David Nickerson, head of clinical quality management at EMD Serono, executive sponsor of TransCelerate’s ICH E6(R3) Initiative & PhRMA topic lead on the ICH E6(R3) Expert Working Group; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, and ACRO member participating in the ICH E6(R3) Initiative with TransCelerate, discuss:
- The newest ICH E6(R3) GCP guidelines
- Industry collaboration through TransCelerate and ACRO’s partnership
- Tools to help stakeholders better understand the latest GCP guidelines
- Their own recommendations for best practices in risk management and data governance
- and more!