Bringing a drug product to market requires meeting variety of regulatory challenges and compliance issues. AAPS’s comprehensive course aims to clarify the global regulatory requirement as well as the impact of the latest regulatory changes to affect the pharmaceutical, biopharmaceutical and allied industries, focusing on the major strategic issues facing drug submissions. This course provides a clear understanding and in depth analysis of the Canadian, US, and European regulatory requirements. The course sections also examine the impact of the Common Technical Document.
This course is intended primarily for students wishing to pursue a career in the pharmaceutical industry, in Regulatory Affairs Departments.