| Day 1 |
|
| 15.00
– 15.30 h |
Welcome – Rationale of the Course |
| 15.30
– 17.00 h |
European Generic Market – Introduction and Current Overview
(Facts and data, developments) |
| 17.00
– 17.30 h |
Q & A Session |
| |
|
| Day 2 |
|
| 08.30
– 10.00 h |
Marketing Authorisation Applications – Registration Procedures
within the European Union
(National procedure, MRP and DCP,
CP) |
| 10.00
– 10.30 h |
Coffee Break |
| 10.30
– 12.00 h |
Format and Content of the EU-CTD – An Overview
(Non-common
part Module 1, common part Modules 2-5; QOS – Requirements and
function) |
|
12.00 – 13.00 h
|
Lunch Break |
|
13.00 – 14.30 h
|
EU-CTD Module 1 – Regional and Administrative Information –What has
to be considered?
(Administrative data, Module 1.2 Application Form and Annexes,
SPC, Packaging. Labelling and leaflet) |
|
14.30 – 15.00 h
|
Coffee Break
|
|
15.00 – 16.30 h
|
EU-CTD Module 3 – Requirements for the Quality of Drug Substance and
Drug Product
(Requirements for the Quality part for DS and DP) |
|
16.30 – 17.00 h |
Q & A Session
|
| |
|
|
Day 3
|
|
|
08.30 – 10.00 h
|
Quality of Drug Substance – Certificate of Suitability (CEP) and
Active Substance Master File Procedure
(Quality of DS via CEP or ASMF – Procedures, requirements, a
comparison) |
|
10.00 – 10.30 h
|
Coffee Break
|
|
10.30 – 12.00 h
|
EU-CTD Module 5: Bioavailabilty/Bioequivalence – Special Topic for
Generic Applications
(Requirements for BA/BE studies, common pitfalls) |
|
12.00 – 13.30 h
|
Post-approval Obligations and Handling Variations
(Post-approval obligations, e.g. pharmacovigilance; variations
regulations in the EU; IA/IB and type II variations, varitions vs
extension applications,)
|
|
13.30 – 14.15 h
|
Summarisation and Final Discussion
|
|
approx. 14.15 h
|
End of the Course |
