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Glossary

Periodic Summary Reporting

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Alternative reporting regime that is agreed between the manufacturer and the National Competent Authority for reporting similar incidents with the same device or device type in a consolidated way where the root cause is known or an FSCA has been implemented. 

Other glossary definitions

Q

Quality-by-Design(QbD)

Quality by design (QbD) is an approach that aims to ensure the quality of medicines…

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I

In Silico

Named after the silica, main component of computer parts. In silico technologies encompass a large…

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