Do you need help to implement your Pharmacovigilance System? Develop Risk Minimization and Risk Management activities and plans? Prepare safety reports (DSURs, PSURs, PBERs)? Perform the Benefit Risk assessment? Prepare the safety part of your dossier for the submission of the Marketing Authorization Application or during the life cycle of your product?
Fouzia Guenaneche (MD, PhD), a senior Pharmacovigilance expert and a former regulatory assessor at the French Regulatory Agency, is an independent consultant who can help you to set up all these activities included in the SafeMedConsulting Services.
You need more explanations and details? Please contact Fouzia Guenaneche by mail or phone.