Cell & Gene Therapy Products – CMC & Quality Requirements

This unique course provides a practical & in-depth understanding of CMC & quality requirements and brings clarifications on global regulation, requirements, compliance &
quality concerns. Join us in Vienna and achieve CMC readiness for your cell & gene therapy medicinal products.

Stability & Shelf Life of Biologics

This 2-day course will provide practical insights into guidance & regulation for stability of biologics with focus on biotech products. Join this course & understand how to apply accelerated and stress stability assessment to predict your product stability.

Digital Quality in Clinical Trials

This unique course provides a practical & indepth understanding of the electronic systems and technologies used in clinical trials, and brings clarifications on global regulation, requirements, compliance & quality concerns.

Marketing Authorisation & Change Procedures for Generics

Understand the specific regulatory & legal environment concerning generic medicinal products. Update your knowledge on regulatory procedures for new applications and variations. Get an overview of the documentation for Generic applications. Understand the current integrated life-cycle approach from development to registration and maintenance, including ICH Q12.

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.

Retail Banking Forum

The Largest Retail Banking event in Europe.

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.