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
Benefits of attending
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
Very complete and interesting.
Antonio TogniniCerbios Pharma
Great job, thanks for all the explanations and your
Anna CichelloCerbios Pharma
Trainers did a very good job answering all
our questions and did come up with different
examples for the explanations to make it more
understandable for all.
Interesting and useful content, clearly structured.