Data Governance in ICH E6 (R3)

ICH GCP (E6 (R3)) has been revised. It contains important updates on data governance relevant to data managers and data scientists, e.g. on handling of computerised systems and the data processes throughout the data life cycle from data acquisition to data destruction, including for example data corrections, data cleaning and data finalisation. ICH E6 (R3) also contains new requirements on statistical programming, performed throughout the trial.

Join us for this session on data governance prior to the regulatory townhall to hear from a GCP inspector about the recent updates and its impact on data management.