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.

Challenges of marketing authorisation and change procedures for generics in 2020

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.

How To Build A Compliance Program That’s Rightsized For Your Organization

Advanced IVIVC Professional

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.

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.

The Grey Zone, a practical guide to guide conduct, compliance and business ethics

Customer segmentation in healthcare engagement – Addressing the missing link

Optimal combination of toxicology and ADME in early drug development