Addressing Post Authorisation Safety Study (PASS) under EU PV legislation and guidelines
Quintiles is a trusted partner in helping life sciences companies run post authorisation Safety study (PASS) that meet regulatory requirements. Our experts prepare you to meet global regulatory requirements with quality cost-effective approaches and to keep apace of global regulatory reporting requirements, including the European Union Pharmacovigilance Requirements.
A post-authorisation safety study (PASS) is conducted to identify, characterize or quantify a safety hazard; measure the effectiveness of risk management measures; or confirm the safety profile of an
authorised medicinal product.A PASS may be initiated, managed or financed by a Marketing Authorisation Holder (MAH) voluntarily or pursuant to an obligation imposed by a competent authority.
Leveraging dedicated safety, real-world and late phase resources
We offer a team of operational, strategic, scientific, legal, regulatory and quality experts focused on safety and real-world and late phase research, trained to meet global regulatory requirements with quality cost-effective approaches. Our experts have access to a proprietary Global Lifecycle Safety Regulatory Information Database (LSRID) that keeps apace of global regulatory reporting requirements, including the complex European regulatory landscape.