アジェンダ

Day 1 2018年6月24日 (日)

8:30 AM — 12:00 PM

#20: Real World Evidence Studies to Evaluate the Safety and Effectiveness of Therapeutic Interventions – Is the Data Fit for Purpose and How Will You Know?

8:30 AM — 12:00 PM

#21: The IDMP Challenge: Points to Consider for Pharmacovigilance Departments

8:30 AM — 12:00 PM

#22: Protocol Co-Design with Patients and Advocates

8:30 AM — 12:00 PM

#23: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development Lifecycle

8:30 AM — 12:00 PM

#24: Preparing for a US FDA Advisory Committee Meeting

8:30 AM — 12:00 PM

#25: Precedent: A Driver of Regulatory Strategy

8:30 AM — 12:00 PM

#27: The Evolving Role of Payers in Drug Development: Pricing, Pharmacoeconomics, and Health Technology Assessment

8:30 AM — 12:00 PM

#28: Preparing Documents for Disclosure and Public Sharing

8:30 AM — 12:00 PM

#29: Leadership: How to Organize and Lead People in a Work Group

9:00 AM — 5:00 PM

#40: Smart, Innovative Risk-Based Auditing: Shifting the Paradigm

9:00 AM — 5:00 PM

#42: Back to the Future: Combination Products in the 21st Century

10:30 AM — 12:00 PM

Emerging Professionals and Student Forum

1:00 PM — 4:30 PM

#30: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model

1:00 PM — 4:30 PM

#31: Machine Learning in Pharmacovigilance

1:00 PM — 4:30 PM

#31: Machine Learning in Pharmacovigilance

1:00 PM — 4:30 PM

#33: Quality Tolerance Limits/Issue Management: Taming the Beast of Clinical Development Risk

1:00 PM — 4:30 PM

#34: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development

1:00 PM — 4:30 PM

#35: FDA Advisory Committee Purpose and Noninferiority Case Study: Rivaroxaban

1:00 PM — 4:30 PM

#36: Value Pricing Bootcamp: A Crash Course in How to Use Real World Evidence to Better Measure Outcomes and Evaluate New Innovative Therapies

1:00 PM — 4:30 PM

#37: Data Visualization in the Life Sciences

3:00 PM — 4:00 PM

Effective Use of Social Media

4:15 PM — 5:30 PM

The Power of Networking

Day 2 2018年6月25日 (月)

8:30 AM — 10:00 AM

Opening Plenary Session and Keynote Speaker

10:15 AM — 10:45 AM

Deloitte Innovation Theater: Engage. Innovate. Execute. - How Digital Technologies are Transforming Clinical Development

10:15 AM — 11:00 AM

Networking Do's and Don'ts

10:15 AM — 10:45 AM

PAREXEL International Innovation Theater: Innovation’s Greater Purpose - How Technology Can Increase Commercial Success

10:30 AM — 11:00 AM

LinkedIn Review

11:00 AM — 12:15 PM

‘Target’ing Pediatric Oncology Development: New Global Pediatric Considerations Under FDARA 2017

11:00 AM — 12:15 PM

A Hot Debate: Perspectives on Benefit and Risk From Patients Across Diseases

11:00 AM — 12:30 PM

Analyzing Innovations Progress in the Gottlieb Era

11:00 AM — 12:00 PM

Beyond Robotics Process Automation: Next Generation Integrated QMS for R&D

11:00 AM — 12:00 PM

Cardiac Safety in Drug Development and the Critical Role of Public-Private Partnerships: The Cardiac Safety Research Consortium Model

11:00 AM — 12:00 PM

Contracting for Value: From Outcomes-Based Contracts to Bundled Payment Programs: What’s Working and Why

11:00 AM — 12:15 PM

Culture: The Link Between Team Culture and Productivity - An Interactive Workshop

11:00 AM — 12:00 PM

Data Integrity Playbook: A Cross-Functional, Risk-Based, Analytics-Driven Approach to Monitor Data Integrity

11:00 AM — 12:15 PM

FDA Innovation in Pharmaceutical Quality Assessment and Inspection

11:00 AM — 12:00 PM

From Patients and Advocacy Groups to Operations and Beyond: Obtaining and Incorporating Input from Stakeholders in Protocol Design

11:00 AM — 12:15 PM

How Can We Optimally Incorporate Real World Evidence into Regulatory Decision-Making?

