The Tenth Experts' Forum Was Successfully Held at CFDI in 2019
In order to promote the capacity of inspectorate, and improve the professional skills and comprehensive quality of the inspectors, CFDI held the tenth experts’ forum on November 6, 2019. Ph.D. Andrew Chang, Vice President of Quality and Regulatory Compliance of Novo Nordisk and a member of ICH Q12 EWG, Mr. Lars Guldbæk Karlsen, Senior consultant of quality department, Mr. Henrik Friese, Deputy President and Senior quality licensee of Novo Nordisk, was invited to give a lecture on “Lifecycle Management: ICH Q12”.
Ph.D. Andrew Chang explained in detail the background and content of the drafting of the ICH Q12 guiding principles, introduced the technical and regulatory considerations for ICH Q12 Pharmaceutical Product Lifecycle Management, and explained the ideal state that all parties should achieve in the quality management of pharmaceutical lifecycle. Mr. Lars and Mr. Henrik respectively introduced the specific practices of the quality management system and change control of manufacturing enterprise, and explained the practical experience of ICH Q12 lifecycle management. The explanations of the three experts gave the inspectors a deeper understanding of lifecycle management and provided useful experience and advice for regulators management innovation.
Office of Drug Registration of NMPA, Office of Drug Regulation of NMPA, CFDI, the Information Center, the Center of Beijing Drug Certification, the Center of Beijing Drug Evaluation and 20 provincial drugs inspectorates from the whole country synchronously watching through video system participated in the training, totally more than 240 person participated in the training