W-05: QPPV, CO, and None: Which is Working and Which is Not Working?
Director, Pharmacovigilance, Clinical Development
Rockhill Consulting Japan
1. Understand what is the difference required for PV responsible person among three regions
2. Understand what is the issue for Pharmacovigilance (PV) responsible person as is at the current situation
3. Understand PROs and CONs in the perspective of industries and public health
Regulatory notice including Business Process Revision Order, Business operation Suspension Order were analyzed. Mass media dealing with the incidents were also analyzed.Regulation comparison in refer to PV responsible person were conducted using EU GVP Module, Japanese GVP and FDA Federal Register.
CO system in Japan was found most ineffective. QPPV system turned out not working when the authority of QPPV was not appreciated (by the company). No officially required responsible person (system) combined with company legal obligation looked going well judging from those incidents.
Many times CO system and QPPV system did not work in terms of regulatory compliance. Root cause analysis of the incidents reveal that CO and QPPV was looked as professional (perhaps medically) expert and did not own their authority in business management. CO (which requires pharmacist certificate) and QPPV (not strictly required but required to connect to medical professional) would be beneficial for regulatory inquiring level, is not the best organization for the pharmaceutical industries in terms of compliance.