Regulatory Roundup: East African Community Joins ICH's Steering Committee
African Community Joins ICH's Steering Committee.
The East African Community (EAC) has joined the International Conference on Harmonization’s (ICH) steering committee as the sixth Regional Harmonization Initiative (RHI) member of the ICH Global Cooperation Group (GCG), according to an ICH press release. EAC represents the Republics of Kenya, Uganda, the United Republic of Tanzania, Republic of Rwanda and Republic of Burundi with its headquarters in Arusha, Tanzania. GCC currently includes APEC, ASEAN, EAC, GCC, PANDRH, and SADC, as well as Australia, Brazil, China, Chinese Taipei, India, the Republic of Korea, Russia and Singapore. GCC members participate in harmonization discussions but are not part of the original three harmonization regions: the United States, Europe, and Japan.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
