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Oracle Argus Interchange Japan Users Guide Release 8.1.3 F2108701July 2019Oracle Argus Interchange Japan User\'s Guide, Release 8.1.3 F2108701 Copyright 2019, Oracle and/or its affiliates. All rights
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Who needs oracle argus interchange japan?
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Oracle Argus Interchange Japan is typically needed by pharmaceutical companies, medical device manufacturers, or any organization involved in the management and reporting of adverse drug reactions and safety information in Japan.
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Medical regulatory authorities, healthcare professionals, and researchers may also benefit from using Oracle Argus Interchange Japan to exchange safety-related data and collaborate on pharmacovigilance activities.
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What is oracle argus interchange japan?
Oracle Argus Interchange Japan is a regulatory reporting system used for submitting adverse event reports to the Japanese authority, PMDA.
Who is required to file oracle argus interchange japan?
Marketing authorization holders (MAHs) or their representatives are required to file Oracle Argus Interchange Japan.
How to fill out oracle argus interchange japan?
Oracle Argus Interchange Japan can be filled out using the specified XML format and submission guidelines provided by PMDA.
What is the purpose of oracle argus interchange japan?
The purpose of Oracle Argus Interchange Japan is to ensure the timely reporting of adverse events related to pharmaceutical products in Japan.
What information must be reported on oracle argus interchange japan?
Information such as patient details, adverse event description, product information, and event outcome must be reported on Oracle Argus Interchange Japan.
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