12th DIA Asia New Drug Conference in Japan

Labeling is the major “routine” risk minimization element in the risk management plan (RMP). This session provides updates on labeling and risk management in East Asia, in response to regulations that have been revised and/or newly issued in this region. The status of implementing RMPs, including patient information, in Korea, as well as labeling and labeling updates in China will be discussed. This session will also address one of the hottest topics across all regions, the status of electronic labeling. Panel discussion will address how ICH E17 will impact RMPs and labeling in this region.