11:00 AM — 12:15 PM

Patient-Focused Medicines Development: Where It has Led Us to Today, What Challenges Remain, and What Do We Still Need to Do to Achieve Success?

11:00 AM — 12:00 PM

Regenerative Medicine Advanced Therapies: Facilitating Product Development and Approval

11:00 AM — 12:15 PM

Scientific Communication Key Message Development, Management, and Dissemination

11:00 AM — 12:15 PM

Signal Management: Separating Needles From Haystacks

11:00 AM — 12:00 PM

The Metamorphosis of Clinical Trials: Evolving Roles of Stakeholders in Digital Trials

11:00 AM — 12:15 PM

The Who, What, How, When, and Why of Using Mobile Technology in Clinical Trials

11:00 AM — 12:30 PM

Unmet Medical Need: Diversity of Definitions and Viewpoints – Detangling the Challenge

11:00 AM — 12:15 PM

Use of Historical Information in Clinical Trial Design

11:00 AM — 12:15 PM

Using Fast Healthcare Interoperability Resources (FHIR®) for Clinical Research

12:30 PM — 1:00 PM

EU Global Data Protection Regulation and Impact on US Companies

12:30 PM — 1:30 PM

Organizational Change and Knowledge Management for Cybersecurity Threats

12:45 PM — 1:15 PM

IQVIA Innovation Theater: Re-imagine Clinical Development with Human Data Science

12:45 PM — 1:15 PM

PPD Innovation Theater: Reimagining Study Planning and Feasibility to Create More Efficient Clinical Trials

1:15 PM — 1:45 PM

Using Quality-Inspired Dashboards to Track Patient Engagement

1:30 PM — 2:00 PM

Covance Innovation Theater: Evidence-Based Approaches to Accelerating Patient Recruitment and Improving Patient Retention

1:30 PM — 2:00 PM

PAREXEL International Innovation Theater: The Innovation Imperative: The Future of Drug Development

1:45 PM — 2:45 PM

DIA Good Clinical Practices and QA Community Round Table Discussion: Data Integrity Playbook: A Cross-Functional, Risk-Based, Analytics-Driven Approach to Monitor Data Integrity

1:45 PM — 2:45 PM

DIA Medical Writing Community Round Table Discussion: Scientific Communication Key Message Development, Management, and Dissemination

1:45 PM — 2:45 PM

New Approaches, Novel Endpoints, and Next-Generation Trials

2:00 PM — 2:30 PM

Drug Safety: A Continuum Approach Linking Pre-Market and Post-Market Safety Assessment

2:00 PM — 2:30 PM

On the Soapbox: Right to Try

2:15 PM — 2:45 PM

DiagnoSearch Life Sciences Innovation Theater: Disruptive Innovation - ‘Wide-Angle-Data’ - Intuitive Algorithms and Artificial Intelligence for Real-Time Safety and Risk Management

2:15 PM — 2:45 PM

SAS Institute Innovation Theater: Real World Evidence - Better, Faster, More!

3:00 PM — 4:15 PM

A New Ecosystem: The Nature of Relationships Between Patient Advocacy Groups and Sponsors

3:00 PM — 4:15 PM

A Quality-by-Design Approach to Trial Design and Conduct: Case Studies from the Clinical Trials Transformation Initiative

3:00 PM — 4:15 PM

Applying Artificial Intelligence, Machine Language, Natural Language Processing, and Predictive Models in Clinical Trials to Deliver Value to Stakeholders

3:00 PM — 4:15 PM

Bayesian Application in Small-Sized Clinical Trials

3:00 PM — 4:15 PM

Courageous Leadership

3:00 PM — 4:15 PM

Development of Microbiome-Derived Therapeutics

3:00 PM — 4:00 PM

eSource: The Road to Real World Evidence – Are We There Yet?

3:00 PM — 4:00 PM

Essential Project Leadership in Navigating an Evolving Regulatory Landscape in Asia-Pacific

3:00 PM — 4:00 PM

Facilitating Nonclinical Data-Sharing and Access Across the Industry

3:00 PM — 4:00 PM

FDA Expectations for Demonstration of Interchangeability

3:00 PM — 4:15 PM

How Inspection-Ready is Your Organization?

