meet the training leaders
Robert E. Zoubek
Principal Consultant
Granzer Regulatory Consulting & Services, Germany
Dr. Jörg Engelbergs
Regulatory-Scientific Expert and Assessor
Paul-Ehrlich-Institute, PEI
All sessions of this unique course online
Live interaction options between the delegates and trainer
Available via mobile, tablet or laptop
Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!
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
Understand
• Regulatory landscape for national Clinical Trial Application (CTA) procedures
• How the assessors in Europe work
• Challenges for development of Biotech-Investigational Medicinal Products (IMP)
• Structure and content of the Quality IMP Dossier (IMPD)
• Design of comparability exercises after process changes
• Required stability data for phase I to III CTAs
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 Quality requirements from CTA phase I to III
• Stepwise requirements for process validation
• Characterization of physicochemical quality attributes
• Control of Drug Substance and IMPs
• Best practice: Presentation of the comparability data in the IMPD
• Quality related aspects of GMP inspections for IMPs
