The IMPD is an mandatory part of the clinical trial processes and this ara involves heavy regulatory requiremens. This three day course will teach the participants necessary information for Quality requirements of Biotech-IMPs from non clinical use to Phase III clinical trials.
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This training will increase your understanding of what is needed to ensure good assay quality, what is the current view of the bioanalytical community and what regulators expect.
Three-day training focused on requirements and challenges in characterization of biotherapeutics using bioassays and bioanalytics. Biostatistics, bioassay validation and GCLP will be covered too.
Building an Integrated Safety Testing Strategy based on ADME and Toxicology.
The course will comprise basic understanding how and why an ESP collect dust, how different dust properties affect the operation, what to look after for maximum collecting efficiency, maintenance issues for efficient and long-time operation. There will be opportunities to bring up your own experience and problems.
Three-day training focused on requirements and challenges in characterization of biotherapeutics using bioassays and bioanalytics. Biostatistics, bioassay validation and GCLP will be covered too.
Learn more about Protein Characterization according to ICHQ6B at our CMC Analytical Comparability: Methods & Strategies for Biologics, Biosimilars & Biobetters by Fleming.