Global Risk Management: Regulatory Harmonization Supports a Streamlined, Lifecycle Approach

Efforts to harmonize regulatory requirements are being welcomed as sponsors look to streamline their preparations for regulatory review. Recently, both the FDA and EMA issued updated guidance on risk management, influencing other regions as well. Soon after, the Council for International Organizations of Medical Sciences Working Group XII outlined its own approach to balancing product risks and benefits. Together, these recommendations support a consistent, global approach to managing risk. However, requirements for risk management planning and implementation still differ across regions.

This white paper reviews key elements of the latest guidance and explains how sponsors can streamline compliance, avoid duplication and build cohesion into risk management plans and submissions. It also explores how technology enables sponsors to manage additional risk management and mitigation programs and meet EMA requirements for measuring their reach and impact.