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 In this section:

                Office of Global Policy and Strategy

Office of Global Policy and Strategy

                        Countries and Regions Covered by OGPS Offices
          Office of Global Policy and Strategy Offices
          Office of Global Policy and Strategy Leadership
          FDA Overseas Office Directors


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          Office of Global Policy and Strategy
          FDA Overseas Office DirectorsOffice of Global Policy and Strategy FDA Overseas Office Directors
  
  	
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Vanessa-Shaw-Dore
**Director**

**Vanessa Shaw-Dore** is the Director of the China Office in the FDA’s Office of Global Policy and Strategy (OGPS). Ms. Shaw-Dore previously served as Deputy Program Director of the Center for Disease Control’s (CDC’s) Division of Global Health Protection (DGHP) overseeing CDC’s Global Health Security Agenda (GHSA) work in Vietnam. Prior to her time in Vietnam, Ms. Shaw-Dore served in the same office as the Deputy Program Director for CDC’s Democratic Republic of the Congo country office.

Before CDC, Ms. Shaw-Dore served as a Branch Chief in the Health Resources and Services Administration HIV/AIDS Bureau, Division of State HIV/AIDS Programs. In that role, Ms. Shaw-Dore oversaw $490 million in Federal funds in support of Ryan White Part B and AIDS Drug Assistance Program grants for 20 states and U.S. territories, including Washington D.C., Puerto Rico, and the U.S. Virgin Islands. Ms. Shaw-Dore brings 13-plus years of operations and management experience with domestic and international U.S. Government-funded public health programs. She has also led the coordination of high-level interagency programs within global work settings.

Ms. Shaw-Dore holds a Master of Public Health in Community Health Sciences from the University of California at Los Angeles, and a Bachelor of Science in Biology, with a concentration in Molecular Biology from Hampton University in Virginia.



Deputy Director - current vacant

India Office

Dr. Sarah McMullen

Director

**Sarah McMullen, Ph.D.**, is the Director of the India Office in the FDA’s Office of Global Policy and Strategy (OGPS). Her professional experience includes analytical method development and testing for multiple FDA-regulated commodities, establishment inspections, import operations and policy, and foreign office service. Dr. McMullen’s FDA career spans over 15 years working as a chemist, tissue residue specialist, consumer safety officer, and manager. The last five years of her experience focused on international arenas, including import operations and foreign office service. Dr. McMullen has a Doctor of Philosophy in inorganic chemistry from Emory University in Georgia and a Bachelor of Science in chemistry from Emory University in Georgia.



Gregory Smith
**Deputy Director**

Gregory Smith is the Deputy Director of the India Office in the FDA’s Office of Global Policy and Strategy (OGPS). His professional experience includes project management of clinical trials, risk evaluation and mitigation strategies, post marketing, and surveillance initiatives for a global contract research organization (CRO). His FDA career spans over 12 years working as a project manager in CVM’s Office of New Animal Drug Evaluation and as the director of the Special Projects Staff in the Office of Executive Programs. He specialized in complex and mission-critical scientific, regulatory, legislative, and operational issues including user-fee negotiation, supply chain assessment, legislative implementation, organization-wide governance, and portfolio management.

Prior to becoming Deputy Director, he served a year as an international relations specialist for drugs in India. Mr. Smith is a certified project and portfolio management professional and graduated with a bachelor’s degree in communications and public relations from University of Maryland, College Park.

Europe Office

Katie Serrano (2023)
Director

**Katherine (Katie) Serrano** is the director of the Europe Office in the FDA’s Office of Global Policy and Strategy (OGPS). Serrano oversees the FDA’s engagements with European regulatory counterparts and other stakeholders across all FDA-regulated commodity areas in the interest of advancing the FDA’s public health mission.
  
Prior to assuming this role in July 2023, Serrano served six years as the director for the FDA’s Latin America Office based out of San Jose, Costa Rica. During her tenure in Latin America, the office made inroads in encouraging regulatory harmonization and convergence in the region, including the adoption of key medical device international standards involving manufacturing quality. Her office also leveraged the management of two multimillion-dollar cooperative agreements between the FDA and the Interamerican Institute for Cooperation on Agriculture to support the FDA’s international implementation of the Food Safety Modernization Act and the Produce Safety Rule. Under her leadership, the Latin America Office built and expanded regulatory partnerships between the FDA and authorities in both Mexico and Ecuador to strengthen food safety practices and oversight, benefitting consumers locally and in the United States.
 
