2007/2008 have brought many changes in the field of regulatory affairs. 2009 casts its shadow ahead. - What kind of changes does the revision of the EU guidance on the SmPC bring? - What is the current status of the new variation regulation? - The paperless eCTD - is it a reality coming soon? - Sunset clause - are all questions answered?
Beside these topics all participants will get a thorough update on the work of the CHMP, the CMD(h) and the PDCO. - What are the capacities of the different authorities with regard to the decentralised procedure? - What kind of experiences could be gained in the CHMP within 4 years of EU enlargement? What are the current experiences with the PIP applications?
Don't miss this interesting meeting and use the opportunity to enter into discussions with the speakers.
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