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All sessions of this unique course online

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Key Topics

Manufacturing of the Drug Substance and IMP

Requirements for process validation

IMPs comparators and placebos

Release specifications versus In-Process Controls, ICH guidelines

Analytical methods throughout clinical development, Batch data

The site master file (SMF)

Manufacturing process changes during clinical development

Key Takeaways


  • The principles of regulatory-scientific Quality assessment
  • EMA Guidelines and European Pharmacopeia Monographs
  • Manufacturing process development
  • Formulation development and choice of excipients
  • Batch record review and release methods


  • Stepwise requirements for process validation
  • Characterization of physicochemical quality attributes
  • Control of Drug Substance and IMPs
  • Best practice: Presentation of the comparability data for the IMPD
  • Quality related aspects of GMP inspections for IMPs


  • The regulatory landscape for national CTA procedures
  • How the assessors in Europe work
  • Voluntary Harmonized Procedure (VHP) in Europe
  • Quality challenges for Biotech-IMP development
  • Minimal required stability data for phase I to III


Online Live Stream

from 1596 € Buy


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