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Public Databases
Orphan Drugs
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Events:
„Projektmanagement in pharmazeutischer Forschung & Entwicklung“
Köln, 17./18. März 2016
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Der CMC-Manager in Regulatory Affairs
Köln, 2.12.2015 - 4.12.2015
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Authorisation
Notice to Applicants
Centralized Procedure (Notice to Applicants. Vol 2A, Chapter 4)
Presentation and Content of the Dossier (Notice to Applicants. Vol 2B)
EMA Presubmission Procedural Notes (Q&A): Innovative products
EMA Presubmission Procedural Notes (Q&A): Generic/hybrid applications