LOG IN OR SIGN UP TO "MY Eu2P"JAPANESE REGULATIONS
OBJECTIVESThis course will bring you knowledge and understanding of Japanese pharmacovigilance regulations and guidelines. A comparison to EU and US legislation and practices is also provided. Emphasis is placed on the problems of interpretation of pharmacovigilance regulations both pre- and post-authorisation.
LEARNING OUTCOMESAt the end of this course, you will be able to understand and discuss the differences between US, European and Japanese Pharmacovigilance Regulations regarding both pre- and post-authorisation.
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AUTHORS
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Dr. Sherael Webley University of Hertfordshire |
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Edward Stewart Geary Chief Medical Officer, Senior Executive Director, Corporate Medical Affairs Headquarters, Global Safety Board Chair |
