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Quality Requirements for Biotech Products

from First-In-Human to Phase III

  • 07/11/2018 - 09/11/2018
  • Frankfurt, Germany

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KEY TOPICS

Regulatory framework for Clinical trials of Biotech-IMPs

The quality challenges for Biotech-IMPs

GMP requirements for IMPs

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

Understand

  • 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

Learn

  • 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

Gain

  • 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

TRAINING FEATURES

Individual consultancy with the trainers

Interactive lecturing

All delegates receive comprehensive course documentation

Certificate of Completion issued by the Trainers

5h+ of Networking with other industry experts

Case studies from the trainer's experience

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