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Draft additional list of EU HBD and DLPs, alphabetic order Authorization of medicinal products which could be administered to the pediatric population too. Electronic transmission of ICSRs in EU European Filling and Registration Procedure
Draft additional list of EU HBD and DLPs, alphabetic order The draft additional list contains harmonized birth date (HBD) and PSUR data lock point (DLPs) as proposed by MAHs. Most of the proposal concerns substances which are authorized in the EU before December 1976. However, also more recently authorized substances which are not included in the current list of HBDs and related DLPs for one reason or another are listed. The list has been compiled with input from representatives of EFPIA, AESGP and EGA.
Authorization of medicinal products which could be administered to the pediatric population too.
As of July 2008 marketing-authorisation applications for new product will have to include the results of studies conducted in the paediatric population in compliance with an agreed PIP http://www.emea.europa.eu/pdfs/human/paediatrics/leaflet.pdf
Electronic transmission of ICSRs in EU
Training performed by DIA – 27-29 August 2008- London http://evtraining.emea.europa.eu/ct/docs/e%20reporting%20of%20ICSRs.pdf
Medicinal product Dictionary
Training 16 September 2008- London http://evtraining.emea.europa.eu/ct/docs/EVMPD%202008_071107.pdf
European Filling and Registration Procedure
Training 16,17 October 2008, Dublin http://www.cfpie.com/showitem.aspx?productid=031
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