Agenda

Day 1 Oct 24, 2021

10:00 AM — 11:30 AM

KY00: A New Society and Healthcare Ahead of the Digital Revolution

12:45 PM — 1:45 PM

LS01: New Challenges for Non-Visited Collecting and Providing Information for Proper Use with Digital Transformation (Part 1: Collecting Safety Information)

12:45 PM — 1:45 PM

LS02: Utilization of Asian Clinical Trial Network

12:45 PM — 1:45 PM

LS03: 5 Industry Group Joint Session:New Options in Clinical Trial Operation Model?DCT & Remote Utilization (Part 1)

12:45 PM — 1:45 PM

LS04: Formulation of Development Strategy Documents and the Role of Development Strategy Planners in the Development of Pharmaceutical Products

2:00 PM — 3:00 PM

LS05: New Challenges for Non-Visited Collecting and Providing Information for Proper Use with Digital Transformation (Part 2: Providing Information for Proper Use)

2:00 PM — 3:00 PM

LS06: Dive into Asia!- Asian Collaboration in Clinical Trials

2:00 PM — 3:00 PM

LS07: 5 Industry Group Joint Session:New Options in Clinical Trial Operation Model? DCT & Remote Utilization (Part 2)

2:00 PM — 3:00 PM

LS08: How is Your Preparation for the New Challenges, Young Guys

3:30 PM — 4:30 PM

LS09: Practical Risk-based Approach to Data Integrity in Decentralized Clinical Trials

3:30 PM — 4:30 PM

LS10: Digital Transformation of Drug Information -For Utilization in All Japan

3:30 PM — 4:30 PM

LS11: Future Vision for Database Use

3:30 PM — 6:45 PM

ST00: Current Status of Clinical Development for Depression. -Issues, Lesson Learns, Solutions-

4:45 PM — 5:45 PM

LS12: How should We Collaborate Together to Enhance Model-Informed Drug Development?

4:45 PM — 5:45 PM

LS13: Let's Think Together about Patient Engagement from the Research Stage of Drug Discovery

4:45 PM — 6:45 PM

SS01: Utilization of Registry Data for Regulatory Application - Implementation as External Control Arm, Post-Marketing Efficacy Assessment -

5:45 PM — 6:45 PM

OS01: Big expectation for International Harmonization by ICH Q12 Implementation

5:45 PM — 6:45 PM

OS02: For Medical Affairs activities based on Patient Centricity

Day 2 Oct 25, 2021

9:00 AM — 10:00 AM

LS14: Global Oncology Development - Aiming to Be A Game Changer

9:00 AM — 10:00 AM

LS15: Transformation of Regulatory interaction: Challenge by Accumulus Synergy

9:00 AM — 10:00 AM

LS16: Toward Informed Consent Form (ICF) Common Template

9:00 AM — 10:00 AM

LS17: Learning from COVID Experience: "Value created from Dialogue" and Talking about Drug Development Program Management

10:15 AM — 11:15 AM

LS18: Guiding RWE Utilization for Regulatory Decision Making in US, EU and Japan

10:15 AM — 11:15 AM

LS19: Valued Globalization under Healthcare New Era with Complexity and Unceratinty

10:15 AM — 11:15 AM

LS20: MPS Development in Japan and Efforts toward Regulatory Acceptance

10:15 AM — 11:45 AM

SS02: Preparations for Unexpected Infections from the COVID- 19 Pandemic:Rapid Development and Supply of Vaccines and Drugs for Patients

1:00 PM — 2:00 PM

LS21: Consider Information Provision from the Patient's Perspective (1) Information Provision with a View to Health Literacy

1:00 PM — 2:00 PM

LS22: Ways to Reduce Hurdles for Clinical Trial Participation by Conducting Good Participatory Practice Workshop Part 1

1:00 PM — 2:00 PM

LS23: Increased Value to Patients and Healthcare Communities with Digital Therapeutics (DTx)

1:00 PM — 2:00 PM

LS24: For Successful Launch of ICH M11: Current Situation and Looking Forward of Content Management for Electronically Structured Clinical Documents

2:15 PM — 3:15 PM

LS25: East Asia Townhall

2:15 PM — 3:15 PM

LS26: Ways to Reduce Hurdles for Clinical Trial Participation by Conducting Good Participatory Practice Workshop Part 2

