Medical Information

Medical Information

Medical Information is a potential source for safety information and of importance for GVP compliance with the requirements for solicited adverse reaction reporting. Drug Safety Consult offers auditing and QA advice in the safety setup towards medical information and any E-Systems used.

How medical information is controlled, is a standard question during a pharmacovigilance inspection. Transparent and clear requirements towards all information relating to patient’ use of products is essential for a robust pharmacovigilance system, but control of this field also represents a challenge. Many companies need to rethink their processes and develop a blue print to ensure that relevant information is captured and processed according to regulatory expectations.

Contact DSC here.