Search Results for MedDRA

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Updated: ICH Updates on MedDRA, New Members and Guidelines By Michael Mezher - Published 04 December 2017

The International Council for Harmonisation (ICH) on Thursday provided guidance and other updates, inaddition to news on developments for the Medical Dictionary for Regulatory Activities (MedDRA), following a recent meeting of the MedDRA management committee in Geneva, Switzerland.

Categories: News, ICH, Drugs, Postmarket surveillance

Tags: MedDRA, ICH, M1 Points to Consider

ICH Expands MedDRA's Uptake Globally By Michael Mezher - Published 12 June 2017

The International Council for Harmonization (ICH) on Monday touted the global expansion of its Medical Dictionary for Regulatory Activities (MedDRA) and provided updates on other activities related to MedDRA.

Categories: News, ICH

Tags: ICH, MedDRA, Medical Dictionary for Regulatory Activities

ICH Working Group to Provide More Detailed Guidance By Zachary Brennan - Published 23 January 2017

The International Council on Harmonisation (ICH) on Monday outlined a proposal to extend the remit of the Points to Consider (PtC) Working Group to provide more detailed guidance, examples and “Questions and Answers” on topics of regulatory importance such as data quality, medication errors and product quality issues.

Categories: News, Canada, Europe, US, ICH, Clinical, Crisis management, Drugs, Quality

Tags: MedDRA, pharmaceutical company guidance, medication errors

ICH Releases Updated MedDRA Guidance By Alexander Gaffney - Published 03 April 2012

Categories: ICH

Tags: Term Selection, Data Retrieval, Points to Consider Documents, MedDRA, Dictionary, Latest News, guidance