Marketing Authorisations and Post-Approval Obligations in the EU

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The agenda proposal aside 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.

Agenda Proposal

  Content Day 1
15.00 – 15.30 Welcome – Rationale of the Course
15.30 – 17.00 European Generic Market – Introduction and Current Overview
(Facts and data, developments)
17.00 – 17.30 Q & A Session
   
  Content Day 2
08.30 – 10.00 Marketing Authorisation Applications – Registration Procedures within the European Union
(National procedure, MRP and DCP, CP)
10.00 – 10.30 Coffee Break
10.30 – 12.00 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 Lunch Break
13.00 – 14.30 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 Coffee Break
15.00 – 16.30 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 Q & A Session

 

  Content Day 3
08.30 - 10.00 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 Coffee Break
10.30 – 12.00 EU-CTD Module 5: Bioavailabilty/Bioequivalence – Special Topic for Generic Applications
(Requirements for BA/BE studies, common pitfalls)
12.00 – 13.30 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 Summarisation and Final Discussion
approx. 14.15 End of the Course

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