3:00 PM — 4:30 PM

International Regulatory Convergence

3:00 PM — 4:15 PM

Mobile Accelerometry in Clinical Trials: Potential Applications and Meaningful Outcomes

3:00 PM — 4:15 PM

New Technologies in Pharmaceuticals and Biopharmaceuticals: Opportunities and Regulatory Challenges

3:00 PM — 4:15 PM

Novel Approaches to Pharmacovigilance Collaboration

3:00 PM — 4:15 PM

Real World Evidence for Value and Access

3:00 PM — 4:15 PM

TFDA Town Hall

3:00 PM — 4:15 PM

The Evolving Biosimilars Landscape: A Medical Affairs Perspective

3:00 PM — 4:15 PM

Using Real World Evidence for Regulatory Support: Time to Embrace the Future

4:45 PM — 5:15 PM

Advanced Clinical Innovation Theater: Preparing for the Next Generation of Clinical Research

4:45 PM — 5:15 PM

ArisGlobal Innovation Theater: A Clinical Perspective - How Cognitive E-2-E Pharma Platforms can Transform Productivity in Pharma - Introducing LifeSphere from Clinical to Regulatory

5:30 PM — 6:00 PM

Appian Innovation Theater: Moving beyond Cloud with Digital Transformation to Unify Process, Connect Data, and Turbocharge Innovation

5:30 PM — 6:00 PM

Cognizant Innovation Theater - Powering New Possibilities for Site-Sponsor Collaboration with the Shared Investigator Platform in partnership with TransCelerate

Day 3 2018年6月26日 (火)

8:00 AM — 9:15 AM

2018 Policy Mash-Up: New Shifts in the Healthcare Market and What They May Mean for Patients and the Biopharma Industry

8:00 AM — 9:15 AM

Artificial Intelligence: The Future of Regulatory Affairs

8:00 AM — 9:15 AM

Best Practices for Implementing Lay Summaries and Communicating Results to Patients

8:00 AM — 9:15 AM

Building Your Brand

8:00 AM — 9:15 AM

CMC Challenges for Breakthrough Therapies and Other Worldwide Accelerated Approval Programs

8:00 AM — 9:15 AM

Early HTA Scientific Advice: Does it Improve Internal Company Decision-Making and Ensure Predictability of HTA Outcome?

8:00 AM — 9:15 AM

Effective Management of Internal Stakeholders and External Strategic Partners from Multiple Perspectives: Non-Profit, CRO, and Pharmaceutical Industry

8:00 AM — 9:15 AM

FDA Data Standards Update

8:00 AM — 9:15 AM

Generic Drug Products: Comparison of Safety Profile With Branded Cousin

8:00 AM — 9:15 AM

Global Regulatory Strategies for Biosimilars

8:00 AM — 9:15 AM

Incorporating Patient Input Into US Food and Drug Administration’s Medical Product Development and Regulatory Decision Making

8:00 AM — 9:00 AM

Novel Approaches for Accessing the CNS: Nonclinical and Clinical Challenges

8:00 AM — 9:00 AM

Oversight in the Era of E6 (R2)

8:00 AM — 9:15 AM

Pediatric and Rare Disease Drug Development

8:00 AM — 9:00 AM

Quantifying the Impact of Credentialed Clinical Research Site Professionals on Clinical Trial Conduct Quality

8:00 AM — 9:30 AM

Triple-A RWE: Adequate Data, Appropriate Study Designs, and Actionable Evidence

8:00 AM — 9:15 AM

Update on Collaboration and Trends in Global Companion Diagnostics

8:00 AM — 9:00 AM

Utilizing and Understanding Real World Evidence Solutions to Efficiently Recruit the Most Appropriate Patients and Sites for Clinical Trials

9:15 AM — 9:45 AM

FDA Warning Letters on Data Integrity

9:30 AM — 10:30 AM

Brexit: Practical Real-World Solution Planning

9:30 AM — 10:30 AM

DIA Patient Engagement Community Round Table Discussion: New Ecosystem: The Nature of Relationships Between Patient Advocacy Groups and Sponsors

