Overview
Pharmacovigilance, or the activity of monitoring the safety of medicines in clinical use and taking appropriate action to minimise risk, is governed by a range of new EU legislation, a new Pharmacovigilance Risk Assessment Committee and guidance. The value that can be gained from adopting a benefit/risk management system not only addresses known and potential risks to support the current regulatory status of product but also will feed into the further development of a product as regard new indications and potentially moving from prescription only to over the counter.
This tutorial will discuss how access to robust evidence on emerging risk in post-authorisation phase, good data on how a medicine is used in clinical practice and data on background rates in the exposed population – gathering evidence throughout the product lifecycle will help move companies to a benefit/risk system. The ultimate challenge – is working towards an integrated regulatory system so you can query across all information within a company, designing safety studies, monitoring the effectiveness of the risk management systems and gather robust evidence from clinical practice.
The lessons learned and our experiences so far with post-authorisation commitments (e.g. BRMPs, PASS, PSURs) will be reviewed as will whether these commitments really do support an acceptable benefit/risk profile. This will include the novel approaches to managing benefit/risk to meet the needs of licensing medicines in biotechnology such as advanced therapies. Communicating benefit/risk will also be discussed as the new legislation will push for greater patient involvement within a benefit/risk system. Better methodologies and tools are required to support this integrated approach and adoption of a quality management system across global enterprise could achieve this.
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