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11th Annual Meeting DIA Japan 2014
- — #1 Basic Introduction for Non-Specialist: Drug-Drug Interaction and Summary of Change in New Japanese Drug-Drug Interaction Guideline
- — #2 Next Steps for Content of Company Core Data Sheet Prepared by Western Companies - Part 1
- — #3 Action Learning for Six Sigma Analytical Tools Using Real Case Studies
- — #4 Coaching as a Diverse Communication Tool Across Functions and Areas
- — #5 The Basics of “Investigator Initiated Trial (IIT)” Regulation
- — Student Session
- — #10 HTA 2016? What are the challenges for Japan?
- — #6 Prediction for Human Pharmacokinetics and Safety Using Systems Pharmacology
- — #7 Next Steps for Content of Company Core Data Sheet Prepared by Western Companies - Part 2
- — #8 An Introduction to Adaptive Designs
- — #9 Let’s Learn and Talk about Project Management Basics of the Clinical Study in Medical Institutes!
- — Welcome, Opening Remarks, Global DIA Awards Presentation, and Program Instructions
- — Keynote Speech 1
- — Keynote Speech 2
- — Special Session: Opening Plenary
- — [V1-S1] Vision for the Future: Global Simultaneous Filing to the World First Approval - Strategies for Early NDA Approval
- — [V2-S1] Listen to What the Patient Has to Say - A Message from Patients to Those Engaged in Drug Development
- — [V3-S1] The Dawn of Advanced Regulatory Review and Consultation
- — [V4-S1] Points to Consider on the Biosimilar Development - Comparability Evaluation, Interchangeability, Advantage of Biosimilar Development
- — [V5-S1] Leading Innovation with Stakeholders — the Project Meeting Management
- — [V6-S1] Made in Academia: Seed Development Initiatives
- — [V1-S2] Vision for the Future: Global Simultaneous Approval — Efforts and Challenge for Simultaneous Review on Each Country
- — [V2-S2] Discussion About the Provision of Information for Patients —What is a Patient-Oriented Information from the Regulatory Agencies, Pharmaceutical Companies, and AMedical Professionals?
- — [V3-S2] Medical Big Data Usage — Hopes and Challenges in Clinical Development and Postmarketing Safety Surveillance
- — [V4-S2] Bridging the Gap between Bio-ventures and the Pharmaceutical Industry to Form Drug-Making Partnerships
- — [V5-S2] Magic Bullets for Conflicts!! – Case Study of Conflict Prevention and Resolution in R&D Projects
- — [V6-S2] ARO Activities to Facilitate Late-Phase Clinical Trials in Asia
- — [V1-S3] Global Contribution for Clinical Development from Japan
- — [V2-S3] How Can We Apply the Electric Health Records for Postmarketing Drug Safety in Japan?
- — [V3-S3] Lessons Learned of Adaptive Design from Case Example
- — [V4-S3] Innovation in Development of Orphan Drugs (1) — Status Quo of Designation Scheme and Academia
- — [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
- — [V6-S3] Management of COI in Clinical Trials and Future Perspective
- — [V1-S4] Virtual Meeting of PMDA’s Scientific Consultation: Points to Maximize an Efficiency of the Meeting
- — [V2-S4] What is the Benefit-risk Balance Assessment which Japan is Aiming for? - Strategy for Generation of Useful Information which Contributes to Patients
- — [V3-S4] Innovation of Clinical Development with Maximum Use of Existing Data
- — [V4-S4] Innovation in Development of Orphan Drugs (2) — Diversifying Type of Operation and Companies
- — [V5-S4] Introduction to the Role of Medical Affairs for Research and Development Department
- — [V6-S4] Application of Lean Six Sigma in DM Process Improvement in an Investigator Initiated Clinical Trial
- — Let’s Chat! – Presented by DIA Community
- — [V1-S5] Commercialization of Regenerative Medical Products and Quality Assurance
- — [V2-S5] Is the Risk Management Plan Really Effective? Part I
- — [V3-S5] Multi-Regional Clinical Trials: Where Should it Be Headed?
- — [V4-S5] Fostering Superior Talents involved in Drug Development and Evaluation - The Necessity of “Human Resource Development” and “People-to-people Exchange” beyond Boundaries
- — [V5-S5] Risk-based Approach to Monitoring — Part 1: Current Status and Outlook
- — [V6-S5] Genomic Sampling Over Generations
- — [V1-S6] Expectation and Challenge for Regenerative Medical Products Development - What is Changed Based on the Revision of Pharmaceutical Affairs Law?
- — [V2-S6] Is the Risk Management Plan Really Effective? Part II
- — [V3-S6] Beyond Japan: From Asian Studies to Global Studies
- — [V4-S6] Seeking for the Future Prosperity for Both Pharmaceutical Company and CRO
- — [V5-S6] Risk-based Approachto Monitoring — Part 2: Implementation Status of TransCelerate Member Companies in Japan
- — [V6-S6] New Relationship of Drugs and Medical Devices Will Open up the Future of the Health Care
- — Special Session: Medical Contributions With A New Perspective That Transcends Boundaries
- — Best Presenter/Student Award
- — PMDA Town Hall
- — Round Table: What are Expectations for “Adaptive Licensing"?
- — Closing Remarks