EMA begins publishing all committee meeting agendas and minutes
This article was originally published in Scrip
The European Medicines Agency says it will in future publish the agendas and minutes for all of its seven scientific committees as a matter of course. The agency already publishes this information for four of its committees, and will now do the same for the remaining three – including the all-important human medicines evaluation committee, the CHMP.
You may also be interested in...
As companies undergo pharmacovigilance inspections from a growing multitude of regulatory authorities from around the globe, a senior pharmaceutical industry executive discusses how her company has been handling this complex and challenging task.
While inspection interviews can be stressful for drug firms, a Dutch pharmacovigilance inspector reassures companies that any responses made during the process cannot undo any good work they have already done. And they can also correct any wrong answers later on.
The Saudi Food & Drug Authority looks at the number of individual case safety reports (ICSRs) submitted by a company, among other risk-based factors, when drawing up its list for routine pharmacovigilance inspections.