Opinion Split Over ICH Proposal To Limit Safety Data Collection
Some Feel ICH Guide Can Jeopardize Data Collection
A draft international guideline that proposes limiting safety data collection in premarket and postmarket trials if the drug’s safety profile is sufficiently characterized has drawn a varied response from a range of stakeholders in the EU.
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The International Council for Harmonisation is making big changes to its E19 guideline that proposes taking a targeted approach to safety data collection in some late-stage clinical trials. The draft guideline, which is largely similar to the US guideline on this topic, drew varied comments from stakeholders, including those from the EU.
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.