The proactive planning of risk minimisation measures (RMMs) in the context of optimizing the benefit-risk profiles of medicinal product is a challenging task. RMMs should be commensurate to the risk in relation to the clinical benefit of the product and should work for the intended patient population without adding undue burden on the healthcare systems.

The recent updates to GVP XVI are likely to impact your current processes and procedures in strategy, implementation, and effectiveness evaluation of aRMMs. Are you and your organization ready? If you’re ready from a process standpoint, are you ready to evolve use of the toolkit provided within the revised guideline?

Join some of the top minds in risk minimisation as faculty and enjoy peer-to-peer interaction to discuss practical implementation and interpretation of Risk Minimisation Measures with this training course.

Walk away with immediately implementable ideas that will provide for better regulatory outcomes pre- and post-marketing!