Articles tagged as 'regulation,regulation'

8 results

Stamping out drug adversity
The identification of medicinal products (IDMP) standards will help make sure patients get the right medicines and make it easier to detect problems when things go wrong.

Safety concerns with mesh implants – The regulator's voice
A regulator responds to the public outcry against patient harms suffered by women with surgical mesh implants.

Medical devices: urgent need for reform
Recent investigations into faulty medical device regulation have highlighted the need to broaden the scope of pharmacovigilance, to include more than just medications.

Pharmacovigilance takes centre stage with dedicated committee in CSDR
Pharmacovigilance has officially become one of the main initiatives of the CSDR with the creation of a dedicated committee, who held their first plenary meeting in April this year.

Safety concerns with mesh implants – The patient's voice
Following serious complications experienced by women with surgical mesh implants, patients and authorities alike believe tighter regulation on medical devices is needed.

VigiFlow eReporting for Industry increases the ‘flow’ of communication between industry and regulators
Since implementing this module into its safety reporting process, INVIMA has seen marked improvements in the quality, quantity, and timeliness of reports sent to VigiBase.

10 critical steps to improve patient safety worldwide
New 10-point plan urged to improve detection, analysis, and reporting of harms from medicines and devices to improve patient safety.

Interesting times indeed for Europe’s top medicines regulator
There was no chance the new head of the European Union’s medicines regulator could simply ease into the job. Emer Cooke, had Brexit and a pandemic on her desk from day one.

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