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Training Overview

The interface between Development and GMP units is one of the most exciting in the pharmaceutical industry. R&D needs flexibility and should not be over-regulated, whereas GMP concentrates on standardization and high throughput. On the other hand, R&D has to create a solid and robust fundament to enable manufacturing and quality control to work according to established and efficient procedures. The training aims to generate a common understanding of how to best interlink these two areas and create highly efficient processes from product development to routine manufacturing of generic pharmaceutical products.

Learning Outcomes:

  • Understand how Generics, Hybrid products, Biosimilars, and WEU products are defined in the EU legislation
  • How can the number of studies be limited by the application of the Biowaiver concept?
  • Overview of the different Marketing Authorisation procedures applicable in the EU and their use for Generics, Hybrid products, and Biosimilars
  • How should the manufacturing process be described in the CMC dossier compared to the GMP documents?
  • How to deal with more recent requirements concerning Elemental Impurities or N-Nitrosamines in CMC or GMP?

Who should attend?

  • Heads of R&D
  • Manufacturing Heads
  • Heads of QC
  • Heads of QA
  • Pharmaceutical Development managers
  • Manufacturing managers
  • Stability control managers
  • QC managers

Trainer

DR. HELMUT VIGENSCHOW
DR. HELMUT VIGENSCHOWSenior pharmaceutical consultant and founder of ViPharmaService

Download the Agenda

Download detailed Agenda - Development of generics: From R&D to GMP MasterClass