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The 6th 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 “Oriented to the Essence - Toward a New Era of Clinical Trials.”
In recent years, Patient-Centricity (PC) in drug development efforts, mainly in Europe and the US, have increased. While the concept of PC is very broad, essentially based on “Patient First” or “Patient Engaged,” regulators, academia, and pharmaceutical companies each seem to understand the PC concept differently. Efforts in this attempt to reflect the patient voice in drug development include on Clinical Outcome Assessment (COA), inputs to protocol design and Informed Consent documents, and feeding clinical trial results back to participating patients. PC was originally the essence of drug development. In this Workshop, we will work to understand old and new PC concepts. It is our opportunity to think about “What kind of change will PC bring about in future drug development?”
ICH - GCP (R2), covered in our previous Workshop, will be enforced in Japan. The purpose of GCP is to build drug development upon the two pillars of “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.” Its new revision adds “efficiency” as a new value and also introduces Quality Management System (QMS), and Risk-Based Monitoring (RBM) based on a “Risk-Based Approach.” This Workshop will feature keynote lectures on the two topics of PC and ICH - GCP (R2) under our “Oriented to the Essence - Toward a New Era of Clinical Trials” theme.
Regarding PC session, we will understand the concept and efforts of PC in academia and industry and discuss the future of PC-focused clinical trials. Similarly, we will learn about the latest ICH - GCP (R2) enforcement information in the keynote lecture, followed by discussion in the subsequent session of QMS as a key clinical trial component.
For protection of personal information, we offer a lecture to deepen your understanding of the revised Personal Information Protection Law established in May 2017, and also offer a session focused on the clinical trial site voice, which introduces efforts as a selected site in clinical trial, and we will argue the gaps between site and sponsor. In addition, the DIA Project Management Community session will explain useful and practical project management skills that facilitate effective clinical trials. We will also introduce the 2017 activities of the DIA Clinical Operation and Monitoring Community.
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.
Returning to the essence of our work, refining clinical operations, and using new values and methods to develop drugs, are required in new era. We believe that discussions in this 6th DIA Clinical Operations and Monitoring Workshop will lead to improvement of the clinical trial environment in Japan and, as a result, the realization of better medical care for all Japan’s patients.
Who should attend?
• Clinical research associate, site monitor
• Study manager, study leader
• Clinical development professional
• Clinical research coordinator
• Clinical data manager
• Clinical development related IT professional
• QC/QA professional
• Regulatory affairs professional
Keiichi Inaizumi, MSc • Manager, Clinical Operations and Compliance 1, Development Operations
Pfizer Japan Inc., Japan
Yukihiro Matsuda, MSc • Research Scientist, Trial Mgmt., Clinical Development Operations & Innovatiion
Eli Lilly Japan K.K., Japan
Norio Shimazaki • Senior Manager, CTA and STM Group, Regional Clinical Operation, Japan
Bristol-Myers Squibb K.K., Japan
Toshiya Hara • Executive Vice President
I'rom Co., Ltd., Japan
Toshiyuki Hata, PhD • Principal Inspector, Office of Non-clinical and Clinical Compliance
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Mitsuo Hayashi, MSc • Director, Clinical Enablement
MSD K.K., Japan
Toshiko Ishibashi, PhD, RN • Associate Clinical Operations Manager, Japan Site Management & Monitoring
AbbVie GK, Japan
Akiko Kitagawa • Consultant, Corporate Strategy Headquarters
EPS Corporation, Japan
Nobuhiro Koga, MBA, PMP • Portfolio Director, Portfolio Leadership
PAREXEL International Inc., Japan
Satoshi Saeki, MSc • Associate Director, Business Process Improvement & Innovation, QuILS
Astellas Pharma Global Development, Inc., United States
Eri Sekine • Department Head, Trial Monitoring, Japan Development, Global Development Ops.
Novartis Pharma K.K., Japan
Tsuyoshi Teramoto, PhD •
Hokkaido University Hospital, Japan
Miyoko Yamauchi •
Chugai Pharmaceutical Co., Ltd., Japan