Dan Feith of Orbit recently co-presented a webinar with Carla Perdun Barrett of PRA Health Sciences. The webinar recording is available here. The webinar abstract is described below.
Over the last decade, pharmacovigilance professionals have witnessed a significant shift in risk management activities with regard to updated guidelines and regulations beyond North America and Europe. Despite ICH E2E efforts to harmonize risk management requirements globally, variations in regulations and approach exist depending on the country or region.
To date, risk management regulations or guidelines are in place in over 70 countries around the globe. Additionally, health authorities without established risk management regulatory requirements or guidance may request risk management plans to review or require risk management activities be implemented. As the legislative landscape continues to evolve, the pharmaceutical industry has responded by developing flexible processes to meet the various scenarios and regulatory requirements in different countries. Oftentimes, a core or global risk management strategy is developed centrally and then provided to colleagues regionally for customization to meet local requirements. Mechanisms may be established to centralize or decentralize oversight of the local development of risk management plans, as well as local implementation of additional risk minimization measures or additional pharmacovigilance activities.
Companies must be able to demonstrate compliance with risk management commitments at any point in time. Furthermore, safety leaders are accountable for the performance of their risk management system. They must be able to review performance status on a regular basis and expect proactive resolution of any potential compliance issue. Tracking and monitoring of risk management commitments pose unique challenges due to the complexity of the activities, differences in healthcare systems and use of suboptimal and disparate tracking systems.
Flexible processes and systems are necessary to meet diverse regulatory requirements for risk management programs in various countries globally. In this free webinar, pragmatic approaches to implement and monitor risk management activities will be presented. Best practices and lessons learned will be shared by providing practical examples for day-to-day compliance monitoring as well as oversight of risk management requirements.