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 Pharma eReport Blog

Date: 1st May 2012, by: Nicky
Tags: EVMPD, XEVMPD, EMA, EudraVigilance

EMA to host IDMP Information Day in London on May 8th

The EMA will be hosting an Identification of Medicinal Products (IDMP) Information Day on May 8th 2012 in London.

The one-day course is aimed at preparing medicines regulatory authorities in the EU, IT vendors and pharmaceutical companies for the implementation of the new IDMP standards and adaptation of regulatory product management and pharmacovigilance systems.

By the end of 2012, final versions of the five new international Identification of
Medicinal Product (IDMP) standards and the ICH Implementation Guide (topic M5) are expected to have been agreed - meaning that pharmaceutical companies need to prepare now to put these new standards into operation, taking into account the timelines and requirements of new EU pharmacovigilance legislation and, in particular, in the context of Article 57 implementation.

The course programme will provide an update on the latest IDMP international standardisation activities and progress at the level of the ICH M5 EWG.  It will also examine the key principles of the ISO IDMP standards, with the main focus on medicinal product and substance identification (presented by representatives from the FDA and EMA).  Additional topics will include the identification of medicinal products from an industry perspective, and a Question and Answer session on Article 57 implementation.

For further information and to book your attendance, visit the event page: http://eudravigilance.ema.europa.eu/human/docs\8 May_12535_PGM.pdf

 

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