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Improving the detection, analysis, and reporting of harms in medicines and devices – Statement from the 2019 4Es Forum

Delegates from an international conference © University of Oxford

The 4Es forum took place on 7 October – 9 October 2019 in stunning Erice, Sicily. It was a collaboration between the Uppsala Monitoring Centre, WHO’s Programme for International Drug Monitoring and the Centre for Evidence-Based Medicine, University of Oxford; and was hosted and funded by the Ettore Majorana Foundation and Centre for Scientific Culture (EMFCSC).

What are the 4Es?

Exploring, Enhancing and Empowering safer Medicines in Erice!


We know that the current approval of medicines has shortcomings; problems have led to many ineffective available drugs, and postmarketing has often not detected problems before harms have occurred. This three-day workshop aimed to determine how we can make progress together. There was time for talking, listening and discussion to take forward initiatives. Each day had a specific focus: premarketing approvals (day 1); post-licensing (day 2) and communication of harms (day 3), with the morning about the problems and the afternoon looking towards the solutions.


The statement was developed by conference delegates: download and read the statement here.



We were delighted to welcome the following speakers and workshop facilitators, and thank them for their valuable contributions:

Asger San Paludan-Muller, Nicholas DeVito, Peter Gotzsche, Tom Jefferson, Catherine Riva, Jeff Aronson, Gilles Mignot, Florence van Hunsel, Joan-Ramon Laporte, Luca Li Bassi, Lars Jorgensen, David Healy, Georgia Richards, Kath Sansom, Daniele Sartori, Anthony Cox, Bruce Hugman.


The Steering Committee included Georgia Richards (Chair), Dr Rebecca Chandler, Professor Carl Heneghan, Dr Marie Lindquist and Ruth Davis.


Dr Anthony Cox, University of Birmingham
Asger Sand Paludan-Müller, University of Copenhagen
Bruce Hugman, UMC
Prof Carl Heneghan, CEBM Oxford
Catherine Riva, Re-Check Health
Daniele Sartori, UMC
Dr David Health, University of Bangor
Dr Helen Macdonald, The BMJ
Florence van Hunsel, Netherlands Pharmacovigilance Centre Lareb
Georgia Richards, CEBM Oxford
Gerard Ross, UMC
Prof Jamie Coleman, University of Birmingham
Dr Jeffrey Aronson, CEBM Oxford
Prof Joan-Ramon Laporte, Autonomous University of Barcelona
Kath Sansom, Sling the Mesh (patient advocate)
Prof Emeritus Kay Dickersin, John Hopkins
Kim Witczak, consumer advocate
Dr Lars Jørgensen, Nordic Cochrane
Dr Marie Lindquist, UMC
Nicholas DeVito, CEBM/DataLab Oxford
Dr Peter Gøtzsche, Scientific Freedom Copenhagen
Dr Gilles Mignot, Prescrire International
Dr Ralph Edwards, UMC
Dr Rebecca Chandler, UMC
Prof Robin Ferner, University of Birmingham
Ruth Davis, CEBM Oxford
Dr Saad Shakir, Drug Safety Research Unit
Dr Su Golder, University of York
Dr Tianjing Li, John Hopkins
Dr Tom Jefferson, Cochrane Nordic & CEBM Oxford