Summary of Current Requirements for Where to Send Adverse Event Reports.

Titel:
Summary of Current Requirements for Where to Send Adverse Event Reports.
Herkunft/Verlag:

GHTF

Inhalt:
Study Group 2 has made an attempt at producing unified guidance regarding who should adverse event reports must be sent to. The main alternatives discussed were: 1. Submission of reports to every regulatory authority of the countries where the device subject of the adverse event report is marketed; 2. Submission of a single report to the regulatory authority of the country in which the adverse event took place, and 3. Submission of a single report to a central global repository (database) of adverse event information.

Zurück

GMP Seminare nach Thema

Cookies helfen uns bei der Bereitstellung unserer Dienste. Durch die Nutzung unserer Dienste erklären Sie sich damit einverstanden, dass wir Cookies setzen. Weitere Informationen

OK