Session 8 Topic of Special Interest II: RWD/RWE for regulatory decision-making

Session 8-1 Teaching Materials

Session 8-2 Teaching Materials

Lecture 1:

The Challenges of the application of RWD/RWE in regulatory decision making from PMDA’s perspective - Atsushi Noguchi

In recent years, Real-world data (RWD) and real-world evidence (RWE) have been actively discussed in terms of utilization for regulatory decision making on efficacy and safety assessment of drug. In Japan, the Ministry of Health, Labour, and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) have worked to promote the utilization of RWD ranging from development through post-marketing surveillance of drugs and medical devices. In this session, I introduce the regulatory initiatives in Japan and PMDA’s efforts to promote utilization of RWD/RWE for regulatory decision making.

Lecture 2:

Evolving Role of Real-Word Data (RWD) & Evidence (RWE) in Drug Development - Alexander Liede