Regulatory
Resources
Selected and recommended by the support group
Clinical development of fixed combination medicinal products:
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Support group members
Dr Samvel Azatyan is a qualified Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 20 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 regulatory systems in low- and middle-income countries, 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 of the Department of Regulation and Prequalification at the WHO’s Headquarters in Geneva, Switzerland.
Prof. Patty J. García, is a Professor at the School of Public Health at Cayetano Heredia University (UPCH) in Lima-Peru and member of the US National Academy of Medicine. She is the former Minister of Health of Peru, former Dean of the School of Public Health at UPCH, and former Chief of the Peruvian National Institute of Health (INS). She is recognized as a leader in Global Health. She is affiliate Professor of the Department of Global Health, at University of Washington and of the School of Public Health at Tulane University. She is actively involved in research and training in Global health, Reproductive health, STI/HIV, HPV and medical informatics. During the pandemic she is leading clinical trials as SOLIDARITY, Convalescent plasma and ivermectin use, and chairs the advising governmental committee on innovations to fight the pandemic.
Dr Hajime Inoue was appointed as a Senior Advisor to the Director-General on 20 September 2015 and Special Representative for Antimicrobial Resistance in the office of the WHO Director-General on 21 November 2016. At WHO he assists the Director-General on high-level political engagements across WHO’s operational clusters. Prior to this appointment Dr Inoue has served as the director for infectious disease control at the Ministry of Health, Labour and Welfare in Japan, where he managed the first major outbreaks of dengue in Japan in recent history.
Dr Inoue started his professional career as paediatric resident in Tokyo and then served as a field officer in the rural Philippines while working for the Maternal and Child Health program. After post-graduate study in public health, specialising in global health, Dr Inoue joined Japanese Ministry of Health, Labour and Welfare in 1996, where he acquired a wide range of technical experience in public health, including hospital management, health insurance, pharmaceutical regulation, infectious disease control, and others.
Dr Inoue has previously worked in the secretariat of the WHO Regional Office for the Western Pacific, and has also served as a member of the governing bodies of WHO, the Global Fund, UNAIDS and IARC.
Lembit Rägo MD, PhD was born in Tartu, Estonia, in 1955. From 1992 to 1999, he was Professor of Clinical Pharmacology at Tartu University. He was the founder and first Director General of the Estonian regulator, the State Agency of Medicines (1991-1999). In December 1999, he joined the WHO Headquarters in Geneva. During 2000-2001, Dr Rägo laid the foundation for the WHO Prequalification of Medicines Programme. Since then the Programme has been the key to getting quality medicines to millions of HIV/AIDS, malaria and tuberculosis patients in developing countries. During his stay in WHO he was also actively involved in creating norms and standards, strengthening regulatory systems and pharmacovigilance. From September 2013, Dr Rägo served as Director and Head of WHO’s newly formed big unit, Regulation of Medicines and Other Health Technologies (RHT), which for the first time in WHO history combined all regulatory issues related to medicines, biologicals including vaccines, and medical devices, into one single unit. In April 2016 he was appointed Secretary-General of Council for International Organizations of Medical Sciences (CIOMS, located in Geneva, Switzerland). Today CIOMS runs many different technical Working Groups related to medical products development, safety and bioethics.
Agnes is an MD and qualified French Paediatrician. She worked as a paediatrician in a paediatric Hospital in Paris, France, then in the pharmaceutical industry, and then moved to the French Medicines Agency. In 2000 she joined the European Medicines Agency (EMA) and was responsible for Orphan Medicines, Scientific Advice, the Small & Medium-sized Enterprises Office, and Paediatric Medicines Sector, implementing the EU Regulation on paediatric medicines. In 2013, she became Head of the Portfolio Board Division, providing oversight of projects for EMA. Since November 2016, she is also the EMA Head of the International Affairs Division.
Dr Nathalie Strub-Wourgaft joined Drugs for Neglected Diseases Initiative (DNDi) in 2009 and is member of the Executive Team as Neglected Tropical Diseases (NTDs) and COVID Director. She holds over 30 years of experience in R&D. As Director of NTDs since 2018, Dr Strub-Wourgaft provides strategic and technical oversight to a wide portfolio of R&D and access plans for therapeutic areas covering Sleeping Sickness, Chagas disease, Cutaneous and Visceral Leishmaniasis, Filaria, & Mycetoma. In 2018, through an international public and private partnership including a scientific platform from Africa, DNDI developed Fexinidazole, its first new chemical entity registered from its portfolio. Since March 2020, Nathalie leads DNDi’s response to COVID-19, as Coordinator of the ANTICOV study Consortium and one of the initiators of the COVID 19 clinical research coalition. She is involved in several working groups dedicated to therapeutics for COVID, with a specific focus on LMIC needs and settings. Prior to her current appointment, Dr Strub-Wourgaft created and held the Medical Director position at DNDi, where she notably developed the organisation’s quality, pharmacovigilance and regulatory activities. Prior to DNDi, Dr Strub-Wourgaft served as Clinical Development Director at Trophos, and held many related roles within Pfizer, Lundbeck and Aspreva. Dr Strub-Wourgaft graduated as Medical Doctor from Necker Hospital, Université René Descartes in Paris in 1983. She co-authored several scientific publications in peer-review journals.