Quality Officer Call for a New approach to Reduce Post Approval Complexity

An interesting call by Quality officers from 18 of the world’s largest 25 pharmaceutical companies agreed to reduce complexity of post-approval changes. The data in the publication reference changes can take from 6 months to 8 years.

Article Open Access: Approaches to Design an Efficient, Predictable Global Post-approval Change Management System that Facilitates Continual Improvement and Drug Product Availability | Therapeutic Innovation & Regulatory Science

Download PDF: https://link.springer.com/content/pdf/10.1007/s43441-024-00614-9.pdf