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11th Annual Meeting DIA Japan 2014

Nov 16 2014 9:00AM - Nov 18 2014 6:30PM | Tokyo Big Sight 3-11-1 Ariake Koto-ku Tokyo 135-0063 Japan

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Overview 

Online Registration has been closed.  Onsite Registration will be available at Tokyo Big Sight.

 

Recent DIA initiatives have improved cooperation between government, industry, and academia for the purpose of promoting the commercialization of innovative medical technologies and products in Japan, Europe, and the US. These entities, with the participation of patients, have also worked toward dramatically improving the development of new medical technologies, drugs, and medical devices. These movements share the goal of overcoming common boundaries in order to achieve meaningful medical innovations.

In Japan, two acts were enacted on November 20th, 2013 in order to bring world-class medical technology to the public. One new act, the “Act Concerning Safety Assurance of Regenerative Medicine, etc.,” centered on Regenerative Medicine. In addition, the revision of the Pharmaceutical Affairs Act introduced an Accelerated Drug Approval Program with conditions and time limits based on the characteristics of regenerative and other medicines.

Coupled with this framework of new regulations, breakthrough discoveries and inventions that originated in Japan, such as human induced pluripotent stem (iPS) cells and the medical robot suit, are expected to expand the horizons for health care of the future.

There are a wide variety of boundaries that we must transcend. These include the boundaries between industry, academia, government, and patients. There are also boundaries between specialized fields within science and technology; between pharmaceutical drugs, medical devices, and regenerative medicine; and between separate countries and regions. If the development of pharmaceutical drugs and medical devices only follows traditional methodologies and the assumptions of our current development environment, then it will become increasingly difficult to bring about revolutionary breakthroughs. It is essential that open innovation is encouraged in order to break down these existing barriers.

This year, our conference title calls on us to transcend these boundaries, and even surpass what we have taken as common sense or expected practice up until now with a strong will to make changes that can create a revolution in medical care.

Last year, the theme of the Japan Annual Meeting was “Revolutionary Drug Development.” This year, we would like to help you work across disciplines and areas of expertise to create medical innovation for the realization of a revolution in medical care that truly meets the needs of patients.

Hotel & Travel 

Attendees should make airline and hotel reservations as early as possible. To reserve your room at the Sun Route Hotel Ariake or the Washington Hotel Tokyo Bay Ariake being located close to the venue, please contact below:

Hotel Sun Route Ariake
Address:     3-6-6 Ariake, Koto-ku, Tokyo 135-0063
Telephone:  +81-3-5530-3610
URL:  http://www.sunroute.jp/ariake/

Washington Hotel Tokyo Bay Ariake
Address:     3-7-11 Ariake, Koto-ku, Tokyo 135-0063
Telephone:  +81-3-5564-0111
URL: http://tokyobay.washington-hotels.jp/

 

The most convenient airport is Haneda Airport and airport limousine bus services are available between the airport and the Tokyo Big Sight. For further information on the airport transportation, please visit the following link: http://www.limousinebus.co.jp/en/bus_services/haneda/odaiba_ariake.html

Contact Information 

Please contact the DIA Japan office in Tokyo for further information.

Tel: +81-3-5575-2130
Fax: +81-3-3583-1200
DIAJapan@diajapan.org
www.diajapan.org

Program Committee 

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Agenda  

Tutorials Sunday, Nov 16, 2014

  • 9:00AM - 10:30AM (Tokyo Standard Time)

    #1 Basic Introduction for Non-Specialist: Drug-Drug Interaction and Summary of Change in New Japanese Drug-Drug Interaction Guideline

    “Drug-drug interaction? It seems to be complicated, so let’s leave it to the specialists.” That may be current thinking, but will this attitude serve us in the future? New Japanese drug-drug interaction guidelines include drastic changes, such as the application of physiological-based pharmacokinetic (PBPK) models and concrete directions in the descriptions on package inserts. These changes will impact not only pharmacokinetic departments, but other segments of the industry as well, such as regulatory affairs, clinical development and postmarketing, and clinicians and pharmacists who use this information.

    This program will provide a basic understanding of drug-drug interaction and the background of new Japanese drug-drug interaction guidelines. The program will also explain the impact of these changes on package inserts. This information can help change “I don’t know” to “I understand!”

    Language:  Japanese language only

  • 9:00AM - 10:30AM (Tokyo Standard Time)

    #2 Next Steps for Content of Company Core Data Sheet Prepared by Western Companies - Part 1
    Since 2012, EU health authorities have issued a series of guidelines detailing their expectations on performance of pharmacovigilance for medicinal products in the European Union. This session will present those requirements affecting safety-labeling decision-making as part of the pharmacovigilance activities and explain, how the EU expectations will influence the design of the Global Labeling Process as well as the maintenance of Company Core Data Sheets in globally acting companies.
  • 9:00AM - 10:30AM (Tokyo Standard Time)

    #3 Action Learning for Six Sigma Analytical Tools Using Real Case Studies

    It’s very important to use appropriate tools when applying the Six Sigma process. In this program, we explain the methodology behind Six Sigma, DMAIC (Define-Measure-Analysis-Improve-Control). We will also introduce two analytic tools, Process mapping and Fish-bone diagrams, which are applicable in not only the Six Sigma project, but also in our day-to-day work activities.

    This session will be an interactive discussion using real case studies. Participants will learn how to apply these tools for process improvement.

    Language:  Japanese language only

  • 9:00AM - 10:30AM (Tokyo Standard Time)

    #4 Coaching as a Diverse Communication Tool Across Functions and Areas

    In the last DIA Japan annual meeting (2013), we shared the idea of using coaching tools as an effective communication process for driving projects.

    This session is designed as a workshop to learn theoretical concepts (coaching psychology and neuro-linguistic programming) as well as basic skills of coaching through roleplaying involving participants. Also, we would like to explore by means of dialog how we can make the most of these skills and tools in different situations of a project.

    1. Theoretical concepts of coaching
    2. Basic skills for active listening
    3. Basic skills for GROW model
    4. Dialog

    Language:  Japanese language only

  • 9:00AM - 10:30AM (Tokyo Standard Time)

    #5 The Basics of “Investigator Initiated Trial (IIT)” Regulation

    “Investigator Initiated Trial (IIT)” has an indispensable role of advancement of medicine, because IITs assume the role of awareness of treatment effectiveness, building evidences for standards therapies and developing new treatments for patients.

    IIT has gained name recognition since last year due to repeated media exposure. Unfortunately, the most media coverage was disturbing, and the public is rigorously questioning how an IIT should to be in Japan.

    Persons who engage in IIT are required to fully understand the international ethical guidelines and the related regulations in addition to high ethical standards when conducting a research. Currently, IIT is in revolutionary times: guidelines for ethical standards are under amendment. This tutorial session will provide an opportunity to learn the latest regulation, guidelines, and trends of IIT. Targeted audience includes physicians, nurses,pharmacists, and persons in pharmaceutical industry.

    Language:  Japanese language only

  • 11:00AM - 12:30PM (Tokyo Standard Time)

    #6 Prediction for Human Pharmacokinetics and Safety Using Systems Pharmacology

    This session will present the prediction of human pharmacokinetics and safety from in vitro data using the systems pharmacology approach.

    In addition, we will discuss IVIVE (in vitro to in vivo extrapolation) and physiologically-based pharmacokinetics (PBPK), and PBPK approach-based prediction for inter-individual variability regarding pharmacokinetic prediction. Furthermore, we will show the prediction for pediatric PK/PD using PBPK approach in order to optimize the pediatric dose.

    Conversely, we will focus on the safety issues regarding the prediction for QT interval prolongation. While hERG assay and clinical QT interval evaluation should be performed under the current guidelines, computer simulation and the PK/PD modeling approach for cardiac safety evaluation should become the main stream in the near future. In this program, we will present computer simulation to predict action potentials and human ECGs.

    Language:  Japanese language only

  • 11:00AM - 12:30PM (Tokyo Standard Time)

    #7 Next Steps for Content of Company Core Data Sheet Prepared by Western Companies - Part 2
    Company Core Data Sheets should be designed in a way that their content is suitable for implementation in national labeling in any country of the world. This session will explain important aspects of EU labeling requirements to be considered when creating Company Core Data Sheets in globally acting companies, to allow for adequate implementation in EU marketing authorisation applications or variations.
  • 11:00AM - 12:30PM (Tokyo Standard Time)

    #8 An Introduction to Adaptive Designs

    This tutorial will cover an introduction to adaptive designs. The choice of design, adaptive or fixed, depends on many factors (such as uncertainty of compound attributes) and needs to be considered within the context of the entire clinical plan. Expected audiences are both statisticians and non-statisticians who are involved in study planning and execution.

    Bayesian and Frequentist methodologies which can be used to perform adaptations in a trial will be described and how they can be used in adaptive designs will be illustrated. Trial simulations are useful and often necessary to understand the operating characteristics of a design. Real examples of simulations will be provided.

    Case studies of several types of adaptive designs will be provided including sample size re-estimation, adaptive treatment allocation, group sequential designs, and seamless designs. Regulatory as well as implementation challenges of adaptive designs will be
    discussed. Brief summaries in Japanese will be provided between parts.

    Language:  English language only

  • 11:00AM - 12:30PM (Tokyo Standard Time)

    #9 Let’s Learn and Talk about Project Management Basics of the Clinical Study in Medical Institutes!

    In this program, we will introduce the PM basic framework using an Investigator Initiated Trial (IIT) case study. During the group work session, we will discuss schedule planning and explain other PM tools.

    We hope this training will provide information on how to resolve issues, as well as some of the day-to-day challenges involved with PM. The training will also help improve your IIT process effectively and efficiently by utilizing PM tools, plus provide an opportunity to build and strengthen the network among participants who have similar interests and challenges.

    Language:  Japanese language only

  • 11:00AM - 12:30PM (Tokyo Standard Time)

    #10 HTA 2016? What are the challenges for Japan?

