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
