DIA EUROPE 2020

The global regulatory landscape continues to evolve as regulatory authorities, sponsors and academics work together to advance and improve processes for evaluating aggregate safety data. Recent guidance indicate a shift in focus towards aggregate safety monitoring and scientific evaluation of integrated safety data earlier in the development program. This shift provides an opportunity for stakeholders to engage in the advancement of cross-disciplinary procedures for improving identification and characterisation of risks for a medicine on a program level. The FDA and EU regulators have strengthened requirements for aggregate analysis throughout development, especially regarding the reporting of SUSARs. In addition to existing regulations, regulators in both regions have issued additional guidance that lay out in greater detail expectations for a more systematic approach to identify and evaluate important safety information during clinical development. Despite some differences in thinking between the agencies, particularly in regard to expedited reporting of safety data from clinical trials, both agencies require sponsors to regularly conduct program-level reviews, considering data from completed and ongoing clinical trials.