In order to promote the capacity of inspectorate, and improve the professional skills and comprehensive quality of the inspectors, CFDI held the third experts’ forum on April 26, 2019. Meisha Sampson, Assistant Country Director of US FDA China Office, was invited to give a lecture on “Pre-Approval Inspections (PAI)”.

Meisha Sampson introduced the overview of the US FDA PAI program and PAI Preparation, elaborated PAI objectives & techniques and shared PAI recommendations through the readiness for commercial manufacturing, conformance to application and data integrity. She answered the doubts about PAI. Attendees expanded the scope of knowledge and had a further understanding of PAI through the lecture and communication.

CFDI and 21 provincial drugs inspectorates from the whole country synchronously watching through video system participated in the training, totally more than 350 person participated in the training.