    The debate on HTA continues in Japan, with a focus on trying to understand the methodology and how it could apply to the healthcare system in this country. At the same time in Europe, the field of HTA is in rapid evolution — due to refinements to the methodology of HTA itself, but also because of the request for convergence between requirements from regulatory and HTA agencies for additional data. The session will briefly cover the basics of HTA, and its implications for Japan.

    Language:  Japanese language only

Day 1 Sunday, Nov 16, 2014

  • 9:20AM - 12:30PM (Tokyo Standard Time)

    Student Session


    Session Chair(s):

    • Mitsuo Ishikawa
      Graduate Student
      Keio University Graduate School of Pharmaceutical Science, Japan
    • Hotaka Maruyama
      Graduate Student
      Keio University Graduate School of Pharmaceutical Schience, Japan
    • Ayako Ono
      Graduate Student
      Chiba University , Japan
    • Daichi Yaguchi
      Graduate Student
      Musashino University, Japan

    Speaker(s):

    • Discussion on Drug Information: How It Is and How It Should Be Communicated with Patients
      Osamu Komiyama
      Senior Manager, Statistical Research & Consulting Group, Clinical Statistics
      Pfizer Japan Inc., Japan
    • Discussion on Drug Information: How It Is and How It Should Be Communicated with Patients
      Yoichi Ishikawa
      Director, Department of Pharmacy
      National Center for Child Health & Development, Japan
    • Discussion on Drug Information: How It Is and How It Should Be Communicated with Patients
      Kazushige Murayama, PhD
      Lecturer, Faculty of Pharmacy
      Musashino University, Japan
    • Jun Urushidani
      Student
      Keio University, Japan
  • 1:30PM - 2:05PM (Tokyo Standard Time)

    Welcome, Opening Remarks, Global DIA Awards Presentation, and Program Instructions

    Speaker(s):

    • Ko Sekiguchi, MBA
      Representative Director
      DIA Japan, Japan
    • Barbara Lopez Kunz
      Global Chief Executive
      DIA, United States
    • Tatsuo Kurokawa, PhD
      Professor, Div. of Drug Development and Regulatory Sciences, Faculty of Pharmacy
      Keio University, Japan
  • 2:20PM - 3:10PM (Tokyo Standard Time)

    Keynote Speech 1


    Session Chair(s):

    • No-image Kazuhiko Mori, MSc
      Director, Evaluation & Licencing Div, Pharmaceutical & Food Safety Bureau
      Ministry of Health, Labour and Welfare, Japan

    Keynote speech 1 of 2014 DIA Japan Annual Meeting will be presented by Dr. Hiroo Imura, President of Foundation for Biomedical Research and Innovation (FBRI). Dr. Imura successively held number of important positions such as President of University of Kyoto, Member of Council for Science, Technology and Innovation and since 2014 as President of FBRI has been leading the largest medical cluster in Japan promoting practical application of advanced medical science such as regenerative medicine. Further as Chairman of General Assembly of The Japan Association of Medical Science 2015 Kansai, Dr. Imura is challenging to new initiatives which will enhance innovation in medical science and medical treatment to be participated by all stakeholders including various professional fields, generations and patients and families. It is a great opportunity that we can listen to Dr. Imura’s future vision who is really leading various significant initiatives in medical society now which transcend boundaries.

    Speaker(s):

    • Hiroo Imura, MD, PhD
      President
      Foundation for Biomedical Research and Innovation, Japan
  • 3:10PM - 4:00PM (Tokyo Standard Time)

    Keynote Speech 2


    Session Chair(s):

    • No-image Junichi Nishino, MSc, RPh
      Head, Regulatory Operation & Prescribing Information Group, Drug RA Dept.
      Novartis Pharma K.K., Japan

    Speaker(s):

    • Satoshi Furukawa, MD, PhD
      Astronaut
      Japan Aerospace Exploration Agency (JAXA), Japan
  • 4:30PM - 5:45PM (Tokyo Standard Time)

    Special Session: Opening Plenary


    Session Chair(s):

    • No-image Tatsuo Kurokawa, PhD
      Professor, Div. of Drug Development and Regulatory Sciences, Faculty of Pharmacy
      Keio University, Japan

    Speaker(s):

    • Future visions for international regulatory collaboration: Australian perspective
      John Skerritt, PhD
      National Manager
      Therapeutic Goods Administration (TGA), Australia
    • Tatsuya Kondo, MD, PhD
      Chief Executive
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Day 2 Monday, Nov 17, 2014

  • 9:00AM - 10:30AM (Tokyo Standard Time)

    [V1-S1] Vision for the Future: Global Simultaneous Filing to the World First Approval - Strategies for Early NDA Approval


    Session Chair(s):

    • Satomi Ando, MSc
      Head, Medical Writing & Communication Dept, Development Div.
      Novartis Pharma K.K., Japan

    Speaker(s):

    • An Experience of the First Submission in JapanAhead of Other Regions: A Case of Global NDA Filing for 2 Indications in 1 Submission
      Tomohiko Kumakura, MSc
      Senior Director
      Daiichi Sankyo Co., Ltd., Japan
    • Opportunities and Challenges in the Preparation of a World-First Japan Filing in a Global Development Project
      Yuka Wakimura
      Associate Director, Asia-Pacific, Global Regulatory Affairs
      Janssen Pharmaceutical K.K., Japan
  • 9:00AM - 10:30AM (Tokyo Standard Time)

    Listen to What the Patient Has to Say-A Message from Patients to Those Engaged in Drug Development -


    Session Chair(s):

    • No-image Kazumichi Kobayashi, RPh
      Senior Research Fellow, Office of Pharmaceutical Industry Research
      Japan Pharmaceutical Manufacturers Association (JPMA), Japan

    Listen to What the Patient Has to Say-A Message from Patients to Those Engaged in Drug Development -

    Speaker(s):

    • Tateo Ito
      President
      Japan Patients Association, Japan
  • 9:00AM - 10:30AM (Tokyo Standard Time)

    [V3-S1] The Dawn of Advanced Regulatory Review and Consultation


    Session Chair(s):

    • No-image Motohide Nishi
      Director, Asia Pacific Data Sciences & Solutions, Medicines & Development Unit
      Eli Lilly Japan K.K., Japan

    Speaker(s):

    • Future Plans for Advanced Review with Electronic Data in Japan
      Mayumi Shikano, PhD
      Director, Office of Standards and Guidelines Development
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • From FDA's Perspective
      Ron Fitzmartin, PhD, MBA
      Senior Advisor, Data Standards Program, Office of Strategic Programs, CDER
      FDA, United States
    • The Dawn of Advanced Regulatory Review and Consultation-From Industry’s Perspective -
      Hironobu Saito, PhD
      VP, New Drug Regulatory Affairs Dept.
      Daiichi Sankyo Co., Ltd., Japan
    • CDISC Global Data Standards
      Bron Witt Kisler
      Vice President, Strategic Alliances
      CDISC, United States
  • 9:00AM - 10:30AM (Tokyo Standard Time)

    [V4-S1] Points to Consider on the Biosimilar Development - Comparability Evaluation, Interchangeability, Advantage of Biosimilar Development


    Session Chair(s):

    • Teruyo Arato, PhD
      Professor, Department of Regulatory Science
      Hokkaido University Graduate School of Medicine, Japan

    This program will cover the current state and challenges of using biosimilar products from development to approval, as well as their usage in hospitals. Topics will be covered from the viewpoints of industry, government, and academia. Now that the first biosimilar antibody has been approved in Japan, the challenges for biological products that have complicated structure and interchangeability will also be discussed. In addition, the switch from innovator drugs to biosimilar drugs at medical institutions will be discussed, as well.

    Speaker(s):

    • Biosimilar Medical Needs and Development in Japan -Experiences and Challenges-
      Yoshihiro Nambu, MD, PhD
      Chief Medical & Scientific Officer, Head of Pharmaceutical Development
      Nippon Kayaku Co., Ltd., Japan
    • Quality of Biosimilar Product - From a Viewpoint of CMC
      Katsuya Nishino
      Representative Director, Executive Vice President
      JCR Pharmaceuticals Co., Ltd., Japan
    • Considerations on extrapolation of indications
      Reiko Yanagihara, PhD
      Principal Reviewer, Office of Cellular and Tissue-based Products
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • How to Decide the Interchangeability from Innovator Drugs to Biosimilars: Why Can You Switch Or Not?
      Susumu Yokoya, MD, PhD
      Vice-Director
      National Center for Child Health and Development, Japan
  • 9:00AM - 10:30AM (Tokyo Standard Time)

    [V5-S1] Leading Innovation with Stakeholders — the Project Meeting Management


    Session Chair(s):

    • Kouji Iwasaki, PhD
      Director, Global Medical Affairs, Japan Department
      Takeda Pharmaceutical Company Limited, Japan

    It is important to manage communication in cross-functional projects to produce innovation with stakeholders. One important communication management tools are meetings. Meetings are not only for progress reports, but for process management from project initiation to closing. The capability to manage meetings helps achieve project goals. In this session, members will learn the basics of meeting managements and the process design of project meetings, and discuss their applications in real-life settings.

    Speaker(s):

    • Shuji Sumida, MPharm
      Department Manager, Quality & Regulatory Compliance Dept.
      Chugai Pharmaceutical Co., Ltd., Japan
    • Koichi Konno
      PM Consulting Positive Intention, Japan
    • Kouji Iwasaki, PhD
      Director, Global Medical Affairs, Japan Department
      Takeda Pharmaceutical Company Limited, Japan
  • 9:00AM - 10:30AM (Tokyo Standard Time)

    [V6-S1] Made in Academia: Seed Development Initiatives


    Session Chair(s):

    • No-image Hideki Hanaoka
      Director of Clinical Research Center
      Chiba University Hospital, Japan

    In Japan, there are 15 core clinical research centers receiving strong support from the government. Their academic expertise is integral to the field of seed development. Overcoming obstacles to transfer the results of basic research into clinical research is not easy for academia, and collaboration with pharmaceutical companies and regulatory agencies is indispensable. Furthermore, there are expectations for the development of a Japanese NIH and national strategy districts. In this session, we will focus on several examples of successful seed development in medical institutions. In addition, we will examine the issues, direction, and solutions of the possibilities and outputs of drug development from the strategic viewpoint on pharmaceutical affairs of regulatory agencies.