Serrano began her career with the FDA as part of the 2008 inaugural class of FDA Commissioner’s Fellows and went on to work as a scientific reviewer in the FDA’s Center for Devices and Radiological Health, eventually serving as the chief of the Diabetes Diagnostic Devices Branch and later the deputy director of the Division of Chemistry and Toxicology Devices, before joining OGPS. Prior to working at the FDA, Serrano held positions as a regulatory affairs professional for Boston Scientific Corporation and a biomedical engineer at the National Institutes of Health. She received a Bachelor of Science degree in biomedical engineering and a Bachelor of Arts degree in Spanish, both from the University of Minnesota.

Shannon Thor
**Deputy Director**

Cmdr. Shannon Thoris the Deputy Director of the FDA Europe Office (EO), located in Brussels, Belgium, assuming the role in August 2022. Thor brings 16 years of experience as a pharmacist and public health leader, with more than eight years in senior policy advisor roles at the FDA. As an international policy analyst in the EO, she was responsible for providing leadership and technical expertise on international public health initiatives and U.S.-European Union relations, with a particular focus on maternal health projects such as improving information on the safe use of medicines in pregnancy and during breastfeeding. Her previous FDA experience included roles in the Office of Health and Constituent Affairs and in the Office of New Drugs, where she advised on cross-cutting issues such as over-the-counter monograph reform, drug and device user fee programs, and patient-focused drug development. Since her commissioning in the U.S. Public Health Service in 2015, she has deployed with various government agencies in support of public health emergencies, most notably to support the COVID-19 pandemic response.

Prior to joining the FDA, Thor served as an officer in the U.S. Navy, where she supervised pharmacy operations and directed medication safety programs at military medical facilities in the U.S., Europe, and the Middle East. She earned her Doctor of Pharmacy degree from the University of Illinois at Chicago, her Master of Science in pharmacy policy and regulation from the University of Florida, and her Bachelor of Science degree from the University of Illinois at Urbana-Champaign.

Latin America Office

CDR Michelle Rodriguez

Director

**Capt. Michelle Rodriguez,****Ph.D.**, is the Director of the FDA’s Latin America Office (LAO), organized under the Office of Global Policy and Strategy (OGPS). In her previous role as LAO’s Deputy Director, she led strategic initiatives to transform the FDA-Mexico relationship and increase regulatory cooperation, including spearheading the US-Mexico Food Safety Partnership to improve food safety cooperation. Rodriguez also led regional engagements on whole genome sequencing, supply chain challenges, and regulatory convergence for medical products, including work with multilateral institutions, governments, and forums. She is also at the forefront in implementing a federal mandate to regulate U.S. shrimp imports from its largest providers, which includes Ecuador. Before joining OGPS, Rodriguez held various leadership and supervisory roles in the areas of regulatory compliance, import and export operations, and emergency response activities. She served as Branch Chief within the FDA Center for Tobacco Product’s Office of Compliance and Enforcement and was also a compliance reviewer and later a post-market team leader in the Center for Devices and Radiological Health’s Office of In Vitro Diagnostics and Radiological Health. Before joining the FDA, Rodriguez was at the Center for Disease Control and Prevention’s (CDC) National Center for Emerging and Zoonotic Infectious Diseases, managing both the regulatory applications required for stockpiling, and also the national and international deployment and use of medical countermeasures in the U.S. Strategic National Stockpile. She also supported CDC’s emergency preparedness, response, and outbreak activities in Latin America. Since her commissioning in the U.S. Public Health Service in 2011, Rodriguez has deployed and collaborated with various government agencies in support of public health responses impacting the Latin American community. Rodriguez holds a microbiology degree from the University of Puerto Rico. She completed her doctoral studies in immunology at the University of Florida and later completed a postdoctoral ORISE fellowship in virology at the CDC.

                                                                                  Content current as of:
      01/17/2024Office of Global Policy and Strategy

          
                        Countries and Regions Covered by OGPS Offices
          Office of Global Policy and Strategy Offices
          Office of Global Policy and Strategy Leadership
          FDA Overseas Office Directors


                        Office of Global Operations
          Office of Communications, Evaluation, and Logistics
          Office of Trade and Global Partnerships
 
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