Pharmacovigilance in Japan & China - An Interview with Edward Stewart Geary

Pharma IQ:  Can you outline the requirements for expedited and periodic reporting in Japan? Stewart Geary:  There are requirements for expedited reporting of individual case safety reports (ICSRs) both during clinical development and post-marketing as well as requirements for expedition of research reports and foreign action (measures taken overseas for safety) reports. All ICSR reporting in Japan is in an E2B-style electronic format. For periodic repo...
To continue reading this story get free access