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What is a drug safety database?

What is a drug safety database?

Safety database is software that is used to store adverse event (AE), adverse drug reaction (ADR), serious adverse event (SAE), suspected serious adverse drug reaction (SUSAR) and pregnancy reports during clinical trials (CT) or when a pharmaceutical company has a marketing authorization (license) for a medicinal product.

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XEVMPD won’t be updated

XEVMPD won’t be updated

European Medicines Agency has confirmed that they will not update XEVMPD to support modern browsers. This means users have to continue accessing the product with browser extensions or other ways to emulate the dead and buried Internet Explorer.

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MLM Needs to Become Cost-Effective

MLM Needs to Become Cost-Effective

EMA will be spending over €30 million in the next 6 years or around €5 million per year on MLM and reporting ICSRs to EMA’s safety database, EudraVigilance (EV). Let’s have a look what those numbers actually suggest.

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What is the latest with DADI?

What is the latest with DADI?

We wanted to take a closer look into the latest updates on the project as there have been some last-minute changes to the scope of the first release and despite our trying our best, we were not accepted as testers in the first round of user acceptance testing (UAT) that is currently starting.

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