CMC Analytical Comparability: Methods & Strategies for Biologics

TRAINING CMC Analytical Comparability: Methods & Strategies for Biologics 21- 22 October 2020 Vienna, Austria Day Hour Minute Second Analytical Comparability of Biologics, Biosimilars & Biobetters Comparability in Biologics Development The analytical strategies of protein characterization of Biologics & Biosimilars Online Live Training Features Virtual breakout rooms for workshop tasks & exercises Live discussions Chat … Continued

Quality Requirements for Biotech Products (From First-in-Human to Phase III)

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.

Bioanalytics for Biopharmaceuticals: Pharmacokinetics, Immunogenicity & Biomarkers

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.

Bioassays & Bioanalytical Methods Training

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.

Toxicology, ADME & Early Drug Development Plan

Building an Integrated Safety Testing Strategy based on ADME and Toxicology.

Electrostatic Precipitators (ESP) Maintenance & Operation Training

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.

Bioassays & Bioanalytical Methods

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.

CMC Analytical Comparability: Methods & Strategies for Biologics, Biosimilars & Biobetters

Learn more about Protein Characterization according to ICHQ6B at our CMC Analytical Comparability: Methods & Strategies for Biologics, Biosimilars & Biobetters by Fleming.