PRA Patient Safety and Pharmacovigilance Agreements
PRA Patient Safety and Pharmacovigilance Agreements
2 PagesSLIP SHEET PRA Patient Safety and Pharmacovigilance Agreements 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. PVAs define the pharmacovigilance activities that are required to meet both companies regulatory obligations in support of these products. 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. What is a Pharmacovigil
