Online Registration has been closed. Onsite Registration will be available at KFC Hall.

Program is Now Available! Click Here to View the Program.

The 4th DIA Clinical Operations and Monitoring Workshop is a prominent forum where industry, regulatory and academic professionals can gather for open discussion. This year, the forum focuses on “Clinical Operation Changes Clinical Trial.”

Discussion arising from “Risk Based Approach to Monitoring” demonstrates a growing need for change and improvement in operations and monitoring of clinical trials, while at the same time, ICH has made big changes in clinical development at the global level. E6 (R2), E9 (R1) and E17 are under discussion based on the current status of the global development and current clinical trial environment. Countries other than Japan, US and EU will have greater involvement in ICH activities, and further advancements in global development can be foreseen as a result of the increase in discussion and involvement from pertinent sectors.

What do we need to understand, what should we consider and what kind of action should we take in clinical operation and monitoring? With so many elements and restrictions intertwined, this question can be complicated. The path to clarification can be found through careful and efficient discussion.

In the workshop, participants will learn about the efforts done by SMO in Central Monitoring and/or Quality Management. We will analyze how the recent trend of global development and ICH discussion will impact clinical operations. Basic concepts of clinical trials will be reviewed to thoroughly understand the importance of clinical data and quality assurance. By recognizing the current clinical trial environment in Japan and incorporating various perspectives from clinical operations, we will discuss what contributions can be made to clinical trials and the medical environment.

As in past workshops, there will be Chatting Session for attendees to meet and exchange ideas.

Please note that the dress code is business casual to make the atmosphere of the workshop ideal for open discussion.