    Speaker(s):

    • Drug Discovery: Role and Significance of Academia
      Toshio Miyata, MD, PhD
      Associate Executive Vice President
      Tohoku University, Japan
    • Identification and Modification of Novel Anti-Microbial Peptide toward Topical Wound-Healing Drug
      Hironori Nakagami, MD, PhD
      Professor, United Graduate School of Child Development
      Osaka University, Japan
    • A Clinical Trial for POEMS syndrome
      Sonoko Misawa, MD, PhD
      Assistant Professor, Department of Neurology
      Chiba University, Japan
  • 11:00AM - 12:30PM (Tokyo Standard Time)

    [V1-S2] Vision for the Future: Global Simultaneous Approval — Efforts and Challenge for Simultaneous Review on Each Country


    Session Chair(s):

    • Fumiaki Kobayashi, PhD
      CEO
      CTD Inc., Japan

    In this session, we will focus on the process of submission to approvals in the review period, as well as global simultaneous submission and its challenges. The main topics include the issue of submission timing of answer as the analysis of trends in questionnaires in each authority (PMDA/FDA/EMA). (NOTE– I don’t know what this means.) During the panel discussion, we will discuss the issues between PMDA and companies regarding the challenges of simultaneous review, and the differences of each authority.

    Speaker(s):

    • Comparison of the queries during a simultaneous review by PMDA/FDA/CHMP
      Kazumi Sunamura
      Director, Regulatory Strategy & Policy 2
      Pfizer Japan Inc., Japan
    • Experience of Global Simultaneous Submission and Challenges
      Chitose Nishida
      Manager, Regulatory Excellence Dept
      GlaxoSmithKline K.K., Japan
    • Considering Point and Future Networking with Foreign Regulatory Authorities in Global Simultaneous Review
      Toyotaka Iguchi, MD, PhD
      Review Director, Office of New Drug V
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • 11:00AM - 12:30PM (Tokyo Standard Time)

    [V2-S2] Discussion About the Provision of Information for Patients —What is a Patient- Oriented Information from the Regulatory Agencies, Pharmaceutical Companies, and Medical Professionals?


    Session Chair(s):

    • Mayumi Mochizuki, PhD
      Professor, Evaluation & Analysis of Drug Information
      Keio University Faculty of Pharmacy, Japan

    In Europe, pharmaceutical companies are obligated to prepare Patient Leaflets. Patient Leaflets are written in a simple language to help patients understand the content. Patients can thus obtain information, designed specifically for patients, about any medications prescribed. In Japan, the Patient Medication Guide or Drug Information Sheet is prepared for some drugs; however, patients and their families still have difficulty in obtaining or understanding appropriate information about diseases or drugs. Pharmaceutical companies have not well understood the current situation in Japan. In this session, the regulatory agencies, pharmaceutical companies, and medical professionals will present their view on the current state, and what future actions are needed, including their request regarding the provision of information for patients. In addition, they will share and discuss with attendees topics related to information for patients.

    Speaker(s):

    • Discussion About the Provision of Information for Patients —What is a Patient-Oriented Information from the Regulatory Agencies?
      Shinobu Uzu
      Director, Safety Div, Pharmaceutical and Food Safety Bureau
      Ministry of Health, Labour and Welfare, Japan
    • What Makes a Good Drug Information Leafletfor Patients
      Michiko Yamamoto, PhD
      Professor
      Showa Pharmaceutical University, Japan
    • TBC
      Masami Kojima
      The Mainichi Newpapers Co., Ltd., Japan
    • Provision of Drug Information to Patients from Pharmaceutical Company
      Chiyomi Takahashi
      Japan Pharmaceutical Information Center, Japan
    • Takako Yamazaki
      CANCER RIBBONZ, Japan
  • 11:00AM - 12:30PM (Tokyo Standard Time)

    [V3-S2] Medical Big Data Usage — Hopes and Challenges in Clinical Development and Postmarketing Safety Surveillance


    Session Chair(s):

    • Tomiaki Morikawa, PhD, MBA
      Associate Professor
      Keio University Graduate School of Media and Governance, Japan

    Big data have recently brought global attention to various industries in many different ways. One could say; that Japan has fallen far behind in the practical usage of big data compared to the rest of the world. Japan is now starting to revise the policies that regulate personal data usage. Given the significant attrition rates in research and development (R&D), to plan and conduct appropriate clinical trials based on scientific grounds is becoming more and more crucial. In addition, optimization of post marketing safety measures using drug usage data of the real world clinical setting is desirable. This session introduces a few examples of big data usage overseas and discusses Japan’s current situation and challenges.

    Speaker(s):

    • US Cases of Medical Data Usage
      Benjamin Gross, PhD
      Accenture LLP, United States
    • Applying Big Data for Pharmaceutical Research
      Rami Suzuki, PhD
      President, Senior Group Officer, Global Business Development Unit, ECL
      Eisai Co., Ltd., Japan
    • Leveraging Big Data to Drive Appropriate Usage of Medicinal Products
      Hiroshi Tamada, MD, PhD, MBA
      Executive Officer, Vice President, Japan Medical Affairs & Pharmacovigilance
      Bristol-Myers K.K., Japan
    • A Case of Medicinal Data Usage in a Clinic
      Yasuhiko Munakata, MD, PhD
      CEO
      Munakata Yasuhiko Clinic, Japan
  • 11:00AM - 12:30PM (Tokyo Standard Time)

    [V5-S2] Magic Bullets for conflicts!! – Case Study of Conflict Prevention and Resolution in R&D Projects


    Session Chair(s):

    • Michiyo Tani, MBA, RPh
      Manager
      Foresight Group Japan, Japan
    • No-image Atsushi Tsukamoto, PhD, MSc, PMP
      Senior Director, Global Project Management
      Daiichi Sankyo Co., Ltd., Japan

    In pharmaceutical R&D projects, there are conflicts caused by different positions of responsibilities, which happen frequently. Unnecessary conflict should be avoided. However conflict itself can be a trigger of breakthrough and the opportunity to build team’s functionality stronger. In this session, we would like to introduce methodology and tools of project management, Six Sigma and facilitation to prevent and resolve the conflicts, through a case study of an R&D project. We hope that those clues are useful for your business from now.

    Speaker(s):

    • Proactively Addressing Conflicts - Learings from a Facilitation Methodology
      Akira Kato
      Manager, Research & Consulting Division, Society & Industry Design
      The Japan Research Institute, Japan
    • To Lead the Healthier Resolution of Conflictwith Six Sigma Tools-Such an Useful Way in Conflict Management-
      Yusuke Tsutsumi, PhD
      Assistant Manager, Global Management Group
      Mitsubishi Tanabe Pharma Corporation, Japan
    • Let’s prevent unnecessary conflict by using project management tools!
      Yasuo Fukushima
      Manager
      Daiichi Sankyo Co., Ltd., Japan
  • 11:00AM - 12:30PM (Tokyo Standard Time)

    [V4-S2] Bridging the Gap between Bio-ventures and the Pharmaceutical Industry to Form Drug-Making Partnerships


    Session Chair(s):

    • Satoshi Toyoshima, PhD
      Professor, Faculty of Pharmacy, Graduate School of Pharmaceutical Sciences
      Musashino University, Japan
    • No-image Kazumichi Kobayashi, RPh
      Senior Research Fellow, Office of Pharmaceutical Industry Research
      Japan Pharmaceutical Manufacturers Association (JPMA), Japan

    The Faculty of Pharmacy, Musashino University, and the Office of Pharmaceutical Industry Research (OPIR) have performed investigations and gap-analysis surveys between bio-ventures and pharmaceutical companies. First, three speakers will present their own experiences and thoughts from the point of view of investor, advisor, and portfolio manager of a pharmaceutical company. In addition, a researcher from Musashino University will briefly present the outcome of the survey. All members, including session chairs, will take part in a panel discussion to discuss topics such as “What is the bottleneck to be a partner”, “How to find a clue to a solution”, “What is the best approach for the future collaboration”.

    Speaker(s):

    • Challenges in Building of the Ecosystem of Drug Discovery and Development
      Koichi Ashida
      Managing Director
      Innovation Network Corporation of Japan, Japan
    • Who are Clients for Bio-Ventures?Impact of Changing Market Environment of Healthcare and Pharmaceutical on Growth on Bio-Venture
      Tetsushi Inada, PhD
      President & Managing Director
      Pharma-East Insight, Inc., United States
    • Harness Innovation in Japan for Global Drug R&D: Opportunities, Challenges and Pfizer Approach
      Shinji Ogawa, PhD
      Senior Manager, Japan Portfolio & Project Management
      Pfizer Japan Inc., Japan
    • Analysis of Perception Gap on Alliance Activities between Japanese Biotechnology Venture Companies and Pharmaceutical Companies
      Masafumi Shimokawa
      Faculty of Pharmacy, Graduate School of Pharmaceutical Sciences
      Musashino University, Japan
  • 11:00AM - 12:30PM (Tokyo Standard Time)

    [V6-S2] ARO Activities to Facilitate Late-Phase Clinical Trials in Asia


    Session Chair(s):

    • No-image Koichi Miyazaki, MSc, RPh
      Senior Director, Regulatory Affairs Group, Asia Development Dept
      Daiichi Sankyo Co., Ltd., Japan

    Speaker(s):

    • Evolution of the Clinical Trial Consortium in South Korea
      Moo Hyun Kim, MD, PhD, FACC
      Director, Global Clinical Trial Center
      Dong-A University, Korea, Republic of
    • Clinical Trial Consortium in Taiwan
      K. Arnold Chan, MD, FISPE
      Director, Clinical Trial Center
      National Taiwan University Hospital, Taiwan
    • ARO Activities to Facilitate Late-Phase Clinical Trial in Japan
      Hideki Hanaoka
      Director of Clinical Research Center
      Chiba University Hospital, Japan
  • 2:00PM - 3:30PM (Tokyo Standard Time)

    [V1-S3] Global Contribution for Clinical Development from Japan


    Session Chair(s):

    • Naomi Nagai, PhD
      Senior Specialist for Pharmacokinetics
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • No-image Masayo Oishi, PhD
      Clinical Pharmacologist, Clinical Pharmacology, Clinical Research
      Pfizer Japan Inc., Japan

    Since the “Basic Principles on Global Clinical Trials” was implemented in 2007, the Japanese tactic to participate in early global development has been actively discussed and the simultaneous approvals utilizing this concept have become reality. In this session, as a next step of participation in multi regional clinical trials, presenters will provide ideas of how can Japan actively contribute to global clinical development. In the panel discussion, the values that Japan can provide to global clinical development will be discussed based on the ideas in the presentations.