9:30 AM — 10:30 AM

DIA Regulatory Community Round Table Discussion: Artificial Intelligence: The Future of Regulatory Affairs

9:45 AM — 10:15 AM

Covance Innovation Theater: Case Study - Driving Clinical Transformation Through a Next-Generation of Data Integration and Analytic Technologies with a GlaxoSmithKline-Covance Partnership

9:45 AM — 10:15 AM

On the Soapbox: Blockchain and Genomics

9:45 AM — 10:15 AM

Veeva Systems Innovation Theater: Global Industry Report - New Findings from the 2018 Unified Clinical Operations Survey

10:00 AM — 10:30 AM

Building a Dynamic Presentation: Rethinking Audience Engagement

10:30 AM — 11:30 AM

Automation with Intelligence: From Standard-Based Solution to Metadata-Driven Automation

10:30 AM — 11:45 AM

Biosimilars: Demonstrating Structural and Functional Similarity

10:30 AM — 11:45 AM

Common Data Model Harmonization for Evidence Generation

10:30 AM — 11:45 AM

Digital Data and New Technologies to Drive Customer Impact in Medical Affairs, Medical Writing, and Medical Communications

10:30 AM — 11:45 AM

Digital Data Flow from Protocol to Report: TransCelerate’s Common Protocol Template and the Art of the Possible

10:30 AM — 11:30 AM

Executives Respond to the State of the Industry Report on Risk-Based Approaches in Clinical Trials: Opportunity or Threat?

10:30 AM — 11:30 AM

Expanded Access: Where Are We Now?

10:30 AM — 11:45 AM

Generic Drug Town Hall

10:30 AM — 11:30 AM

Global Clinical Trials: Lessons in Effective Execution

10:30 AM — 12:00 PM

Global Perspectives on Patient Engagement

10:30 AM — 11:45 AM

Mobile Reported Outcomes: A Forum on Patient and Caregiver Assessments

10:30 AM — 11:45 AM

Personalized Medicine Approaches During Early-Phase Clinical Research

10:30 AM — 11:45 AM

Regulators’ Utilization of Real-World Data in Pharmacovigilance Activities

10:30 AM — 11:45 AM

The Adventures of Patient Experience in Drug Development

10:30 AM — 11:45 AM

The European Medical Devices Regulation and MDUFA IV: One Year On - Is It Any Clearer?

10:30 AM — 11:45 AM

The Patient's Assessment of the Patient-Focused Drug Development Meeting Initiatives

10:30 AM — 11:45 AM

Time-to-Event Analysis in Clinical Trials

10:30 AM — 12:00 PM

Unmet Medical Need: Can the Stakeholders Align? Progress to Date

12:00 PM — 1:00 PM

Yes, No, Maybe: Sharing Health and Other Data for Research - Enthusiasm and Concern from the Patient Community

12:10 PM — 12:55 PM

AMPLEXOR Innovation Theater: How Regulatory Information Will Become Part of Your Company Big Data Architecture

12:10 PM — 12:55 PM

IQVIA Innovation Theater: Real World Evidence to Enhance Drug Development

1:10 PM — 1:55 PM

BioClinica Innovation Theater: Transformational Trends in Investigator Site Payments 2018

1:10 PM — 1:55 PM

Veeva Systems Innovation Theater: Tufts Research - Strategies from Data Management Leaders to Speed Clinical Trials

1:15 PM — 2:00 PM

Global Evolution in Regulatory Science and Medicine: Novel Modalities and Intersection with Rare Disease Development

1:30 PM — 2:00 PM

Developing Standards to Support the Use of Wearables and Sensors for Objective Data Collection During Clinical Trials

2:00 PM — 3:15 PM

CTD Regulatory Defense Strategies: How Best to Prepare Your Response to Health Authority Queries

2:00 PM — 3:00 PM

Developing and Partnering on Evidence for Outcomes and Value Assessment: Standardizing Measurement for Patient-Centered Care

2:00 PM — 3:00 PM

DIA Regulatory Community Round Table Discussion: Global Regulatory Strategies for Biosimilars

2:00 PM — 3:15 PM

Digitizing a Patient-Focused Clinical Trial Experience

2:00 PM — 3:15 PM

Do the End(point)s Justify the Means? A Peak at Endpoints Accepted by FDA With an Eye Towards Mobile Technology Collection

