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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

Meet your prominent trainers

  • Dr. Jörg Engelbergs
  • Regulatory-scientific Expert
  • Paul-Ehrlich-Institut, Germany
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  • Dr. Robert E. Zoubek
  • Senior Consultant
  • Granzer Regulatory Consulting & Services, Germany
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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

Understand

  • 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

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 trainers

• Interactive lecturing

• All delegates receive a 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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