    Speaker(s):

    • Meaningful Asian Phase I for GlobalDrug Development
      Koji Chiba, PhD
      Professor, Laboratory of Clinical Pharmacology
      Yokohama College of Pharmacy, Japan
    • Advanced PET Molecular Imaging Technology for the Drug Development from Pharmacokinetics and DDS to Super-early Diagnosis
      Tomotaka Shingaki
      Research Scientist, Molecular Dynamics Imaging Unit
      RIKEN Center for Life Science Technologies, Japan
    • Public-private partnership in Japan for global clinical development-Present status and operational challenges
      Yuji Sato, MD, PhD
      Centre for Clinical Research
      Keio University School of Medicine, Japan
  • 2:00PM - 3:30PM (Tokyo Standard Time)

    [V2-S3] How Can We Apply the Electric Health Records for Postmarketing Drug Safety in Japan?


    Session Chair(s):

    • Kiyoshi Kubota, MD, PhD, FISPE
      Professor, Department of Pharmacoepidemiology
      The University of Tokyo, Japan
    • Chieko Ishiguro, MPH
      Pharmacoepidemiologist, Office of Safety I
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    Recently in Japan, the secondary use of some Electronic Health Records (EHR) databases has been made available for postmarketing drug safety. In this session, speakers from a regulatory agency, academia, and a pharmaceutical industry organization will discuss postmarketing drug safety using EHR. At the end of the session, we will have a panel discussion focusing on current issues and the future direction of postmarketing drug safety by using EHR in Japan.

    Speaker(s):

    • How can we apply the electric health records for Post-Marketing Safety Measures-MIHARI Project & MID-NET-
      Maki Komamine
      Pharmacoepidemiologist
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Remarks from the Academic Viewpoint
      Takuhiro Yamaguchi, PhD
      Professor
      Tohoku University Graduate School of Medicine, Japan
    • Thoughts from a pharmaceutical industry perspective
      Kotonari Aoki
      Manager
      Chugai Pharmaceutical Co., Ltd., Japan
    • TheParadigmwithout Japanese style Post-marketing Surveillance (PMS)
      Tatsuo Kagimura, MPH
      Translational Research Informatics Center, Japan
  • 2:00PM - 3:30PM (Tokyo Standard Time)

    [V3-S3] Lessons Learned of Adaptive Design from Case Example


    Session Chair(s):

    • Yasuo Ohashi, PhD
      Professor, Dept of Integrated Science & Engineering for Sustainable Society
      Chuo University, Japan

    Speaker(s):

    • An Adaptive, Seamless Phase 2/3 Study Incorporating a Clinical Utility Index
      Zachary Kulkarni Skrivanek, PhD
      Principal Research Scientist, Global Statistical Sciences
      Eli Lilly and Company, United States
    • Experience of Sample Size Re-estimation for Registration Studies in Japan
      Shintaro Hiro, PhD
      Clinical Statistics
      Pfizer Japan Inc., Japan
    • A Regulatory Perspective on the Use of Adaptive Design in Drug Development
      Hiroyuki Sato
      Reviewer
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • 2:00PM - 3:30PM (Tokyo Standard Time)

    [V4-S3] Innovation in Development of Orphan Drugs (1) — Status Quo of Designation Scheme and Academia


    Session Chair(s):

    • Yasuhiro Kanatani
      Director, Dept of Health Crisis Management
      National Institute of Public Health, Japan
    • Satoru Hayata
      Head of Rare Diseases Medicine Development Centre
      GlaxoSmithKline K.K., Japan

    The designation scheme for orphan drugs was established in 1993 in Japan, and since them, various incepted have been provided for the development of orphan drugs. Recently, because of recent medical and scientific advancement, advanced technologies have significantly evolved and medical views on unmet medical needs are becoming diversified. Expectations for drug discovery research will be much higher in the future. This session consists of two parts. Members will hear regulatory viewpoints from the authorities about scheme of “Orphan designate system” and any activities by academia to discuss how to improve the status in orphan drug development in Japan. Moreover, various business models in orphan development will be shared, for example NPO’s activity to introduce a new drug in Japan.

    Speaker(s):

    • Japan Status on Orphan Designation - Past, Present and Future Views
      Daiju Okuda
      Evaluation and Licensing Division
      Ministry of Health, Labour and Welfare, Japan
    • Current Situation of Investigator Initiated Development of Orphan Drugs - Approaches from Academia
      Masanori Fukushima, MD, PhD
      Director
      Translational Research Informatics Center, Japan
    • An Alternative Approach in Development of Orphan Drugs - KOINOBORI Drug Development Support Program -
      Taro Inaba
      KOINOBORI Associate Inc., Japan
  • 2:00PM - 3:30PM (Tokyo Standard Time)

    [V6-S3] Management of COI in Clinical Trials and Future Perspective


    Session Chair(s):

    • Yasuhiro Fujiwara, MD, PhD
      Director, Strategic Planning Bureau
      National Cancer Center, Japan
    • No-image Hiroshi Watanabe, MD, PhD
      Professor, Dept of Clinical Pharmacology & Therapeutics
      Hamamatsu University School of Medicine, Japan

    Drug development is a collaborative work between investigators and pharmaceutical industries. Since the existence of COI is inevitable, managing COI in the conduct of clinical trials is needed to ensure the integrity of the research and to protect the welfare of human subjects. Based on the identification of COI, the nature and source of funding and financial incentives offered to the investigators must be disclosed to a participant in a clinical trial and ethics committee. Unfortunately, there are serious misconducts of clinical trials lacking the quality and reliability of data collected and concealing COI in Japan. This session will discuss the strategies for overcoming the drawbacks in clinical trials in Japan, especially the rational management of COI.

    Speaker(s):

    • Management of COI in Clinical Trials and Future Perspective
      Saburo Sone, MD, PhD
      Executive Managing Director
      Tokushima Municipal Hospital, Japan
    • Management of COI in Clinical Trials from Investigator's Point of View
      Yasuhiro Fujiwara, MD, PhD
      Director, Strategic Planning Bureau
      National Cancer Center, Japan
    • Management of COI in Clinical Trials from Sponsor's Point of View
      Masakazu Kitagawa
      ACRONET Corporation, Japan
  • 2:00PM - 3:30PM (Tokyo Standard Time)

    [V5-S3] Brain Storming How We Can Conduct Clinical Trials - A Company-Funded Company-Lead Trial is Not Only the Way to Run a Clinical Trial


    Session Chair(s):

    • Tomoko Hirohashi, PhD
      Director, Clinical Research Oncology
      Pfizer Japan Inc., Japan

    Speaker(s):

    • Brain Storming How We Can Concudt Clinical Trials? A Company-Funded Company-Lead Trials is Not Only the Way to Run a Clinical Trial? - Introduction
      Tomoko Hirohashi, PhD
      Director, Clinical Research Oncology
      Pfizer Japan Inc., Japan
    • Clinical Development Strategy Including Company-Initiated Clinical Study
      Tomio Nakamura
      Senior Director, Japan/Asia Clinical Development Oncology Group
      Eisai Co., Ltd., Japan
    • Drug development based on the collaboration between Academia and the companies- Proposal and requests from Academia-
      Koichi Goto, MD, PhD
      Chief, Division of Thoracic Oncology
      National Cancer Center Hospital East, Japan
    • Experience of Collaboration with External Partners - The Case of Non-Domestic Company -
      Akihira Mukaiyama, MSc
      Manager, Medicines Development, Development & Medical Afffairs Division
      GlaxoSmithKline K.K., Japan
  • 4:00PM - 5:30PM (Tokyo Standard Time)

    [V1-S4] Virtual Meeting of PMDA’s Scientific Consultation: Points to Maximize an Efficiency of the Meeting


    Session Chair(s):

    • No-image Yoshiaki Uyama, PhD
      Director, Division of Epidemiology, Office of Safety I
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    It is critical for both applicant and regulator to have a proper understanding of the objectives of a consultation, including the background or fundamental problems faced in order to make a productive discussion in the scientific consultation or NDA review process possible. In reality, however, the usefulness or comprehension varies depending on how the issues are addressed or how the opinions are written in the briefing or response materials. This session will focus on PMDA scientific consultation. In this session, the panelists will replicate typical consultation by using virtual new product. This will provide some ideas on how to avoid miscommunication and how to maximize the value of consultation. The panelists acting as applicants will replicate the process how they decide their response policy to the inquiry from PMDA and how they find a compromise. Conversely, panelists acting as PMDA will disclose the heated internal discussion that isn’t open to the public. Just as in last year’s session, the session will use a voting system. Other topics of discussion include CMC, nonclinical study, and phase III study including multiregional clinical trial, among others.

