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 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
As in previous Fleming courses I joined: top
experts delivering the latest on their field in a very professional and accessible manner. Huge amount of information condensed in a well organized event. Great pleasure to attend and learn as much as possible.
Igor OruetxebarriaKuopio Center for Gene & Cell Therapy
Great training provided by knowledgeable experts. I learned a lot and will advice that training in my professional surrounding.
Fabrice HeitzFresenius Kabi SwissBiosim
Good and informative course with knowledgeable trainers.
Thanks for the great organization and the very informative presentation from Jörg and Robert. I really appreciated this training, the content, the case study and response to questions by trainers 😊 It was very helpful to better understand the regulatory requirements for biologics as I have just started to work in RA Biologics.