CIOMS-WGIX-bonn2012CIOMS Working Group IX was created in April 2010 based on suggestions from a number of drug regulatory authorities and pharmaceutical companies. The overall objective of the efforts of this Working Group is to consolidate concepts of risk management tools and propose their application in order to harmonize views and globally protect public health, and to positively impact prescriber-patient interactions.

Risk management tools have evolved in an uncoordinated manner in different regulatory jurisdictions, and risk management systems with different concepts and sets of pharmacovigilance activities have been introduced. There are several tools that support the lifecycle process of biopharmaceutical product development, and a need has been defined for a harmonized risk management toolkit, providing outlines for content and usage of the toolkit, and describing the steps for its development and maintenance as the science of risk management evolves.

CIOMS Working Group IX is to develop a pragmatic consensus publication that would contain a harmonized list of tools for managing the risks of medicinal products intended for human use, as well as considerations governing the potential application of these tools. Consultation with stakeholders, including patient groups, has been promoted by members of the Working Group during the development of the CIOMS IX recommendations.

The Working Group will hold regular meetings over a period of three years, and it is envisioned that a report will be published in 2013.

New Meetings

1st Working Group on DILI Meeting, Geneva, Switzerland, 27-28 April 2017

11th Working Group on MedDRA IWG Meeting, Geneva, Switzerland, 22-23 March 2017

CIOMS 84th Executive Committee Meeting, Geneva, Switzerland, 28 November 2017

 

Recent Meetings

83rd CIOMS Executive Committee/General Assembly Meeting, Geneva, Switzerland, 29 November 2016

10th Working Group on MedDRA IWG Meeting, Geneva, Switzerland, 6-7 September 2016

10th Working Group Meeting on Revision of CIOMS International Ethical Guidelines, Utrecht, Netherlands, 1-3 June 2016

8th CIOMS Working Group Meeting on Vaccine Safety, Accra, Ghana, 22-23 March 2016

9th Working Group on MedDRA IWG Meeting, Geneva, Switzerland, 15-16 March 2016

82nd CIOMS Executive Committee Meeting, Geneva, Switzerland, 8 December 2015

ISoP meeting, Prague, Czech Republic, 27-30 October 2015

8th Working Group on MedDRA IWG Meeting, Geneva, Switzerland, 24-25 September 2015

7th CIOMS Working Group meeting on Vaccine Safety, near Philadelphia, PA, USA, 21-22 September 2015

8th Working Group X on Meta-analysis, New Brunswick, NJ, USA, 1-2 July 2015

9th Working Group on Revision of CIOMS International Ethical Guidelines, Paris, France, 14-16 June 2015

th Working Group on MedDRA IWG, Chavannes-de-Bogis, Switzerland, 19-20 May 2015

8th Working Group on Revision of CIOMS International Ethical Guidelines, Vilnius, Lithuania, 22-24 March 2015

6th Vaccine Safety Working Group, Lyon, France, 18-19 March 2015 

ISoP Meeting, Mysore, India, 12-14 January 2015

 

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