  • 4:00PM - 5:30PM (Tokyo Standard Time)

    [V2-S4] What is the Benefit-risk Balance Assessment which Japan is Aiming for? - Strategy for Generation of Useful Information which Contributes to Patients


    Session Chair(s):

    • No-image Rei Maeda
      Senior Regulatory Scientist, Surveillance & Epidemiology, Global Patient Safety
      Eli Lilly Japan K.K., Japan

    These sessions have covered benefit-risk balance assessment in previous annual meetings held in Japan. However, there were few opportunities to convey the Japanese approach for benefit-risk balance assessment to the world. In this session, we will reaffirm the relationship between BRMP and PBRER, which are fundamental to benefit-risk balance assessment and its periodic report. Subsequently we will get a better understanding of the current status of the leading countries. Furthermore, we will discuss Japanese future vision, and share opinions about the contribution to patients from the global viewpoint.

    Speaker(s):

    • Positioning Benefit-risk Balance Assessment in Japan - From Company's Point of View
      Osamu Komiyama
      Senior Manager, Statistical Research & Consulting Group, Clinical Statistics
      Pfizer Japan Inc., Japan
    • Current Situation of Benefit-risk Balance Assessment in EMA
      Francesco Pignatti, MD
      Head of Oncology, Haematology, Diagnostics
      European Medicines Agency, European Union , United Kingdom
    • Possibility of Medical Big Data
      Patrick Frey
      Director, Office of Program and Strategic Analysis, CDER
      FDA, United States
    • The Future Direction of Japan Regarding Benefit-risk Balance Assessment
      Akiko Hori, MD, PhD
      Review Director, Office of Safety II
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • 4:00PM - 5:30PM (Tokyo Standard Time)

    [V3-S4] Innovation of Clinical Development with Maximum Use of Existing Data


    Session Chair(s):

    • No-image Eri Sekine
      Head of Oncology Biometrics and DM Department, Oncology Development
      Novartis Pharma K.K., Japan

    Speaker(s):

    • PK/PD Modeling & Simulation Using Physiologically-based Pharmacokinetic Model
      Hidefumi Kasai
      Certara G.K., Japan
    • What Advantage Can Clinical Trial Designs to Optimize Existing Information give us?
      Tomoyuki Kakizume, PhD
      Novartis Pharma K.K., Japan
    • Modeling & Simulation in Drug Development for Pediatric or Rare Diseases
      Naoki Isogawa, PhD
      Pfizer Japan Inc., Japan
  • 4:00PM - 5:30PM (Tokyo Standard Time)

    [V5-S4] Introduction to the Role of Medical Affairs for Research and Development Department


    Session Chair(s):

    • Taku Seriu, MD, PhD
      Executive Operating Officer, Head of New Product Evaluation & Development
      Otsuka Pharmaceutical Co., Ltd., Japan
    • No-image Takeharu Yamanaka, PhD
      Professor, Department of Biostatistics
      Yokohama City University School of Medicine, Japan

    How to facilitate the Medical Affairs department (MA) is currently a topic of ongoing debate in Japanese Pharmaceuticals. In contrast to Europe and the US, where the role and contribution of MA is established, opportunities for collaboration with MA in Japan to let R&D department know the role of MA has been somewhat limited. The purpose of this session is to provide a basic understanding of the function of MA, focusing mainly on its relevance to the R&D department, as well as the process of product life cycle management as a whole.

    Speaker(s):

    • Introduction to the Role of Medical Affairs for Research and Development Department Role of Medical Affairs after Launching Products
      Kazuya Iwamoto, MD, PhD
      Director, Medical Affairs
      Biogen Idec Japan Ltd., Japan
    • Role of Medical Affairs in Development Phase
      Masahiro Tamura
      Head, Post Marketing Clinical Research, Medical Operations
      Sanofi K.K., Japan
    • Medical Affairs Department in Japan: Current Status and Issues
      Eiji Harada, MD, MBA
      Clinical Research Physician, Medicines Development Unit
      Eli Lilly Japan K.K., Japan
    • Medical Affairs Department in Japan: Current Status and Issues
      Kouji Iwasaki, PhD
      Director, Global Medical Affairs, Japan Department
      Takeda Pharmaceutical Company Limited, Japan
  • 4:00PM - 5:30PM (Tokyo Standard Time)

    [V6-S4] Application of Lean Six Sigma in DM Process Improvement in an Investigator Initiated Clinical Trial


    Session Chair(s):

    • Yoichi M. Ito, PhD
      Associate Professor, Department of Biostatistics
      Hokkaido University Graduate School of Medicine, Japan

    Speaker(s):

    • Introduction of Lean Six Sigma - A Systematic Approach for Problem Solving
      Hirotaka Inoue
      Head, Leading Changes Office, Japan Development & Medical Affairs
      GlaxoSmithKline K.K., Japan
    • Data Management process improvement in an investigator initiated clinical trial using Lean Six Sigma: Part I
      Aya Uchiyama
      Technical Assistant, Div of Clinical Trial Management, Center for
      Hokkaido University, Japan
    • DM Process Improvement in an Investigator initiated Clinical Trial Using Lean Six Sigma (Part II)
      Tomoko Kubota
      Japan Development & Medical Affairs Medicines Development
      GlaxoSmithKline K.K., Japan
  • 4:00PM - 5:30PM (Tokyo Standard Time)

    [V4-S4] Innovation in Development of Orphan Drugs (2) — Diversifying Type of Operation and Companies


    Session Chair(s):

    • Satoru Hayata
      Head of Rare Diseases Medicine Development Centre
      GlaxoSmithKline K.K., Japan
    • Yasuhiro Kanatani
      Director, Dept of Health Crisis Management
      National Institute of Public Health, Japan

    In the second part of this session, various business models in orphan development will be shared, such as a new business model by CRO, and approaches to development of ultra orphan drugs by respective companies. Conventional development strategies and methods may not be efficient in this field, and approaches with new innovative ideas would be necessary. We could hear how to think development strategy of orphan drugs from regulator’s point of view, and discuss how to more improve the status including thinking of new business model in orphan drug development.

    Speaker(s):

    • Development of Orphan Drugs - Regulatory Viewpoints from PMDA
      Ken Sakushima, MD, PhD
      Specially Appointed Expert, Office of Cellular and Tissue-based Products
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • New Business Model for the Development and Market Launch of Orphan Drugs
      Hiroshi Kosaku
      Senior Corporate Officer
      CMIC HOLDINGS Co., Ltd., Japan
    • Development of Ultra Orphan Drugs and It's Advancement
      Shigeki Shimasaki
      Executive Officer, COO of R&D
      Nobelpharma Co., Ltd., Japan
    • Orphan drug development in Genzyme Japan
      Masaki Osawa
      Regulatory Affairs
      Genzyme Japan K.K., Japan
  • 5:45PM - 7:00PM (Tokyo Standard Time)

    Let’s Chat! – Presented by DIA Community


    Session Chair(s):

    • No-image Eri Sekine
      Head of Oncology Biometrics and DM Department, Oncology Development
      Novartis Pharma K.K., Japan

Day 3 Tuesday, Nov 18, 2014

  • 9:00AM - 10:30AM (Tokyo Standard Time)

    [V1-S5] Commercialization of Regenerative Medical Products and Quality Assurance


    Session Chair(s):

    • Teruo Okano, PhD
      Professor, Institute of Advanced BioMedical Engineering and Science
      Tokyo Women's Medical University, Japan
    • Akihiro Umezawa, MD, PhD
      Deputy Center Director for Cellular and Tissue-based Products
      Pharmaceutical and Medical Devices Agency (PMDA), Japan

    In Japan, the development of regenerative medical products is expected to grow. This session consists of two parts. In the first part, the current situation and the challenges from development to commercialization for regenerative medical products will be explained from the viewpoint of industry, government, and university. Then, in the panel discussion, we will discuss the challenges at the early developmental stage (donor, autologous/allogenic cells), clinical stage (outsourcing for cell growth and storage under new law) and application stage (GMP and the Standards for Bioderived Raw Materials).

    Speaker(s):

    • Japanese Regulations for Quality and Safety of Regenerative Medicine and Cell Therapy
      Yoji Sato, PhD
      Head, Division of Cellular and Gene Therapy Products
      National Institute of Health Sciences, Japan
    • Quality control of cell processed product from autologous somatic cells
      Toshiyuki Owaki, PhD
      Associate Professor, Institute of Advanced Biomedical Engineering & Science
      Tokyo Women's Medical University, Japan
    • Challenge to quality control of autologous cell products for regenerative medicine through experience from JACE? and JACC?
      Kenichiro Hata
      Japan Tissue Engineering Co., Ltd., Japan
  • 9:00AM - 10:30AM (Tokyo Standard Time)

    [V5-S5] Risk-based Approach to Monitoring — Part 1: Current Status and Outlook


    Session Chair(s):

    • Naoyuki Yasuda
      Director, Office of Non-Clinical and Clinical Compliance
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Yuji Fukuda
      Manager, Clinical Operation
      Eli Lilly Japan K.K., Japan

    In Japan, the risk-based approach to monitoring (RBM) has been presented mainly as an outline. However, the pilot studies have been conducted mainly by industries whose headquarters are located outside of Japan. And an aggressive discussion for RBM implementation has been done, even though the pilot studies have not been conducted. At this session, we will update the current status of RBM implementation through questionnaires to the pharmaceutical industry. In addition, we will discuss the outlook of RBM implementation, including both sponsor and investigational site view.

