What you need to know about access programs – Investigational Products Track Session Spotlight

by: Mark Corbett, Senior Vice President of Clinigen Global Access Programs Patients around the world are in urgent need of new therapies. Many have exhausted available treatment options and...
Continue Reading »

Scientific and Regulatory Considerations for Implementing Mathematical Models in the Quality by Design (QbD) Framework

by:Dora Kourti, PhD  The Role of Models in Quality by Design (QbD) was one of the topics chosen for Points to Consider by the International Conference for Harmonization (ICH),...
Continue Reading »