Solution for Pharmacovigilance - PhVExpert™

Every pharmaceutical company has to establish a pharmacovigilance system, with the primary aim of ENSURING TIMELY GATHERING, ANALYSING AND SUBMISSION OF SAFETY INFORMATION. This documentation is the primary target for any pharmacovigilance audit and thus has to be maintained in a way similar to GMP documentation.

PhVExpert™ fulfils the tasks of managing all of the events and documents in pharmacovigilance system.

PhvExpert™ is part of INFOTEHNA myPharmaExpert™ Suite developed specifically for Pharmacovigilance and addresses:

• Pharmacovigilance System Documentation
• Expedited Reporting of Individual Case Safety Reports
• Preparation and Electronic Submission of Individual Case Safety Reports (ICSR/eICSR)
• Periodic Safety Update Reports
• Automatic update with MedDRA
• Knowledge base