Historically, the project began in 2003 as a CIOMS initiative, in response to indications received from some drug regulatory authorities and pharmaceutical companies that they had concerns about the parallel development of special drug safety search programs based on the Medical Dictionary for Regulatory Activities (MedDRA). This would cause an unavoidable duplication of effort and uncertainty within pharmaceutical companies about the utility of these searches on the part of drug regulatory authorities.
Read more: CIOMS Working Group on Standardised MedDRA Queries (SMQs)
CIOMS 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.
Read more: CIOMS Working Group IX on "Practical Considerations for Development and Application of a Toolkit...
Meta-analyses have been increasingly used in the scientific evaluation of efficacy and safety in benefit-risk assessments, as well as for pricing and the reimbursement of biopharmaceutical products. Over the last few years, the outcome of meta-analyses has been both debated and used as evidence within the regulatory process for human medicinal products, and their interpretation has ometimes contributed to different regulatory actions for the same product.
Read more: CIOMS Working Group X on "Considerations for applying good meta-analysis practices to clinical...
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11th Working Group on MedDRA IWG Meeting, Geneva, Switzerland, 22-23 March 2017
CIOMS 84th Executive Committee Meeting, Geneva, Switzerland, 28 November 2017
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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