2:15 PM — 3:15 PM

LS27: Consider Information Provision from the Patient's Perspective (2) Information Provision with a View to Patient Journey

2:15 PM — 3:15 PM

LS28: Issues in Handling of Cartagena Type 1 Use Regulations for Simultaneous International Development of Gene Therapy Drugs

3:45 PM — 4:45 PM

LS29: Capacity Building in Asia

3:45 PM — 4:45 PM

LS30: Paradigm Shift of Clinical Trial Site Costs ~Effort to Address the Diversifying Changes in Clinical Trial Design~

3:45 PM — 4:45 PM

LS31: New System of Clinical Notification for Complexed Clinical Trials

3:45 PM — 4:45 PM

LS32: Innovative e-labeling Initiatives in the World and Discussion on Next Steps for e-labeling in Japan

5:00 PM — 6:30 PM

DA01: Current and Future Status of Drug Development in Japan, the US, and Europe under COVID-19 Pandemic

5:00 PM — 6:00 PM

LS33: Win-Win Collaboration between Industries and Academia: Preparing SOP (Tentative)

5:00 PM — 6:00 PM

OS03: Expedited Approval Systems to Accelerate Patient Access to Innovative Drugs in Japan and the US

5:00 PM — 6:00 PM

OS04: Cross Industorial Human Resource Development for Innovators and Influencers

Day 3 Oct 26, 2021

9:00 AM — 10:00 AM

LS34: Impact of COVID-19 on US Clinical Studies Conducted by Japan-Based Pharmaceutical Companies

9:00 AM — 10:00 AM

LS35: The Application of Computer Simulation to Medical Device: The Outcome of PMDA Science Board in the Fifth Term

9:00 AM — 10:00 AM

LS36: Patient Engagement - Recent Practices and Future Enhancement in Japan

9:00 AM — 10:00 AM

LS37: Paradigm Shift towards Electronic Package Insert -Current Status and Issues after the Revision of the Pharmaceutical Affairs Law-

10:15 AM — 11:45 AM

DA02: Current and Future Status of Drug Development in Japan, the US, and Europe under COVID-19 Pandemic

10:15 AM — 11:15 AM

LS38: Initiatives of Intelligent Automation Process in PV Activities Overview and Opportunities in the Future

10:15 AM — 11:15 AM

LS39: Utilization method of electronic data submitted for J-NDA filing

10:15 AM — 11:15 AM

LS40: Can the Reliability of Clinical Trials be Assured Remotely?

1:00 PM — 2:00 PM

LS41: Data Distribution: Feasibility of EHR Data Interoperatiliby with EDC/CDMS

1:00 PM — 2:00 PM

LS42: Data Visualization; New Innovative Solution in Drug Development

1:00 PM — 2:00 PM

LS43: Experience of Implementation of De-Centralized Clinical Trial in Japan

1:00 PM — 2:00 PM

LS44: FutureEexpectation on Information Delivery of Parmaceuticals and the Challenges: Lessons Learned at COVID-19 Vaccine

2:15 PM — 3:15 PM

LS45: Risk-Based Quality Management (RBQM) in the E8 (R1) Era

2:15 PM — 3:15 PM

LS46: Expectations and Challenges in Clinical Trials Incorporating Telemedicine from the Perspective of Clinical Trial Site and Patient

2:15 PM — 3:15 PM

LS47: Make the Unexpected within the Expected! Can Your Organization Act without Hassle in the Event of an Unexpected Crisis?

2:15 PM — 3:15 PM

LS48: Our New Challenges and New Solutions - Discuss Our Hot Topics for Our Future-

3:45 PM — 5:15 PM

DA03: PMDA Town Hall

3:45 PM — 4:45 PM

LS49: Change the Unexpected into the Expected ! Will Your Team Progress without Panic When a Crisis Occurs?

3:45 PM — 4:45 PM

LS50: Transformation and Innovation in Drug Development with Environmental Changes Induced by COVID-19

3:45 PM — 4:45 PM

OS05: Embracing Digital Opportunities to Engage Publication Readers including Patients

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18th DIA Japan Annual Meeting 2021

Agenda

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