Marketing Authorizations and Life Cycle Management

  Content Day 1
08.00 – 08.30 Welcome – Rationale of the Course
08.30 – 10.00 European Generic Market – Introduction and Current Overview
(Facts and data, developments)
10.00 – 10.30 Coffee break
10.30 – 12.00 Marketing Authorisation Applications – Registration Procedures within the European Union
(National procedure, MRP and DCP, CP)
12.00 – 13.00 Lunch break
13.00 – 14.30 Format and Content of the EU-CTD – An Overview
(Non-common part Module 1, common part Modules 2-5; QOS – Requirements and function)
14.30 – 15.00 Coffee break
15.00 – 16.30 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)
16.30 – 17.00 Q & A Session

 

  Content Day 2
08.30 - 10.00 EU-CTD Module 3 – Requirements for the Quality of Drug Substance and Drug Product
(Requirements for the Quality part for DS and DP)
10.00 – 10.30 Coffee break
10.30 – 12.00 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)
12.00 – 13.00 Lunch break
13.00 – 14.30 EU-CTD Module 5: Bioavailabilty/Bioequivalence – Special Topic for Generic Applications
(Requirements for BA/BE studies, common pitfalls)
14.30 - 16.00

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)

Draft ICH Q12 (Product Life Cycle Management)
16.00 - 16.45 Summarisation and Final Discussion
approx. 16.45 End of the Course

 

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