The Regulatory Science Summer Institute is an elective course open to current graduate students at the George Washington University, as well as visiting students (e.g., biomedical engineers, medical doctors, J.D. candidates, and entrepreneurs in the life-science field, etc.) interested in drug and device development and the regulatory aspects of translational research.
The Summer Institute is an international, multi-disciplinary program organized through collaborations between 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. Located in the nation’s capital, the Summer Institute is a forum for students to explore how innovative drugs and devices are developed and regulated.
Students 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.
- Solve case studies with regulatory and quality professionals from around the world.
2017 Summer Institute
Issues & Trends in Regulatory Science
Online: May 8-June 24, 2017 | In-Person: May 22-25, 2017
The Issues & Trends in Regulatory Science institute will feature several guest speakers from different areas of expertise. Read more.
- Alpert, Susan, Former Chief Regulatory Officer at Medtronic
- Avellanet, John, Managing Director & Principal, Cerulean Associates LLC
- Barrueta, Anthony, Senior Vice President of Government Relations for Kaiser Foundation Health Plan, Inc.
- Bobka, Marlene, President, FOI Services, Inc.
- Blackwood, Elizabeth, Chief Quality Officer and Vice President, Pharmaceuticals Quality, Johnson & Johnson
- Brooks, Paul, Senior Vice President, Healthcare Solutions, BSI America
- Childs, Blair, Senior Vice President of Public Affairs, Premier Inc.
- Dunham, Bernadette, Visiting Professor at GW and Former Director, Center for Veterinary Medicine, US FDA
- Lopert, Ruth, Deputy Director, Pharmaceutical Policy and Strategy, Pharmaceuticals and Health Technologies Group, Management Sciences for Health
- Mansour, Mark, Partner, Mayer Brown LLP
- Morton, Michael C., Vice President, Corporate Regulatory Affairs, Medtronic, Inc.
- Niedelman, Steven, Lead Quality Systems & Compliance Consultant, King & Spalding LLP
- Nusgart, Marcia, Executive Director, Alliance of Wound Care Stakeholders
- Racic, Amra, Principal Regulatory Affairs Policy & Advocacy Specialist at Medtronic
- Singer, Nancy, President, Compliance-Alliance
- Tillman, Donna-Bea, Senior Consultant (Medical Devices), Biological Consulting Group
- Weichold, Frank F., Director, Office of Critical Path and Regulatory Science Initiatives in the office of the Chief Scientist and the Office of the Commissioner for the FDA
- Wetzel, Matthew, Vice President & Assistant General Counsel of the Advanced Medical Technology Association,
- White, Christopher L., Senior Executive Vice President, General Counsel and Secretary, Advanced Medical Technology Association (AdvaMed)
- Yocher, Robert E., Senior Vice President of Regulatory Affairs, HeartWare International Inc.
Click here to register for the Summer Institute.
Summer Institute 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:
- Academics: Available to those with a current full-time position at an educational institution.
- NGOs: Available to employees of registered NGOs only.
- Governmental organizations: Available for employees of a local, regional, national, or federal government organization.
- Advisory Boards Organizations: Available to those with a current full-time position at an organization, which has an employee serving in the Advisory Board of the Regulatory Affairs Master’s Program at GW, or in the Advisory Board of the Master of Medicines Development (MDD) at the University of Basel, Switzerland.
For questions about qualifying for a discounted rate, please contact Ms. Melanie Trask at firstname.lastname@example.org.
Regulatory Affairs Program Director
- Dr. Daniela Drago, the program director, is a GW faculty member and has a strong background in the pharmaceutical and medical device industry.
Partners at ECPM, University of Basel
- Dr. Thomas Szucs, is 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. He leads a new entrepreneurship initiative at the Law School.
2016 Summer Institute
- About the 2016 Regulatory Science Summer Institute
- 2016 Summer Institute Agenda
- Student Reflection: 2016 Summer Institute
Learn More To learn more about GW’s Master’s in Regulatory Affairs program, contact an admissions advisor today at (844) 386-7323 or click here to request more information.