In late April, the Center for Business Intelligence (CBI) held a two-day forum on Drug Safety. The focus was REMS, the FDAs enforceable Risk Evaluation and Mitigation Strategy, and included discussions on REMS assessment, challenges, case studies, technology and more.
Applied Clinical Trials Editor Lisa Henderson attended the conference and blogged live. You can read the blogs by clicking the links below.
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Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.