Council of Regulators

Dr. Shari Targum has over 30 years of clinical, industry and regulatory experience. She began her FDA career in 1999 as a Medical Officer and then Team Leader in CDER's Division of Cardiovascular and Renal Products and she has held positions of increasing authority in CDER and CBER over the past two decades. During her tenure at FDA, she has been a frequently invited speaker and an active participant in many councils/committees and working groups. Dr. Targum received her M.D. from the NYU Grossman School of Medicine and an M.P.H. from the Johns Hopkins School of Public Health.

Diogo Penha Soares is Deputy Director at the Brazilian Health Regulatory Agency's Presidency. He joined Anvisa in 2005, having carried out activities related to post-market surveillance, health services regulation and international affairs. Regarding the latter, he was one of Anvisa's representative in the ICH Management Committee and IPRP vice-chair.

Mr Hiiti Sillo is the Unit Head, Regulation and Safety within the WHO Department of Regulation and Prequalification. In this role, he coordinates WHO strategies for strengthening national and regional regulatory systems for medical products, including promoting regulatory harmonization, convergence, networking, work-sharing and reliance. He was previously the Team Lead, Regulatory Systems Strengthening within the Regulation and Safety Unit of WHO. Before joining WHO in January 2018, he was the Director General of the Tanzania Food and Drugs Authority (TFDA), now the Tanzania Medicines and Medical Devices Authority (TMDA). Mr Sillo is a Pharmacist and holds an MSc in Pharmaceutical Services and Medicines Control.

Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 24 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration, convergence and harmonization, as well as regulatory capacity building and facilitation of products introduction in the countries. Dr Azatyan has also led various projects aiming at development of national regulatory systems, as well as the development and implementation of the concept of reliance in regulation of medical products. Dr Azatyan is currently leading the Regulatory Convergence and Networks Team at the WHO's Headquarters in Geneva, Switzerland.

Dr Alison Cave is Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency (MHRA), with responsibility for the safety of medicines and medical devices in the UK. She holds a BSc (Hons) and PhD from the University of London and has extensive academic and regulatory experience, including roles at both the European Medicines Agency and at the MHRA. Her previous positions include Head of Cellular, Developmental and Physiological Sciences at the Wellcome Trust and an Industrial Strategy Challenge Fund Director at UK Research and Innovation.

Prior to joining DIA in 2023, Fathallah was the Operating Officer and EVP at Ortho Clinical Diagnostics, accountable for Operations, Post Market Product Science and Engineering, Regulatory, Quality, Medical, Clinical, Scientific Affairs, and Process Excellence. Before joining Ortho, he held Executive and Senior Leadership roles in Research and Development, Operations, and Regulatory Medical and Clinical Affairs at Avantor, Danaher, Pfizer, Hospira, and Abbott Laboratories. Fathallah holds a Master’s and Bachelor of Science degrees in Mechanical Engineering from the Univ. of Wisconsin-Madison and an MBA from the Kellogg School of Management at Northwestern University.

Sabine Haubenreisser is a pharmacologist with special interest in scientific cooperation and regulatory convergence to the benefit of public health, through engagement with external stakeholders, the European network of experts and international partners and regulators. She has held positions at EMA in scientific divisions, international affairs and (currently) stakeholder engagement. She served 5 years as EMA Liaison Official at the US FDA, where she facilitated cooperation between the European Regulatory Network and the FDA. During this time, she oversaw completion of the EU/US Mutual Recognition Agreement on GMP inspections and development of new platforms for cooperation such as on patient engagement, rare diseases and pharmacometrics.

Juhye Kang is the Director General of the Drug Evaluation Department at the Ministry of Food and Drug Safety (MFDS) in South Korea. She holds a bachelor's degree in pharmacy and a Ph.D. in pharmacy from Dongduk Women’s University, as well as a master's degree in microbial pharmaceutical chemistry from Seoul National University. Dr. Kang has held numerous leadership roles within the MFDS, including Director of the Blood Products Division, Director of the Herbal Medicine Research Division, and Director of the Planning & Coordination Division. She played a pivotal role during the COVID-19 pandemic as Head of the Clinical Evaluation Team for vaccines at the COVID-19 Emergency Response Support Headquarters.

Yee Hoo Looi, PhD, is Deputy Director of Therapeutic Products Branch of the Health Products Regulation Group, Health Sciences Authority (HSA), which administers the regulation and pre-market evaluation for drug registration in Singapore. Dr. Looi started his HSA career as an evaluator for both clinical and toxicology review, and currently leads non-clinical evaluation and helps to oversee benefit-risk assessment for marketing approval. Prior to joining HSA, he conducted safety assessments of drug candidates as an industry pharmacologist. Dr. Looi earned his PhD in Pharmacology from the University of Strathclyde (United Kingdom), and completed his post-doctoral training, focusing on heart failure research, at King’s College London.

Dr. Jörg Schläpfer, PhD is the Head of Communication and Networking and Member of the Management Board of Swissmedic. He studied Veterinary Medicine at the University of Berne, completing his studies in 1991. After obtaining the title of Doctor of Veterinary Medicine, completing his PhD and undertaking 12 years of academic research, he was employed by a number of companies in various roles within the pharmaceutical industry from 2002 to 2015. Since the end of 2015, Jörg Schläpfer has been Head of Division Process Development and Support in the Authorisation sector at Swissmedic as well as Deputy Head of the sector.

Sophie Sommerer is the Director General of Health Canada’s Marketed Health Products Directorate. She is responsible for post-market surveillance of a range of health products, including pharmaceutical and biologic drugs, natural health products and medical devices. From 2016 to 2026, Sophie held various executive roles in pre-market and post-market regulation of health products, following approximately 10 years in health promotion policy at the Public Health Agency of Canada. Sophie has been a member of the DIA's Council of Regulators since 2024 and was a member of the DIA's Regional Advisory Committee for the Americas from 2022 to 2024.

Yoshiaki Uyama, PhD, is Director, Office of Medical Informatics and Epidemiology, for the Pharmaceuticals & Medical Devices Agency (PMDA), Japan. His experience in the safety review and assessment of new drugs for PMDA includes serving as the Review Director; as International Conference on Harmonisation Technical Coordinator; as ICH E15 and E16 topic leader; as Division Director, Regulatory Science Research; as Division Director, Review Planning and Pharmaceutical Affairs Consultation; as Director, Division of Epidemiology; and as Rapporteur of the International Conference on Harmonisation E17 Expert Working Group. Dr. Uyama earned his PhD from Nagoya City University and his post-doctoral research focused on promoting science within Japan.