    Speaker(s):

    • Current Status of RBM Implementation in Japan
      Reiko Oku
      Teijin Pharma Ltd., Japan
    • Points to Consider for RBM Implementation: A View from Investigational Site
      Yukiko Enomoto
      Clinical Research Center
      Nihon University Itabashi Hospital, Japan
    • The Expectations for Institutions and the Proposal from Sponsors on RBM
      Yuri Kitayama
      Clinical Research Associate
      Otsuka Pharmaceutical Co., Ltd., Japan
    • Items to be Covered by the Sponsor at the Study Preparation Phase
      Ryoichi Muraoka, DVM
      Data Science Team Leader, Clinical Development Department
      Ajinomoto Pharmaceuticals Co., Ltd., Japan
  • 9:00AM - 10:30AM (Tokyo Standard Time)

    [V6-S5] Genomic Sampling Over Generations


    Session Chair(s):

    • Akihiro Ishiguro, PhD
      Principal Reviewer, Office of New Drug V
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    Speaker(s):

    • Pharmacogenetics Research Based on the Biobank Japan Project
      Michiaki Kubo, MD, PhD
      Deputy Director, Center for Integrative Medical Sciences
      RIKEN, Japan
    • Valuable Genomic Sampling and Storing from Clinical Trials for Drug Development
      Koji Suematsu, MS
      Manager, PGx, Clinical Development
      Taisho Pharmaceutical Co., Ltd., Japan
    • Ethical issues of research with PGt/PGxsamples collected in clinical trials
      Kenji Matsui, MD, PhD
      Head, Office for Research Ethics & Bioethics
      The National Cerebral and Cardiovascular Center, Japan
    • Genomic Sampling Methodologies for Future Use
      Yu Sakamoto
      Reviewer, Office of New Drug III
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • 9:00AM - 10:30AM (Tokyo Standard Time)

    [V2-S5] Is the Risk Management Plan Really Effective? Part I


    Session Chair(s):

    • Takuko Sawada
      Senior Vice President, Global Development, Pharmaceutical Development Div
      Shionogi & Co., Ltd., Japan
    • No-image Junko Sato, DrSc, PhD
      Director, Division of Regulatory Cooperation, Office of International Programs
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    The RMP was introduced last April in Japan. Although the framework of postmarketing safety measures appears to be consolidated, there were not many discussions on RMP contents; it is often said that Japan’s postmarketing system remains basically unchanged. Now, RMPs of over 20 products were published on the PMDA website. Both companies and regulatory authorities have accumulated experience on RMPs, and it is highly beneficial to set up a forum for exchanging issues about RMPs and share them among relevant parties, including health care professionals. In this session, we will discuss the problems of RMPs and pharmacovigilance plans, which are clinically meaningful, and to explore the possibility of cooperation of better postmarketing safety measure for well-considered benefit-risk balance.

    Speaker(s):

    • From New Drug Reviewer's Point of View
      Naoyuki Yabana, PhD
      Review Director, Office of New Drug III
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • From Japanese Company’s Point of View
      Yomei Matsuoka, MSc
      Senior Director, Safety Evaluation & Planning Group IV, Pharmacovigilance Dept
      Daiichi Sankyo Co., Ltd., Japan
    • From Foreign Company's Point of View
      Lyo Inuyama
      Operating Officer, Medical Director, Head of Medical Affairs
      Bayer Yakuhin, Ltd., Japan
    • RMP Review: From PMDA Safety Perspective
      Noriyuki Komiyama
      Office of Safety II
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • 9:00AM - 10:30AM (Tokyo Standard Time)

    [V3-S5] Multi-Regional Clinical Trials: Where Should it Be Headed?


    Session Chair(s):

    • No-image Hironobu Saito, PhD
      VP, New Drug Regulatory Affairs Dept.
      Daiichi Sankyo Co., Ltd., Japan

    Speaker(s):

    • Advancing Roles of Japan on Global Drug Development
      Yoshiaki Uyama, PhD
      Director, Division of Epidemiology, Office of Safety I
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Proposal for Interpreting the Resuts from MRCT and Its Reflection onto the MRCT Planning
      Osamu Komiyama
      Senior Manager, Statistical Research & Consulting Group, Clinical Statistics
      Pfizer Japan Inc., Japan
  • 9:00AM - 10:30AM (Tokyo Standard Time)

    [V4-S5] Fostering Superior Talents involved in Drug Development and Evaluation - The Necessity of “Human Resource Development” and “People-to-people Exchange” beyond Boundaries


    Session Chair(s):

    • No-image Junichi Nishino, MSc, RPh
      Head, Regulatory Operation & Prescribing Information Group, Drug RA Dept.
      Novartis Pharma K.K., Japan

    Required ideal talent is changing with the change of the times, and human resource development plan should be mapped out or revised in anticipation of the trend of drug development strategy, regulation and/or environmental change with information technology. The current trends require persons who can demonstrate their ability at the international stage of simultaneous global development, but what will the trends be after 10 years? In this session, the responsible persons for training/ human development in academy, industry, and government (PMDA) will talk about their successful experiences, issues to overcome, and ideal settings. In the panel discussion, we would like to discuss benefits, difficulties, and importance of exchanging human resources among academy, industry, and PMDA. We hope this session will inspire young associates who have uncertainty about the future career path and managers who are distressed about their subordinate’s human/career development.

    Speaker(s):

    • Human resource development and Personnel exchanges in PMDA
      Tomoko Ohsawa, PhD
      Director for Personnel Coordination, Office of General Affairs
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Fostering Superior Talents involved in Drug Development and EvaluationNeed for Human Resource Development and Interaction Across Boundaries -From Industry prospective-
      Keiko Ebihara, PhD
      Director, Regulatory Affairs and Market Access
      Abbott Japan Co., Ltd., Japan
    • Human resource development in academia:toward an effective industry-government-academia collaboration
      Akihiro Hirakawa, PhD
      Biostatistician, Center for Advanced Medicine and Clinical Research
      Nagoya University Hospital, Japan
  • 11:00AM - 12:30PM (Tokyo Standard Time)

    [V1-S6] Expectation and Challenge for Regenerative Medical Products Development - What is Changed Based on the Revision of Pharmaceutical Affairs Law?


    Session Chair(s):

    • Teruo Okano, PhD
      Professor, Institute of Advanced BioMedical Engineering and Science
      Tokyo Women's Medical University, Japan
    • Akihiro Umezawa, MD, PhD
      Deputy Center Director for Cellular and Tissue-based Products
      Pharmaceutical and Medical Devices Agency (PMDA), Japan

    In Japan, the development of regenerative medical products is expected to grow. This session consists of two parts. In this second part, we will focus on the new regulation of regenerative medical products. The revision of the Pharmaceutical Affairs Law will be effective at the end of November, 2014. Under this revised law, a new approach is expected to develop innovate regenerative medical products and accelerate the derivation of them for the patient. In the panel discussion, we will consider what we are able to change in Japan using this new system.

    Speaker(s):

    • Exposition of New Regulation in theRevision of Pharmaceutical AffairsLaw -For Correct Understanding of“Conditional & Time Limited Approval”
      Daisaku Sato, PhD
      Director, Office of Cellular and Tissue-based Products
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Expectation and Challenge for“Regenerative Medical Product”Development from View of a Japanese Academia
      Kiyoshi Okada
      Project Associate Professor
      Osaka University, Japan
    • Expectation and Challenges for Regenerative Medical Product Development: a Japanese biotech company’s perspectives
      Kunihiko Suzuki
      Member of the Board
      MEDINET Co., Ltd., Japan
    • Global Development of Regenerative Medicines: Opportunities for Accelerated Approval Pathways and Challengesof Global Development
      Katherine Tsokas, JD
      Senior Director, Global Regulatory Affairs
      Janssen Research and Development, LLC, United States
  • 11:00AM - 12:30PM (Tokyo Standard Time)

    [V2-S6] Is the Risk Management Plan Really Effective? Part II


    Session Chair(s):

    • Takuko Sawada
      Senior Vice President, Global Development, Pharmaceutical Development Div
      Shionogi & Co., Ltd., Japan
    • No-image Junko Sato, DrSc, PhD
      Director, Division of Regulatory Cooperation, Office of International Programs
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    The RMP was introduced in last April in Japan. Although the framework of postmarketing safety measures appears to be consolidated, there were not many discussions on RMP contents; and it is often said that Japan’s postmarketing system remains basically unchanged. Now, RMPs of over 20 products were published on the PMDA website. Both companies and regulatory authorities have accumulated experience on RMPs, and it is highly beneficial to set up a forum for exchanging issues about RMPs and share them among relevant parties, including health care professionals. In this session, we will discuss the problems of RMPs and pharmacovigilance plans, which are clinically meaningful, and explore the possibility of cooperation of better postmarketing safety measure for wellconsidered benefit-risk balance.

    Speaker(s):

    • From Medical Spot of View
      Masaaki Mori
      Associate Professor, Department of Pediatrics
      Yokohama City University Hospital, Japan
  • 11:00AM - 12:30PM (Tokyo Standard Time)

    [V3-S6] Beyond Japan: From Asian Studies to Global Studies


    Session Chair(s):

    • Shintaro Omuro, MSc
      Manager
      Astellas Pharma Inc., Japan

    Although various pharmaceutical companies have now accumulated experience in Asian multinational studies and global studies, such exposure is still only limited to certain members (e.g., members from the Asian Development Department, or members working on global studies). During this multinational session, the pros and cons of Japan local study, Asian study and global study will be discussed by three experts from clinical development, regulatory, and CRO. A panel discussion will also take place subsequently to highlight recent issues and to discuss how to solve them with the most current knowledge. Participants who previously focused only on Japan local development are also welcome. The goal of this session is to provide useful hints and tips for you to consider in your clinical development strategy in the near future.

