Issues & Trends in Regulatory Science

Insiders' View of Government

Image of a keyboard with a world and stethoscope on it

  Online: May 8-June 24, 2017 | In-Person: May 22-25, 2017 | 3 credits


Eligibility

This institute is open to current graduate students at the George Washington University (GW), as well as visiting students (e.g., biomedical engineers, medical doctors, J.D. candidates and entrepreneurs in the life-science field) interested in drug and device development and the regulatory aspects of translational research.


Program Description

This summer institute, in the nation’s capital, explores how innovative drugs and devices are developed and regulated. You will have the opportunity to:

  • Visit the Food and Drug Administration (FDA) and the National Institute of Health (NIH),
  • Listen to policy experts and thought leaders explain the ramifications of proposed regulatory initiatives, and 
  • Solve case studies with regulatory and quality professionals from around the world.

The course is an international, multi-disciplinary program organized by the GW School of Medicine and Health Sciences, the GW Law School, and the European Center of Pharmaceutical Medicine (ECPM) at the University of Basel, Switzerland.


Coursework

By the end of the course, students will be able to:

  • Describe how the current regulatory science framework affects the decision-making process for assessing the risks and benefits of medical products.
  • Describe innovative research approaches in the field of regulatory science.
  • Analyze the current healthcare climate and predict its influence on future health care initiatives.
  • Identify regulatory strategies for product submissions and quality systems.
  • Recognize new principles and methodological concepts of epidemiology and health economics and classify their impact on public health.

Cost

  • 3-credit GW course: Tuition (3 credit hours - School of Medicine & Health Sciences) + $230 Program Fee
  • Conference-Only Option: $1600
  • Discounted Conference-Only Option: $950
  • One-Day Conference Pass: $500

Discounts are available to the following individuals who wish to attend the conference only:

If you have questions about qualifying for the discounted price, please contact Ms. Melanie Trask at mtrask@email.gwu.edu.


Meet the Program Organizers & Participants

Program Director

Dr. Daniela Drago, the institute’s program director, is an assistant professor and the director of the Regulatory Affairs Graduate Programs at the GW School of Medicine and Health Sciences.

Partners at ECPM, University of Basel

Dr. Thomas Szucs, is a professor in Pharmaceutical Medicine and Director of ECPM, University of Basel.

Dr. Annette Mollet, is the head of Education and Training at ECPM, University of Basel.

Partner at GW Law School

Dr. Neil Ruiz, is the Executive Director of the Center for Law, Economics, and Finance at GW Law School.

Speakers

The institute will feature speakers from different areas of expertise. 


Registration

To register, please contact Ms. Melanie Trask at mtrask@email.gwu.edu.


More Information

For further details, please visit the program page.