and science of the Centers/Offices and will be taught by the respective Centers/Offices.

1. Devices and Radiological Health (CDRH)
2. Foundations of Toxicology (NCTR)
3. Understanding Biologic Agents and Their Evaluation (CBER)
4. Understanding Drugs and Their Evaluation (CDER)
5. Food and Nutrition Safety (CFSAN)
6. Surveillance and Operations (ORA) 
7. Animal and Human Health: An Inseparable Link (CVM)
8. Inside the Office of the Commissioner (OC)

Research:

Approximately 70% of the Fellows' time will be spent on their research project. Fellows will give formal research presentations to the Fellowship Committee, other Fellows, and Preceptors for presentation style critiques and feedback.

Semester 4 (January – June)

Coursework:

1. Process Control Engineering and Chemistry
2. Case Studies in Translational and Regulatory Science
3. Risk Assessment / Risk Management
4. Elective

Research:

Approximately 70% of the Fellows' time will be spent on their research project in preparation for the final presentation.

Summer Session 2 (July - October)

The Fellowship ends in October with final presentations of research results to Preceptors, Fellows, and Center staff. In the months leading up to the final presentation, Fellows are expected to focus on finalizing their projects and presentations.

Please note that all courses will be taught at the White Oak Campus in Silver Spring, Maryland. Remote access will be provided for Fellows at NCTR, ORA or other FDA locations.

All courses are instructed at the graduate level, and may require commitment outside of the traditional work schedule.

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