Terms of Reference

The document describes the terms of reference for a sub-committee of experts to be established under the aegis of ACSoMP for the purpose of reviewing, evaluating, and interpreting post-introduction safety data with new COVID-19 medicinal products in countries.

The COVID-19 ACSoMP Sub-committee (henceforth referred to as COVID-19 sub ACSoMP) will be established in early 2022 for a minimum duration of six months.

Composition

Sub-committee Members

Gerald Dal Pan: Co-Chair ACSoMP, Office of Surveillance and Epidemiology/CDER - US Food and Drug Administration - United States of America

June Raine: Co-Chair ACSoMP - Medicines and Health Care Products Regulatory Agency (MHRA) - United Kingdom

Siti Asfijah Abdoellah: Director for Drug Registration, Directorate of Drug Registration - Indonesian Food and Drug Authority - Indonesia

Stephanie Dellicour: Technical Project Lead - Liverpool School of Tropical Medicine - United Kingdom

Gloria Giraldo: Senior Scientific Evaluator, Marketed Biologicals, Biotechnology and Natural Health Products Bureau, Marked Health Products Directorate (MHPD) - Health Canada - Canada

Parthasarathi Gurumurthy: Director, Pharmacovigilance and Clinical Trials - Botswana Medicines Regulatory Authority (BOMRA) - Botswana

Richard Hill: Senior Medical Officer, International Regulatory Branch, Therapeutic Goods Administration (TGA) - Australian Government Department of Health - Australia

Mulugeta Russom: Eritrean Pharmacovigilance Centre, National Medicines and Food Administration - Ministry of Health- Eritrea

Houda Sefiani: WHO Collaborating Centre - Centre Anti Poison et de Pharmacovigilance du Maroc - Morocco

Esperança Sevene: Faculty of Medicine - Eduardo Mondlane University - Mozambique

Michael Tatley: New Zealand Pharmacovigilance Centre, Division of Health Sciences - University of Otago - New Zealand

EMA representatives

Georgy Genov: Head of Pharmacovigilance, Human Medicines Division - European Medicines Agency (EMA) - The Netherlands

Viola Macolic Sarinic: European Medicines Agency (EMA) - The Netherlands

Corinne de Vries: European Medicines Agency (EMA) - The Netherlands

Global Advisory Committee on Vaccine Safety Representatives

Rita Helfand: Chair GACVS, Senior Advisor for Science - National Center for Emerging and Zoonotic Infectious Diseases Centers for Disease Control and Prevention - United States of America

Dure Samin AKRAM: vice-Chair GACVS, Founder, Honorary Chairperson and President Health, Education and Literacy Program - Pakistan

WHO

Shanthi Pal: Team Lead, Pharmacovilance (PVG) - HQ/MHP/RPQ/REG/PVG - Switzerland

Madhav Balakrishnan: Pharmacovilance (PVG) - HQ/MHP/RPQ/REG/PVG - Switzerland

Noha Iessa: Pharmacovilance (PVG) - HQ/MHP/RPQ/REG/PVG - Switzerland

EunMi Kim: Pharmacovilance (PVG) - HQ/MHP/RPQ/REG/PVG - Switzerland

Smaragda Lamprianou: Pharmacovilance (PVG) - HQ/MHP/RPQ/REG/PVG - Switzerland

Krutika Kuppalli: Medical Officer- HQ/WPE/GIH/EZD - Switzerland

Adi Al-Nusierat:  Access to Pharmaceuticals -EM/RGO/UHS/AMT/ATP - Egypt

Adrien Inoubli: Regional Adviser, Medical Products Quality & Regulation - SE/RGO/HSD/EDM - India

Vanchinsuren Lkhagvadorj: Essential  Medicines and Health Technologies - WP/RGO/DHS/EMT - Philippines

Jean Baptiste Nikiema:  Regional Adviser, Medicine supply, Infrastructure, equipment Maintenance -  AF/RGO/ULC/MIM – Congo

Dorina Pirgari: Access to Medicines and Health Products - EU/RGO/CPS/AMP - Copenhagen

Edgard Rojas Cortes:  Safe Uses of Pharmaceuticals, Biologicals - AM/PAHO - USA

Jinho Shin:  Essential  Medicines and Health Technologies -  WP/RGO/DHS/EMT - Philippines

WHO Collaborating Centre 

Joseph Mitchell: Uppsala Monitoring Centre - Sweden

Boukje Raemaekers: Uppsala Monitoring Centre - Sweden

Rapporteur

John-Joseph Borg: Consultant, Malta