2:00 PM — 3:30 PM

Future of PharmaTech

2:00 PM — 3:15 PM

Global Development Using Expedited Pathways in Established and Emerging Markets

2:00 PM — 3:15 PM

Globalizing and Regionalizing Medical Information Contact Centers

2:00 PM — 3:15 PM

ICH M9 BCS-Based Biowaivers

2:00 PM — 3:15 PM

Measuring the Impact of Patient Engagement: What to Ask Depends on Who You Ask

2:00 PM — 3:15 PM

Navigating the Regulatory Landscape of Drug-Device Combination Products

2:00 PM — 3:00 PM

Optimizing Clinical Development With Adaptive Trial Designs

2:00 PM — 3:15 PM

Project Management Throwdown: How Not to Get Chopped

2:00 PM — 3:15 PM

Reaching the Underserved: Methods to Ensure Diversity and Inclusion for Patient Research, Clinical Trials, and Advisory Panels

2:00 PM — 3:15 PM

Risk Management: New Directions

2:00 PM — 3:15 PM

Risk-Based Monitoring for Master Protocol Study: A Dilemma and Possible Ways to Go

2:00 PM — 3:15 PM

The Risk Assessment Is Done: Now What? A Guide to Setting Up a Centralized Monitoring Plan

2:00 PM — 3:00 PM

Use of Electronic Health Records (EHRs) as eSource in Clinical Investigations

2:00 PM — 3:15 PM

User-Friendly Tools for Study Planning and Analysis

2:15 PM — 3:15 PM

Avoiding Rejection on your "First Date" with EMA Policy 0070

3:15 PM — 4:15 PM

DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Risk Management - New Directions

3:15 PM — 4:15 PM

DIA Medical Writing Community Round Table Discussion: Digital Data and New Technologies to Drive Customer Impact in Medical Affairs, Medical Writing, and Medical Communications

3:30 PM — 4:00 PM

DIA Insights: Latest Global Healthcare Coverage and How to Get Published

3:30 PM — 4:15 PM

LinkedIn Profile Exchange Review

3:40 PM — 4:10 PM

Veeva Systems Innovation Theater: Simplifying Variation Management

3:40 PM — 4:10 PM

WIRB-Copernicus IRB Group Innovation Theater: Clinical Research Sites: Your Competitive Battleground for Study Success

4:15 PM — 5:30 PM

Building up Efficiencies, Breaking Down Barriers: Using Mobile Technology for Data Capture in Clinical Trials

4:15 PM — 5:30 PM

Challenges and Opportunities in Data Access and Methodology Development for Post-Market Generic Drug Monitoring

4:15 PM — 5:30 PM

Complex Innovative Designs and Model-Informed Drug Development Related: PDUFA VI Pilot Programs

4:15 PM — 5:30 PM

Debunking Decentralized Trials: Sharing Breakthroughs and Deal Breakers

4:15 PM — 5:30 PM

Electronic Submissions Demystified

4:15 PM — 5:30 PM

Evolving Roles and Responsibilities for Medical Affairs Professionals

4:15 PM — 5:30 PM

Future of Endpoints

4:15 PM — 5:30 PM

Gene Therapy: Advances in Translating Technology

4:15 PM — 5:30 PM

ICH Q12: A Paradigm Changing Guidance for Post-Approval Changes?

4:15 PM — 5:15 PM

Is It Time to Change the Content and Format of Labeling?

4:15 PM — 5:15 PM

Medical Monitoring in Non-Interventional Studies: Need for Medical Leadership and Study Primary Care Management

4:15 PM — 5:30 PM

Patient Engagement in Pharmacovigilance

4:15 PM — 5:30 PM

Pharmacovigilance: No Longer Going it Alone

4:15 PM — 5:30 PM

Priority Review Vouchers: Here to Stay and Worth the Effort?

4:15 PM — 5:30 PM

Redefining the Site Investigator's Experience

4:15 PM — 5:15 PM

Sustainable Healthcare Funding

4:15 PM — 5:30 PM

The Letter and Spirit of Risk-Based Monitoring: How to Creatively Implement Risk-Based Modeling and Unlock the Potential of the Team

4:15 PM — 5:15 PM

Using Advocacy Partnerships to Improve Real World Evidence in Clinical Trials

4:15 PM — 5:30 PM

Which Regulatory Project Management Staff at FDA Should You Engage With? When and How?

