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The 5th DIA Clinical Operations and Monitoring Workshop presents a prominent forum where industry, regulatory and academic professionals can gather for open discussion. This year’s forum focuses on "Evolution and Challenges of Clinical Operations."

ICH E6 (Revision 2) is currently in the final stage of discussion. The intent of this revision is to introduce a systematic Quality Management system built upon the risk-based approach to clinical trials. There are many unanswered implementation questions, such as what kind of system is ideal and how much quality commitment is necessary.

But the revision of ICH E6 also presents good opportunity to review its essence – "protection of the human rights, maintenance of the safety, and improvement of the welfare of subjects participating in clinical trials" and "assurance of scientific quality of clinical trials and of reliability of results" – which is the objective of GCP. It is important that everyone involved in clinical trials return to the basics and provide ideas from each perspective (sponsors, industry, regulatory and academic professionals), with ownership and accountability, about which process should be improved and how, and how they will collaborate to improve clinical trial quality in Japan. National regulations such as the Ministerial Ordinance on Good Clinical Practice (GCP) will accordingly be revised. Now is the very best time for this first step leading to the improvement of the clinical trial environment in Japan.

In this workshop, leadership from the Office of Conformity Audit of the Pharmaceuticals and Medical Devices Agency (PMDA) will explain the revision of ICH E6, often called the core of clinical operations, and how it is reflected in the current state and future direction of national regulations. A member of the ICH working group will introduce future hot topics associated with clinical operations; the Quality Management System (QMS), which has a huge impact on the evolution of clinical operations; and examples of IT technologies used in the front lines. In another session, principal investigators and Clinical Research Coordinators (CRCs) will propose improvements to the clinical trial environment from their perspectives, while trial sites and sponsors discuss the gap revealed by the DIA Clinical Operations & Monitoring (COM) Community between the ideal and the real in clinical trials.

A large number of drug development stakeholders, such as CRAs and CRCs (i.e., frontline workers) are involved in clinical operations. While there has been much discussion of how these and related changes will fit into on-site operations, there have been few proposals for improvement. This workshop presents our chance to realize the passion of these frontline workers intending to improve the clinical trial environment.

The impact of natural disasters will be also be discussed, especially preparation for and response to earthquakes based on experience from of the 2016 Kumamoto earthquakes.

As in previous workshops, there will be a Chatting Session for attendees to meet and exchange ideas. Please note that the dress code is business casual to make the workshop atmosphere ideal for open discussion.