    Speaker(s):

    • Think about Asian Studies and Global Studies-From Regulatory Perspective -
      Ari Fujishiro
      Associate Director, Regulatory Affairs Group, Asia Development Dept
      Daiichi Sankyo Co., Ltd., Japan
    • Effcient Collaboration of Asian and Global Development - From Clinical Development Perspective -
      Yu Hasegawa, MSc
      Asian Development
      Astellas Pharma Inc., Japan
    • Optimizing Collaboration with Global CROs in Asian and Global Studies
      Tetsu Yung
      Senior Project Manager, Clinical Development Services
      Covance Japan, Japan
  • 11:00AM - 12:30PM (Tokyo Standard Time)

    [V4-S6] Seeking for the Future Prosperity for Both Pharmaceutical Company and CRO


    Session Chair(s):

    • No-image Shogo Nakamori, PharmD, MBA
      Corporate VP, CRS, Asia-Pacific & GM Japan County Operation
      PAREXEL International, Japan
    • No-image Hiroshi Kosaku
      Senior Corporate Officer
      CMIC HOLDINGS Co., Ltd., Japan

    The CRO industry in Japan has been growing for more than 20 years and is now firmly established in the pharmaceutical arena. The next step is to create a partnership for both pharmaceutical companies and CRO to prosper. Both parties need to consider past experience, including its successes and failures, during the course of actual operation. While placing high importance on the efficiency of clinical trials with maintaining the quality and integrity of the data, such as Risk-based Monitoring, it is obvious that we cannot discuss future prosperity for both parties without further mutual understanding. In this session, we will discuss the future relationship between pharmaceutical companies and CRO by exchanging and sharing ideas with industry panelists.

    Speaker(s):

    • Further development of collaboration between CROs and Pharmaceuticals
      Naohisa Yokota
      Corporate Officer, Research & Development
      Sanofi K.K., Japan
    • Suggestions to CRO from Clients Side
      Yoko Ishige
      Team Leader, CNS Group Clinical Operation
      Dainippon Sumitomo Pharma Co., Ltd., Japan
    • Suggestions to Clients from CRO Side
      Shogo Nakamori, PharmD, MBA
      Corporate VP, CRS, Asia-Pacific & GM Japan County Operation
      PAREXEL International, Japan
  • 11:00AM - 12:30PM (Tokyo Standard Time)

    [V5-S6] Risk-based Approachto Monitoring — Part 2: Implementation Status of TransCelerate Member Companies in Japan


    Session Chair(s):

    • Naoyuki Yasuda
      Director, Office of Non-Clinical and Clinical Compliance
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Yuji Fukuda
      Manager, Clinical Operation
      Eli Lilly Japan K.K., Japan

    In 2012, TransCelerate BioPharma Inc., a company composed mainly of western companies, was established for the purpose of promoting the efficiency of clinical development activities. Some documents and tools, including a position paper for RBM, have been issued by TransCelerate, and they have been referred to as standard concepts and approaches for RBM implementation. In this session, representatives from member companies in TransCelerate will provide case studies of RBM in Japan.

    Speaker(s):

    • RBM Challenges Focused on Study PreparationStage in Asian Study
      Yosuke Kubota
      Astellas Pharma Inc., Japan
    • Risk Based MonitoringCase of GlaxoSmithKline
      Masayuki Kanezaki
      Manager
      GlaxoSmithKline K.K., Japan
    • Risk-Based Monitoring in BMS
      Yumi Ichimoto
      Regional Clinical Operations Japan
      Bristol-Myers K.K., Japan
    • Risk Based Monitoring Methodology
      Junichi Hamada
      Nippon Boehringer Ingelheim Co., Ltd., Japan
  • 11:00AM - 12:30PM (Tokyo Standard Time)

    [V6-S6] New Relationship of Drugs and Medical Devices Will Open up the Future of the Health Care


    Session Chair(s):

    • Koji Ikeda, PhD
      Professor, Clinical Research, Innovation and Education Center
      Tohoku University Hospital, Japan

    Even in the therapeutic area where medical treatment by drugs has been traditionally common the treatment by medical devices has started for the patients who are resistant to treatment by drugs. Further such medical devices like PDT Laser and Vascular Embolization Beads which increase effectiveness of medical treatment when used together with drugs have been used for treatment of certain cancer which has been traditionally difficult to treat. As above, beyond combination products such as drug eluting stent the innovative combined usage of drug and medical devices has opened new phase of opportunities for new medical treatment As combined usage of drugs and medical devices is getting more complex how to evaluate the clinical benefit of such combined products is also getting complex. Since the criteria of clinical evaluation is different between drugs and medical devices because of their product characteristics it is important to start discussion for clinical evaluation criteria and methodology for new medical treatment by combined usage of drugs and medical devices.

    Speaker(s):

    • Considering Drug and Device on the Clinical Trial Process
      Isao Tsuchii
      Business Operator
      Green Field, Japan
    • The Future of Clinical Evaluations for Pharmaceuticals and Medical Devices
      Naoyuki Makuta
      CEO
      Mediwrite Co., Ltd., Japan
    • Difference of Medical Devices and Drugs in Clinical Trials Planning
      Masato Nakamura, MD, PhD
      Professor, Division of Cardiovascular Medicine
      Toho University Ohashi Medical Center, Japan
    • Clinical Evaluation: Comparison of Medical Devices and Drug
      Yuka Suzuki, PhD
      Director, Office of Medical Devices II
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • 1:50PM - 2:50PM (Tokyo Standard Time)

    Special Session: Medical Contributions With A New Perspective That Transcends Boundaries


    Session Chair(s):

    • No-image Kazuhiko Mori, MSc
      Director, Evaluation & Licencing Div, Pharmaceutical & Food Safety Bureau
      Ministry of Health, Labour and Welfare, Japan

    Robot Suit HAL is the world’s first cyborg-type robot developed by full use of Cybernics which is a new academic field (fused and interdisciplinary technology related to human, machine and information) consisting of neuroscience, motor physiology, robotics, information technology, behavior science, system integration technology, law, ethics and business management. HAL enhances and strengthens the limb motion of its wearer by detecting the weak bioelectrical signals through the body from the brain which generates the nerve signal to control the musculoskeletal system and promotes treatment for functional improvement, regeneration and acquisition for disabled people by spinal cord injury or stroke and also supports self-independent motion like activity of daily life and nursing-care motion when care-giver lifts patients. HAL has obtained CE marking, the certificate for all EU countries, as the first robotic therapeutic device and in Germany, application of public workers’ compensation insurance to cover the costs of using HAL for medical treatment has been implemented. Now, medical contributions with a new perspective that transcends boundaries are accelerating by research and development in the field of new combined therapies such as HAL therapy with regenerative medicine and/or pharmaceuticals.

    Speaker(s):

    • Yoshiyuki Sankai, PhD
      Professor, Graduate School of Systems & Information Engineering
      The University of Tsukuba, Japan
  • 2:50PM - 3:00PM (Tokyo Standard Time)

    Best Presenter/Student Award
  • 3:30PM - 5:00PM (Tokyo Standard Time)

    Round Table: What are Expectations for “Adaptive Licensing"?


    Session Chair(s):

    • No-image Kazuhiko Mori, MSc
      Director, Evaluation & Licencing Div, Pharmaceutical & Food Safety Bureau
      Ministry of Health, Labour and Welfare, Japan
    • No-image Yoshihiko Ono
      Executive Director, Head of Regulatory Affairs, Japan Development
      MSD K.K., Japan

    Adoptive Licensing (AL) is getting much attention as a system for improving access to new medicines or medical technologies with high medical needs. The EMA has already considered Medicine’s Adaptive Pathways (MAPs) or Medicine’s Adaptive Pathways to Patients (MAPPs) and launched a pilot project. In Japan, the Act on the Safety of Regenerative Medicine was enacted, permitting early approval of tissue-engineered medical products, which is thought to be a kind of AL. When institutionalizing AL, how far efficacy and safety should be ensured in order to permit access to medicines based on limited data, as well as how to assess the risks and benefits, are all important issues. In this session, we’ll grasp the benefits and the problems of AL and discuss the expected system.

    Speaker(s):

    • Implementation of Adaptive Licensing in Europe
      Francesco Pignatti, MD
      Head of Oncology, Haematology, Diagnostics
      European Medicines Agency, European Union , United Kingdom
    • Perspective on the Regulatory Schema of the Adaptive Licensing for Pharmaceuticals
      Daisaku Sato, PhD
      Director, Office of Cellular and Tissue-based Products
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Moving Forward To New Paradigm~ Adaptive Approach ~
      Hiromichi Shirasawa, MD
      Vice President and Executive Officer, Head of Japan Development
      MSD K.K., Japan
  • 3:30PM - 6:25PM (Tokyo Standard Time)

    PMDA Town Hall


    Session Chair(s):

    • Tomiko Tawaragi
      Chief Safety Officer
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • No-image Hiroshi Watanabe, MD, PhD
      Professor, Dept of Clinical Pharmacology & Therapeutics
      Hamamatsu University School of Medicine, Japan

    Speaker(s):

    • Kensuke Ishii, PhD
      Office of Medical Devices III
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Yoshiko Komuro, PhD
      Deputy of Review Director, Office of New Drug II
      Pharmaceutical and Medical Devices Agency (PMDA), Japan
    • Emiko Kondo
      Director, Office of Conformity Audit
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Michiyo Sakiyama
      Office of New Drug V
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Daisaku Sato, PhD
      Director, Office of Cellular and Tissue-based Products
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Yasunori Yoshida
      Director, Office of Review Management
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • 6:25PM - 6:30PM (Tokyo Standard Time)

    Closing Remarks

    Speaker(s):

    • Hiroshi Watanabe, MD, PhD
      Professor, Dept of Clinical Pharmacology & Therapeutics
      Hamamatsu University School of Medicine, Japan

Exhibits  

The 11th Annual Meeting DIA Japan 2014 offers interested companies following exhibit and support opportunities.

