Pharmacovigilance Operations – Clinical trials

Case processing (SAEs)

The data generated from clinical trials tends to be more complete than that received through typical channels of spontaneous reporting. Likewise the steps for follow-up are often far easier to take. Nonetheless, you will need to demonstrate consistently that your reporting process is adequately specified and resourced to the task.

Clinical trial safety

Maintaining safety within clinical trials is of paramount importance to any pharmaceutical company wishing to bring new products to the market place or diversify their existing products.

SUSAR – Suspected Unexpected Serious Adverse Events Reporting

Electronic Reporting of Suspected Unexpected Serious Adverse Events (SUSARS) is now mandatory in many global territories.

Periodic reporting (DSURs)

Additionally to the need for expedited reporting of SUSARs, Development Safety Update Reports (DSURs) should be submitted to regulatory authorities and Ethics Committees throughout the clinical trial or on request. The DSUR takes into account all new available safety information received during the reporting period.

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