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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  1. Drug Safety and Risk Management Advisory Committee

Drug Safety and Risk Management Advisory Committee Roster

Applying for Membership on FDA Advisory Committees

As part of the Food and Drug Administration's (FDA's) ongoing efforts to recruit qualified experts with minimal conflicts of interest who are interested in serving on FDA advisory committees, FDA is requesting nominations for members to serve on its advisory committees.

Current Number of Vacancies = 2
Note, one or more vacancies may be in the nomination process or a final appointment may have been made.

Chairperson
Vincent Lo Re III, MD, MSCE
Expertise: Infectious Diseases and Pharmacoepidemiology
Term: 6/1/2021 – 5/31/2025
Associate Professor of Medicine and Epidemiology
Division of Infectious Diseases, Department of Medicine
Division of Epidemiology, Department of Biostatistics, Epidemiology, and Informatics
Center for Clinical Epidemiology and Biostatistics
Perelman School of Medicine
University of Pennsylvania
836 Blockley Hall 
423 Guardian Drive
Philadelphia, Pennsylvania 19104

Acting Designated Federal Officer
Michael Gu
Division of Advisory Committee and Consultant Management
Office of Executive Programs
Center for Drug and Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
(301) 796-9001 Fax: (301) 847-8533
E-mail: DSaRM@fda.hhs.gov

Maryann Amirshahi PharmD, MD, MPH, PhD, BCPS, FACMT, FACEP, FASAM, FCP
Expertise: Emergency Medicine, Medical Toxicology, Addiction Medicine, Clinical Pharmacology
Term: 10/31/2024 – 5/31/2028
Professor of Emergency Medicine,
Georgetown University School of Medicine
Department of Emergency Medicine,
MedStar Washington Hospital Center
110 Irving Street NW
Washington, District of Columbia 20010

Michael C. Dejos, PharmD, MBA, BCPS, CHOP, CPPS
Expertise: Patient Safety, Pharmacovigilance, Continuous Improvement
Term: 9/20/2023 – 5/31/2027
System Medication Safety Officer
Methodist Le Bonheur Healthcare
Assistant Professor
University of Tennessee Health Science Center
1211 Union Avenue, Suite 640
Memphis, Tennessee 38104

Sascha Dublin, MD, PhD
Expertise: Internal Medicine, Pharmacoepidemiology
Term: 6/1/2022 – 5/31/2026
Senior Scientific Investigator
Kaiser Permanente Washington Health Research Institute 
1730 Minor Avenue, Suite 1360
Seattle, Washington 98101 

James Floyd, MD, MS
Expertise: Epidemiology, Internal Medicine
Term: 6/1/2022– 5/31/2026
Co-Director, Cardiovascular Health Research Unit
Professor of Medicine
Adjunct Professor of Epidemiology
University of Washington
4333 Brooklyn Ave NE
Seattle, Washington 98195

John B. Hertig, PharmD, MS, CPPS, FASHP
Expertise: Medication Safety
Term: 6/1/2021 – 5/31/2025
Associate Professor 
Department of Pharmacy Practice
Butler University College of Pharmacy and Health Sciences
4600 Sunset Avenue
Indianapolis, Indiana 46208

Krista F. Huybrechts, MS, PhD
Expertise: Pharmacoepidemiology
Term: 6/1/2021 – 5/31/2025
Associate Professor of Medicine and Epidemiology
Harvard Medical School and Harvard T.H. Chan School of Public Health
Division of Pharmacoepidemiology and Pharmacoeconomics
Department of Medicine
Brigham & Women’s Hospital
1620 Tremont Street, Suite 3030
Boston, Massachusetts 02120

Mara McAdams DeMarco, MS, PhD
Expertise: Pharmacoepidemiology
Term: 6/1/2021 – 5/31/2025
Associate Professor
Associate Vice Chair for Research
Department of Surgery
New York University
1 Park Ave, 6-704
New York, New York 10016

Elizabeth Rebo, PharmD, MBA, CPPS
Expertise: Medication Safety
Term: 10/31/2024 – 5/31/2028
Executive Director, Pharmacy Quality and Medication Safety
National Pharmacy Services
Kaiser Permanente
12254 Bellflower Blvd
Downey, California 90242

**Ignacio Rodriguez, MD
Expertise: Drug Development, Clinical Safety and Risk Management
Term: 6/11/2024 – 10/31/2027
Vice President, Global Head Medical Safety
Novartis Pharmaceuticals Corporation
1 Health Plaza
East Hanover, New Jersey 07936

+Jens-Ulrich Stegmann, RN, MD
Expertise: Clinical Development, Clinical Safety, Pharmacovigilance and Risk Management
Term: 6/11/2024 – 10/31/2027
Senior Vice President
Global Head Clinical Safety and Pharmacovigilance, EU QPPV
GlaxoSmithKline (GSK)
20 Avenue Fleming
Wavre, Belgium

* Consumer Representative (Vacant)

**Industry Representative (non-voting)

+Alternate Industry Representative (non-voting)

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