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.
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.
This course will provide critical insights into various types of IVIVC and practical exercises focused on absorption determination, time scaling, prediction, determination of dissolution limits, case resolution problem from design of studies to utilization of IVIVC.
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.
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.