Julio Salazar is the Director for the China Office of the U.S. Food and Drug Administration’s Office of International Programs (OIP). He has previously served as the Assistant Regional Director posted at the U.S. Embassy in Santiago, Chile, covering South America and other countries under FDA’s Latin America Regional Office since August 2014. Mr. Salazar maintains proficiency in regulatory affairs, international inspectional procedures, regulatory compliance procedures and regulatory matters affecting U.S. imports in support of FDA’s international mission. Prior to joining OIP, Mr. Salazar served throughout his career with the U.S. FDA’s Office of Regulatory Affairs ORA. Since 1995 he served as a Consumer Safety Inspector, Consumer Safety Officer and Supervisory Consumer Safety Officer within FDA’s Southwest Import District. From 1999 through 2014 he was in charge of the Laredo Field Office Import Operations and was responsible for all regulatory and investigative operations for the ports of Laredo, Eagle Pass, Del Rio and the Corpus Christi, Texas seaport. He is a graduate of Texas A&M at Kingsville, Texas.
Irene Chan, J.D., M.P.H., is the Deputy Director for the FDA China Office. Most recently, as Associate Chief Counsel in FDA’s Office of the Chief Counsel (OCC), she provided legal counsel on foods and veterinary medicine issues, notably in the areas of biotechnology, third-party certification under the Food Safety Modernization Act (FSMA), and dietary supplements. From 2009-2013, she served as Assistant and Deputy Director of the FDA China Office as part of the original cadre of FDA officials posted overseas. In this capacity she spearheaded cooperative engagements with Chinese government counterparts in areas such as low-acid canned foods, aquaculture, FSMA outreach, and food facility inspections in China. Prior to that, Irene was Special Assistant to the Deputy Commissioner for Policy, where she was responsible for policy analysis and special projects related to guidance, regulation, and legislation development in all of FDA’s product areas. From 2005 to 2006 she performed legal analysis on regulatory issues related to cosmetics and personal care drug products sold over-the-counter as Assistant General Counsel of the Cosmetic, Toiletry, and Fragrance Association (now the Personal Care Products Council). From 2002 to 2005, Irene served as Assistant Chief Counsel in OCC, where she provided legal advice on food safety, dietary supplements, health claims, cosmetics, and food facility registration. Irene received her J.D. from Harvard Law School and her M.P.H. from Harvard School of Public Health.
Dr. Letitia Robinson is the Director for the U.S. Food and Drug Administration’s Office at the U.S. Embassy in New Delhi. Her professional experience has included clinical research, public health legislation and policy development, global health, maternal child health, HIV/AIDS care and treatment, and implementing and providing oversight for programs aimed at increasing access and decreasing disparities in health care. Dr. Robinson has spent over two decades working as a clinician and public health professional to include experience leading programs and activities at the U.S. National Institutes of Health, the Centers for Disease Control and Prevention, and the Health Resources and Services Administration and overseas assignments in Italy and South Africa. The last decade of her experience has focused on efforts to strengthen health systems both nationally and globally. Dr. Robinson has a Doctor of Philosophy in the Health Sciences and both a Master’s and Bachelor’s of Science in Nursing. Dr. Robinson is also a Captain in the U.S. Public Health Service.
Thomas Arista was named Deputy Director of the Office of International Programs (OIP) India Office. Prior to joining OIP, Mr. Arista served as an Office of Regulatory Affairs (ORA) National Expert Investigator in pharmaceutical/ biotechnology and for the past 30+ years has assessed pharmaceutical manufacturing operations worldwide. He continues to work with a number of international standard organizations e.g., American National Standards Institute (ANSI), Association for the Advancement of Medical Instrumentation (AAMI) ISO-13408 Aseptic Processing of medical health products; ISO – 14644 Cleanrooms and associated controlled environments and includes the Parenteral Drug Association (PDA) multiple committees regarding Microbiology and Biotechnology. He has worked with health authorities from around the world e.g., WHO’s International Consultation of Experts to Review the WHO Programme Policy, Process and Indicators for Strengthening NRAs Regulating Health Products and Technologies; the Pharmaceutical Inspection Convention / Scheme (PIC/S) regarding regulatory global compliance, and as the Co-rapporteur of PIC/S Joint Assessment and Inspection (2015) of Comisión Federal para la Protección contra Riesgos Sanitarios/ Federal Commission for the Protection against health risks [COFEPRIS – Mexico]. Mr. Arista has teamed with a number of international inspection teams and regulators e.g., MHRA, EMA, EDQM, WHO, SwissMedic, Santé Canada, Therapeutics Goods Administration (TGA – Australia), China FDA, Japanese Ministry of Health & Welfare, Nigeria National Agency for Food and Drug Administration and Control (NAFDAC).
