PHARMACOVIGILANCE PROCESSES EXECUTION FOR MEDICINAL PRODUCTS

Legislation requires marketing authorization holders to perform pharmacovigilance activities for their medicinal products.

We offer a full range of pharmacovigilance services for your products:

• Collection, analysis, and reporting of adverse reactions and other safety issues. Safety database management.
• Safety data exchange.
• Safety monitoring.
• Continuous benefit/risk assessment of your products.
• Development and maintenance of risk management systems. Implementation of risk minimization measures.
• Preparation and submission of periodic safety update reports to regulatory authorities.
• Signal management.
• Communication with regulatory authorities and the medical community regarding products' safety.
• Tracking the need to update information on the safety and efficacy of medical products.
• Training's system for MAH's staff on pharmacovigilance fundamentals and adverse reaction data collection methods.
• Participation in pharmacovigilance audits and inspections.