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In-house Training Programme


Marketing Authorisations and Post-Approval Obligations in the EU

When What
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
GMP in-house Training Courses are an ideal solution for ten or more people and are very cost-effective. We come to you at a time and date to suit your organisation.

Please contact us if you are interested in a detailed offer.

The above agenda proposal has been developed for an in-house training course (group of participants). If you are interested to participate as an individual person please check our list of GMP training courses and conferences.


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