Pharmacovigilance

With a provision of QPPV, Medical Advisor and other pharmacovigilance personnel services, CRO Biomapas overtakes all or part of Marketing Authorisation Holder’s obligations for the safety surveillance of their medicinal products:

• Adverse Drug Reaction management;
• MedDRA coding and medical assessment of safety information;
• Electronic reporting to EMEA and national competent authorities;
• Pharmacovigilance database;
• Global and local literature and databases screening;
• Compilation, review and submission of Periodic Safety Update Reports;
• Overall overview of medicinal product’s safety profile, risk-benefit balance assessment;
• Risk management;
• Legislative compliance and quality control.