TAGUNGSMAPPE
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Die Veranstaltung umfasst folgende Beiträge:
|
Nr. |
Thema |
Kurzf. |
Folien |
11072
| Marketing Authorisation Procedures in Europe | - | 55 |
11073
| Structure of the CTD: Modul 1 - National Requirements | - | 54 |
11074
| Structure of the CTD: Modul 2 - Quality Overall Summary - and Module 3 - Quality | - | 152 |
11075
| Structure of the CTD: Modul 4 and 5 - Clinical and non clinical documentation | - | 48 |
11076
| Certificate of Suitability (CEP) and Active Substance Master File (ASMF) | - | 45 |
11077
| Handling Variations and Changes during Marketing Authorisation Procedures | - | 56 |
11516
| The US Food and Drug Administration (FDA) - Structure and Tasks | - | 39 |
11517
| Getting Drugs Approved in the US | - | 71 |
11518
| Chemistry, Manufcturing and Control Quality Dossier in the US-General Information | - | 35 |
11519
| Chemistry, Manufacturing and Quality Control Quality Dossier in the US-Detailed Requirements | - | 45 |
11520
| Drug Master File Procedures in the US (US-DMF) | - | 23 |
11521
| Change Control and cGMP in USA | - | 49 |
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