Lacking "Mediator," EC Tightens Pharmacovigilance Proposals
This article was originally published in The Pink Sheet Daily
Executive Summary
European Commission's surprise update of the pharmacovigilance rules is included in its review of the information to patients legislation, but industry's biggest concern may be the failure to address the role of social media.
You may also be interested in...
EU SCOPE Project Will Harmonize Pharmacovigilance, Benefit Industry
The EU SCOPE pharmacovigilance project will harmonize practices across the 28 member states, thereby cutting the administrative and cost burden for pharmaceutical manufacturers.
Risk Management Professional Society Would Aim To Improve REMS Performance
Initial focus of volunteer industry group of pharmaceutical risk managers is drafting publications which assess the effectiveness of Risk Evaluation and Mitigation Strategies.
EMA Moves To Reassure Europe Over Combined Contraceptives
EMA says there is currently no cause for concern, amid increasing claims in Europe’s media that combined contraceptives can cause blood clots.