Mr. Arista continues to teach varied pharmaceutical training courses for ORA Field Investigators, Centers’ Compliance and Review Staff and at a number of FDA India pharmaceutical workshops. Mr. Arista has a BA in Biology from the University of Texas–Arlington.
Ritu Nalubola is the new Director of FDA Europe Office. Prior to taking on this role in July 2018, she served as a Senior Policy Advisor in FDA’s Office of Policy in the Office of the Commissioner. She has advised senior leadership at FDA, the Department of Health and Human Services, and other U.S. government agencies on complex and cross-cutting policy issues, including those related to biotechnology, nanotechnology, food safety, nutrition, and trade-related matters. Most recently, Dr. Nalubola has served as the primary lead for FDA’s efforts, working in conjunction with the broader U.S. government, to modernize the federal regulatory system for biotechnology products, and has been the Agency’s voice on this subject in numerous domestic and international forums. She has led and coordinated FDA’s nanotechnology regulatory policy activities and played a leadership role in establishing specific regulations to implement the FDA Food Safety and Modernization Act, representing and leading FDA delegations in multilateral standards-setting and scientific dialogues.
Prior to joining the Office of Policy in 2009, Dr. Nalubola spent 8 years at FDA’s Center for Food Safety and Applied Nutrition on a range of nutrition and food safety policy matters. Her post-doctoral work with the Johns Hopkins University and later the U.S. Agency for International Development involved setting up international public health programs. She joined FDA in 2001.
Dr. Sandra L. Kweder was named Deputy Director of the Europe Office in the Office of International Programs (OIP), in March 2016. Prior to joining OIP, Dr. Kweder was Deputy Director, Office of New Drugs (OND) in FDA’s Center for Drug Evaluation & Research (CDER), since 2002. In CDER she was an active leader of a number of initiatives, including improvements in the drug review process; modernizing nonprescription drug review; building a systematic drug shortage prevention and management program; patient-focused drug development and clinical outcomes assessment, and; the growth and development of pediatrics and maternal health as standard aspects of drug development.
Dr. Kweder was commissioned in the U.S. Public Health Service upon entering the Uniformed Services University of Health Sciences (USUHS), retiring in 2013 at the rank of Rear Admiral. Following internal medicine training at Walter Reed Army Medical Center she joined the U.S. Food & Drug Administration (FDA) in the Division of Antiviral Drugs to address the growing field of HIV drug development. She has since held a number of positions with FDA in premarket and postmarketing regulation. Until her move to London she was active in medical education as an adjunct faculty member of USUHS, training residents and medical students in Internal Medicine and utilizing her fellowship training from Brown University in Obstetric and Consultative Medicine.
Latin America Office
Katherine (Katie) Serrano is the Director for FDA’s Latin America Office. Katie has over 15 years of experience in the Medical Device field with the last nine years spent in FDA’s Office of In Vitro Diagnostics and Radiological Health, in the Center for Devices and Radiological Health. At the FDA, Katie has worked in a variety of technical, policy, leadership and management positions including: joining the Agency as part of the inaugural class of Commissioner’s Fellows in 2008, working as a scientific reviewer, and serving as the Diabetes Diagnostic Devices Branch Chief and the Deputy Director of FDA’s Division of Chemistry and Toxicology Devices. She also served as the technical and policy lead for the Agency’s efforts related to Laboratory Developed Tests. Ms. Serrano received a Bachelor of Science degree in Biomedical Engineering and a Bachelor of Arts degree in Spanish from the University of Minnesota, Twin Cities. Before working at the Food and Drug Administration, Katie held positions as a regulatory affairs professional at Boston Scientific Corporation and as a Biomedical Engineer at the United States National Institutes of Health, supporting new programs focused on cutting edge technologies in the field of bioengineering.
CDR Michelle Rodriguez currently serves as the Deputy Director for the Latin America Office of the FDA’s Office of International Programs (OIP). Prior to joining OIP, she held various lead and supervisory roles in the areas of regulatory compliance, imports and exports operations, and emergency response activities as Branch Chief within the FDA Center for Tobacco Product’s Office of Compliance and Enforcement and as a compliance reviewer and later post-market team leader in the Center for Devices and Radiological Health’s Office of In Vitro Diagnostics and Radiological Health. Before FDA, CDR Rodriguez served as part of Center for Disease Control’s (CDC’s) National Center for Emerging and Zoonotic Infectious Diseases managing regulatory applications required for stockpiling, and national and international deployment and use of medical countermeasures housed in the US 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, she has deployed and collaborated with various government agencies in support of public health responses impacting the Latin American community. CDR 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 at the CDC.