08.30 - 08.45 | Welcome |
08.45 - 09.45 | Phases in API and Drug Development |
09.45 – 10.45 | Clinial Trial Application and IMPD |
10.45 – 11.15 | Coffee Break |
11.15 – 12.15 | Marketing Authorisation Application and CTD |
12.15 – 13.15 | Lunch Break |
13.15 – 14.15 | Procedures for Marketing Authorisation Applications in the EU |
14.15 – 14.45 | Coffee Break |
14.45 – 15.45 | Quality Data in IMPD and CTD – What has to be provided? |
15.45 – 16.45 | How to deal with Changes/Variations |
16.45 – 17.00 | Final Discussion |
ca. 17.00 | End of Training Course |