Pharmacovigilance Agreements (PVAs) are agreements between two companies based on their Commercial Agreements that require an exchange of safety information between the two companies. PVAs are not stand alone agreements but dependent on the relationships established between two companies regarding at least one medicinal and/or developmental product. The existence of strong PVAs is necessary to support the safety of the product and patient safety globally. PVAs may also be referred to as Safety Data Exchange Agreements by some pharmaceutical companies.
PV Nugget #6 Literature Surveillance
Literature is regarded as a significant source of information in the monitoring of a medicinal product, its safety profile, and benefit-risk balance.…
Pharmacovigilance & Patient Safety
Clinical trial participants help us speed breakthroughs in modern drug development. Our job is to protect them.
Aggregate Safety Reports
PRA Health Sciences (PRA) is dedicated to ensuring quality Aggregate Safety Reports are delivered to our sponsor and MAH partners. Our experienced…