In an unregulated space, RWE/RWD studies are not governed by the compliance standard GCP. RWD studies can provide enriching evidence towards the efficacy and safety of marketed medicines and medical devices, however, standardization surrounding the design and execution of noninterventional clinical studies is yet to be identified.

Learning objectives:

1. Understand the expanded roles and responsibilities in the RWE setting
2. Leverage existing GCP principles and practices in the design of a compliant framework for RWE/RWD studies
3. Identify compliance risks and opportunities for QA/QC activities

Speaker:

Jan Pierre
Principal (GCP), Quality Compliance Solutions, IQVIA