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