Working group objectives
Facilitate rapid and joint protocol reviews and consideration of relevant import licenses by national regulatory agencies, through joint reviews for clinical approval and registration.
Working group members
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 is part of the DNDi team since 2009, and holds over 35 years of experience in R&D and public health since the past 11 years. Dr Strub-Wourgaft is currently the Director of Neglected Tropical Diseases (NTDs) and acting ANTICOV Lead at DNDi. 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, filarial diseases, mycetoma, and COVID-19, answering unmet medical needs for neglected populations. Prior to her current appointment, Dr Strub-Wourgaft held the Medical Director post at DNDi, where she oversaw clinical development of the DNDi kinetoplastid and mycetoma portfolio, and was also responsible for developing and supervising the organization’s quality, pharmacovigilance, and regulatory activities. Before her time at DNDi, Dr Strub-Wourgaft served as Clinical Development Director at Trophos, and held many related roles with Pfizer, Lundbeck, Asperva, and CROs. Dr Strub-Wourgaft graduated as Medical Doctor from Necker Hospital, Université René Descartes in Paris in 1983.
A Clinical Research Coalition Against COVID-19
- FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency
- AVAREF Strategy and Guidance for Emergency Preparedness
- CIOMS statement: Medicines assessment during public health emergencies needs good science, best practices and proper communication
- Drug-induced liver injury (DILI): Current status and future directions for drug development and the post-market setting
- Considerations for Regulatory Oversight of Clinical Trials in the COVID-19 Pandemic by PAHO
- ICMRA statement on clinical trials
- ICMRA statement for healthcare professionals: How COVID-19 vaccines will be regulated for safety and effectiveness
- Déclaration de l’ICMRA pour les professionnels de la santé : Comment l’innocuité et l’efficacité des vaccins contre la COVID-19 seront réglementées | International Coalition of Medicines Regulatory Authorities (ICMRA)
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