Post-marketing Pharmacovigilance

Post-marketing pharmacovigilance programs should not be handled applying a one-size-fits-all mentality. Requirements may look very different depending on the country or region in which a marketing authorization is held. The addition of business partners may create the need to write and maintain a safety data exchange agreement or a PV agreement. Changes to the safety profile of the product may require a more robust signal detection program to be implemented. A health authority may require a post-authorization safety study or a Risk Evaluation and Mitigation Strategy. Whichever way the life- cycle of your product takes you, ProPharma is here to support all of your needs. From our Benefit-Risk team to our QPPV office. Monitoring the safety of our client’s products, it’s what we do every day.