Guides and Ebooks

Managing pharmacovigilance
in a ‘Compassionate Use’ context.

The value of getting Compassionate Use PV right.

The current rate of innovation in life sciences is unprecedented in recent times, and the high-profile progress of new drugs and treatments is generating great expectation and hope in the global market.

As important new products come through late-stage development, completing clinical trials, and edging closer to market authorisation, physicians and their seriously ill patients can request early access to medicines or therapies in return for important early real-world feedback about the products’ use beyond controlled trials.

This includes information about any Serious Adverse Events (SAE), which need to be monitored as closely as possible to ensure patient safety and proof of regulatory compliance. This important pre-authorisation activity will also feed into early marketing and commercial planning.

For drug sponsors and marketing authorisation applicants, managing these early access programmes can be a challenging task.

Arriello’s VP of Global Drug Safety Kieran O’Donnell has created a new guide that summarizes companies’ obligations for pharmacovigilance (PV) management and reporting in an unlicensed/compassionate use context, key variances in expectations between regulators globally, and proposes some practical next steps for companies looking to formalize and streamline their associated AE reporting.

Download full PDF to read more