European Medicines Agency , London, UK
Sep 23 2011 8:00AM - 5:00PM
The European Medicines Agency (EMA) is organising this public awareness event to inform medicines regulatory authorities, pharmaceutical companies and IT vendors about the five new international Identification of Medicinal Product (IDMP) Standards and the intended implementation at ICH level (Topic M5). At the ISO TC 215 meeting in May 2011, the resolution was adopted that the Identification of Medicinal Products (IDMP) progresses to Final Draft International Standard (FDIS), a major step forward in finalising the five IDMP standards by beginning of 2012.
On Day 1, the 22 September 2011, experts from the EMA (European Medicines Agency), US FDA (Food and Drug Administration) and EDQM (European Directorate for the Quality of Medicines & Healthcare), who have been strongly involved in the standards development and in the drafting of the ICH Implementation Guide will provide participants with a detailed update on the latest version of the ISO IDMP standards and their implementation in the EU within the ICH framework. The use of the standards in the new ISO ICSR (corresponding to the ICH E2B (R3) topic) will be also addressed.
On Day 2, the 23 September 2011, the requirements, the timeframe and the process for the implementation of the new ISO IDMP standards in the context of the provisions laid down in Article 57(2), second subparagraph of Regulation (EC) No 726/2004 and the electronic submission of medicinal product information by marketing authorisation holders to the Agency will be addressed. Payment of registration fees must be received before commencement of the event.
Event Code: 11547
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