  • Gold Supporter - ¥734,400
  • Silver Supporter - ¥237,600
  • Industry Exhibit Booth Space (2475 x 2475 mm) - ¥432,000
  • Academia Tabletop Space (2300 x 1400 mm) - ¥108,000
  • Premium Coffee Service - ¥108,000
  • Program Adversitment Insertions (see brochure for pricing)
  • Congress Bag Insert - ¥32,400
  • Banner Advertisement - ¥216,000
  • Cyber Lounge - ¥216,000

All prices include 8% Consumption Tax

Useful Links:

  • ADM Korea Inc.
  • ArisGlobal KK
  • ASKLEP Inc.
  • BioClinica Inc.
  • C3i Inc.
  • Capital Medica Co., Ltd.
  • CDISC
  • Cenduit Japan
  • Chiba University Hospital Clinical Research Center
  • CMIC Co., Ltd.
  • CRScube Inc.
  • DOT INTERNATIONAL Co. Ltd.
  • ERT Asia Group K.K.
  • Foresight Group Japan K.K.
  • George Clinical
  • Hamamatsu University Hospital
  • INC Research Japan K.K.
  • Information Services International - Dentsu, Ltd.
  • ITOCHU Techno-Solutions Corporation
  • Japan Medical Data Center Co., Ltd.
  • Keio University Faculty of Pharmacy
  • LSI Medience Corporation
  • LSK Global Pharma Services Co., Ltd.
  • Medical Services Network Co., Ltd.
  • Medidata Solutions K. K.

Registration Fees 

Other Fees

Student
¥5000.00

Member

Charitable Nonprofit/Academia Member
¥19000.00
Member Government
¥29000.00
Member Standard
¥84000.00

Non-Member

Charitable Nonprofit/Academia Nonmember
¥19000.00
NonMember Government
¥44000.00
NonMember Standard
¥99000.00
Registration Fees for Additional Offerings
#1 Basic Introduction for Non-Specialist: Drug-Drug Interaction and Summary of Change in New Japanese Drug-Drug Interaction Guidelin - Charitable Nonprofit/Academia Member Rate
¥2500.00
#1 Basic Introduction for Non-Specialist: Drug-Drug Interaction and Summary of Change in New Japanese Drug-Drug Interaction Guidelin - Charitable Nonprofit/Academia Nonmember Rate
¥2500.00
#1 Basic Introduction for Non-Specialist: Drug-Drug Interaction and Summary of Change in New Japanese Drug-Drug Interaction Guidelin - Member Government Rate
¥5000.00
#1 Basic Introduction for Non-Specialist: Drug-Drug Interaction and Summary of Change in New Japanese Drug-Drug Interaction Guidelin - Member Standard Rate
¥12000.00
#1 Basic Introduction for Non-Specialist: Drug-Drug Interaction and Summary of Change in New Japanese Drug-Drug Interaction Guidelin - NonMember Government Rate
¥5000.00
#1 Basic Introduction for Non-Specialist: Drug-Drug Interaction and Summary of Change in New Japanese Drug-Drug Interaction Guidelin - NonMember Standard Rate
¥12000.00
#2 Next Steps for Content of Company Core Data Sheet Prepared by Western Companies - Part 1 - Charitable Nonprofit/Academia Member Rate
¥2500.00
#2 Next Steps for Content of Company Core Data Sheet Prepared by Western Companies - Part 1 - Charitable Nonprofit/Academia Nonmember Rate
¥2500.00
#2 Next Steps for Content of Company Core Data Sheet Prepared by Western Companies - Part 1 - Member Government Rate
¥5000.00
#2 Next Steps for Content of Company Core Data Sheet Prepared by Western Companies - Part 1 - Member Standard Rate
¥12000.00
#2 Next Steps for Content of Company Core Data Sheet Prepared by Western Companies - Part 1 - NonMember Government Rate
¥5000.00
#2 Next Steps for Content of Company Core Data Sheet Prepared by Western Companies - Part 1 - NonMember Standard Rate
¥12000.00
#3 Action Learning for Six Sigma Analytical Tools Using Real Case Studies - Charitable Nonprofit/Academia Member Rate
¥2500.00
#3 Action Learning for Six Sigma Analytical Tools Using Real Case Studies - Charitable Nonprofit/Academia Nonmember Rate
¥2500.00
#3 Action Learning for Six Sigma Analytical Tools Using Real Case Studies - Member Government Rate
¥5000.00
#3 Action Learning for Six Sigma Analytical Tools Using Real Case Studies - Member Standard Rate
¥12000.00
#3 Action Learning for Six Sigma Analytical Tools Using Real Case Studies - NonMember Government Rate
¥5000.00
#3 Action Learning for Six Sigma Analytical Tools Using Real Case Studies - NonMember Standard Rate
¥12000.00
#4 Coaching as a Diverse Communication Tool Across Functions and Areas - Charitable Nonprofit/Academia Member Rate
¥2500.00
#4 Coaching as a Diverse Communication Tool Across Functions and Areas - Charitable Nonprofit/Academia Nonmember Rate
¥2500.00
#4 Coaching as a Diverse Communication Tool Across Functions and Areas - Member Government Rate
¥5000.00
#4 Coaching as a Diverse Communication Tool Across Functions and Areas - Member Standard Rate
¥12000.00
#4 Coaching as a Diverse Communication Tool Across Functions and Areas - NonMember Government Rate
¥5000.00
#4 Coaching as a Diverse Communication Tool Across Functions and Areas - NonMember Standard Rate
¥12000.00
#5 The Basics of “Investigator Initiated Trial (IIT)” Regulation - Charitable Nonprofit/Academia Member Rate
¥2500.00
#5 The Basics of “Investigator Initiated Trial (IIT)” Regulation - Charitable Nonprofit/Academia Nonmember Rate
¥2500.00
#5 The Basics of “Investigator Initiated Trial (IIT)” Regulation - Member Government Rate
¥5000.00
#5 The Basics of “Investigator Initiated Trial (IIT)” Regulation - Member Standard Rate
¥12000.00
#5 The Basics of “Investigator Initiated Trial (IIT)” Regulation - NonMember Government Rate
¥5000.00
#5 The Basics of “Investigator Initiated Trial (IIT)” Regulation - NonMember Standard Rate
¥12000.00
#6 Prediction for Human Pharmacokinetics and Safety Using Systems Pharmacology - Charitable Nonprofit/Academia Member Rate
¥2500.00
#6 Prediction for Human Pharmacokinetics and Safety Using Systems Pharmacology - Charitable Nonprofit/Academia Nonmember Rate
¥2500.00
#6 Prediction for Human Pharmacokinetics and Safety Using Systems Pharmacology - Member Government Rate
¥5000.00
#6 Prediction for Human Pharmacokinetics and Safety Using Systems Pharmacology - Member Standard Rate
¥12000.00
#6 Prediction for Human Pharmacokinetics and Safety Using Systems Pharmacology - NonMember Government Rate
¥5000.00
#6 Prediction for Human Pharmacokinetics and Safety Using Systems Pharmacology - NonMember Standard Rate
¥12000.00
#7 Next Steps for Content of Company Core Data Sheet Prepared by Western Companies - Part 2 - Charitable Nonprofit/Academia Member Rate
¥2500.00
#7 Next Steps for Content of Company Core Data Sheet Prepared by Western Companies - Part 2 - Charitable Nonprofit/Academia Nonmember Rate
¥2500.00
#7 Next Steps for Content of Company Core Data Sheet Prepared by Western Companies - Part 2 - Member Government Rate
¥5000.00
#7 Next Steps for Content of Company Core Data Sheet Prepared by Western Companies - Part 2 - Member Standard Rate
¥12000.00
#7 Next Steps for Content of Company Core Data Sheet Prepared by Western Companies - Part 2 - NonMember Government Rate
¥5000.00
#7 Next Steps for Content of Company Core Data Sheet Prepared by Western Companies - Part 2 - NonMember Standard Rate
¥12000.00
#8 An Introduction to Adaptive Designs - Charitable Nonprofit/Academia Member Rate
¥2500.00
#8 An Introduction to Adaptive Designs - Charitable Nonprofit/Academia Nonmember Rate
¥2500.00
#8 An Introduction to Adaptive Designs - Member Government Rate
¥5000.00
#8 An Introduction to Adaptive Designs - Member Standard Rate
¥12000.00
#8 An Introduction to Adaptive Designs - NonMember Government Rate
¥5000.00
#8 An Introduction to Adaptive Designs - NonMember Standard Rate
¥12000.00
#9 Let’s Learn and Talk about Project Management Basics of the Clinical Study in Medical Institutes! - Charitable Nonprofit/Academia Member Rate
¥2500.00
#9 Let’s Learn and Talk about Project Management Basics of the Clinical Study in Medical Institutes! - Charitable Nonprofit/Academia Nonmember Rate
¥2500.00
#9 Let’s Learn and Talk about Project Management Basics of the Clinical Study in Medical Institutes! - Member Government Rate
¥5000.00
#9 Let’s Learn and Talk about Project Management Basics of the Clinical Study in Medical Institutes! - Member Standard Rate
¥12000.00
#9 Let’s Learn and Talk about Project Management Basics of the Clinical Study in Medical Institutes! - NonMember Government Rate
¥5000.00
#9 Let’s Learn and Talk about Project Management Basics of the Clinical Study in Medical Institutes! - NonMember Standard Rate
¥12000.00
#10 HTA 2016? What are the challenges for Japan? - Charitable Nonprofit/Academia Nonmember Rate
¥2500.00
#10 HTA 2016? What are the challenges for Japan? - Member Academia Rate
¥2500.00
#10 HTA 2016? What are the challenges for Japan? - Member Government Rate
¥5000.00
#10 HTA 2016? What are the challenges for Japan? - Member Standard Rate
¥12000.00
#10 HTA 2016? What are the challenges for Japan? - NonMember Government Rate
¥5000.00
#10 HTA 2016? What are the challenges for Japan? - NonMember Standard Rate
¥12000.00
Registration Information

To apply discounts for tutorial(s) with full program, please send the application forms (both program and tutorials) to the DIA Japan Office via fax or e-mail. 

Group Discounts

There are no group discounts for this event.

Register Online
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