Bringing a generic drug to market can be fraught with regulatory challenges and compliance issues. This course will allow the participants to gain a strategic insight into key requirements for developing generics from a global perspective and an overview of the generics market; current trends and practices; and future strategies for regulatory compliance.
Previously Vice President of Regulatory Affairs and Consulting Services at Catalent Pharma Solutions, Andrew is currently an independent regulatory affairs and pharmaceutical development consultant. Andrew has over 28 years of experience in regulatory affairs and pharmaceutical development, with specific experience of EU and US registrations, CMC regulatory requirements and multiple clinical aspects related to successful registration of drug products. Andrew is considered an expert in lifecycle management and has signifi cant experience in OTC and generic development, as well as global development strategies.
This course has been specifically designed to address the needs of: