Marketing Authorizations and Life Cycle Management

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 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

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information