Chaos to Clarity: Pragmatic Approaches to Overcome Challenges for Successful Implementation of Additional Risk Minimisation Measures in the European Union and the UK by a Marketing Authorisation Holder.

Background: Most national competent authorities issue guidance on the dissemination and implementation of additional risk minimisation measures (aRMMs), like the European Medicines Agency. However, national competent authorities guidance includes additional regulatory requirements, the reasons for which are unclear.

Objectives: The purpose of this study was to identify significant barriers to risk management implementation and methodological challenges encountered by local safety managers in the European Union and the UK owing to differences in country-specific regulations and regional national competent authorities guidance.

Increasing Efficiency and Cost-Effectiveness by Automating the Authoring of the Development Safety Update Report.

Introduction: A Development Safety Update Report (DSUR) is a comprehensive review of safety information collected during an annual reporting period for an investigational drug. The creation of a DSUR is a resource-intensive process, requiring effective communication among, and collaboration with, various functional stakeholders.

Objective: To increase the efficiency and cost-effectiveness of generating a DSUR with the use of an electronic authoring platform.