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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 

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 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!”

  • 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.

  • 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

  • 9:00AM - 12:30PM (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.

  • 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.

  • 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.

  • 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.

  • 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.

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:

  • ArisGlobal KK
  • BioClinica Inc.
  • C3i Inc.
  • Capital Medica Co., Ltd.
  • CMIC Co., Ltd.
  • CRScube Inc.
  • DOT INTERNATIONAL Co. Ltd.
  • ERT Asia Group K.K.
  • Foresight Group Japan K.K.
  • Japan Medical Data Center Co., Ltd.
  • LSI Medience Corporation
  • LSK Global Pharma Services Co., Ltd.
  • Medidata Solutions K. K.
  • National Hospital Organization Nagoya Medical Center
  • NDA Group
  • R&G PharmaStudies Co., Ltd.
  • Sleep Well Co., Ltd.
  • Trifecta
  • Veeva Japan K.K.

Registration Fees 

Member

Charitable Nonprofit/Academia Member
¥19000.00
Member Government
¥29000.00
Member Standard
¥79000.00
Member Standard (As of 10/21/2014)
¥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
¥9000.00
#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
¥9000.00
#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
¥9000.00
#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
¥9000.00
#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
¥9000.00
#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
¥9000.00
#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
¥9000.00
#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
¥9000.00
#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
¥9000.00
#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
¥9000.00
#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
¥9000.00
#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
¥9000.00
#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
¥9000.00
#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
¥9000.00
#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
¥9000.00
#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
¥9000.00
#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
¥9000.00
#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
¥9000.00
#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
¥9000.00
#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
¥9000.00
#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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