4:30 PM — 5:30 PM

DIA Devices and Diagnostics Community Round Table Discussion: Navigating the Regulatory Landscape of Drug-Device Combination Products

4:30 PM — 5:30 PM

DIA Medical Writing Community Round Table Discussion: CTD Regulatory Defense Strategies - How Best to Prepare Your Response to Health Authority Queries

Day 4 2018年6月27日 (水)

8:00 AM — 9:15 AM

Automation in Pharmacovigilance: Doing More with Less

8:00 AM — 9:15 AM

Becoming Highly Self-Aware: Leading in the Midst of Ambiguity

8:00 AM — 9:15 AM

Building a Roadmap to the Implementation of the Risk-Based Monitoring Process: Facilitating the Perspectives of All Stakeholders

8:00 AM — 9:15 AM

Can I Implement That Now? Efficiently Managing Post-Approval CMC Changes

8:00 AM — 9:15 AM

Data and Quality Approaches to Informing Global Investigative Site Selection

8:00 AM — 9:00 AM

DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Pharmacovigilance: No Longer Going It Alone

8:00 AM — 9:00 AM

DIA Patient Engagement Community Round Table Discussion: Reaching the Underserved - Methods to Ensure Diversity and Inclusion for Patient Research, Clinical Trials, and Advisory Panels

8:00 AM — 9:15 AM

Evolution and Harmonization of First-in-Human Guidelines

8:00 AM — 9:15 AM

Global Rare Disease Town Hall

8:00 AM — 9:15 AM

Harmonizing Regulatory Science Through the International Council for Harmonisation (ICH)

8:00 AM — 9:15 AM

Harnessing the Power of Data and Analytics to Enhance Quality

8:00 AM — 9:15 AM

How Do Patients and Other Multi-Disciplinary Stakeholders Collaborate to Develop Patient Registries which Accelerate Research?

8:00 AM — 9:15 AM

Maintaining Patient Engagement in the Development of Patient-Reported Outcome (PRO) Measures

8:00 AM — 9:00 AM

Operationalizing Real World Evidence and Value

8:00 AM — 9:15 AM

Opportunities for Efficient and Innovative Study Designs

8:00 AM — 9:15 AM

phactMI: A Collaborative Approach to Advancing the Practice of Medical Information and Enabling Innovative Customer Solutions

8:00 AM — 9:00 AM

PowerUp: Career Transforming Moments

8:00 AM — 9:15 AM

Regulatory and Ethical Considerations with Placebo Administration Using a Central Venous Access Device in a Pediatric Trial

8:00 AM — 9:15 AM

Risk Communication and Patient Safety: Recent Learnings and New Approaches

8:00 AM — 9:30 AM

Value-Based Assessment and Contracting: What Needs to be Done to Make it a Best Practice?

8:00 AM — 9:15 AM

What Can We Say About Combination Products? Labeling, Advertising and Promotion of Combination Products

9:15 AM — 9:45 AM

New Resource from the DIA Interdisciplinary Disclosure Working Group

9:30 AM — 10:30 AM

DIA Clinical Data Management Community Round Table Discussion: The Letter and Spirit of Risk-Based Monitoring - How to Creatively Implement the RBM and Unlock the Potential of the Team

9:30 AM — 10:30 AM

DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Patient Engagement in Pharmacovigilance

9:30 AM — 10:30 AM

Good Things Come in Small Packages: Product Development Strategies for Small Companies

9:45 AM — 10:15 AM

ArisGlobal Innovation Theater: A Regulatory Perspective - How Cognitive E-2-E Pharma Platforms can Transform Productivity in Pharma - Introducing LifeSphere from Clinical to Regulatory

9:45 AM — 10:15 AM

SAS Institute, JMP Division Innovation Theater: RECIST Criteria and Their Impact on Safety and Efficacy Reporting in Oncology Studies

10:00 AM — 10:30 AM

Getting the Questions Right

10:30 AM — 11:45 AM

Addressing the Elephant in the Room: A Hard Look at Metrics, Legal, Payers, and Other Leading Obstacles Facing the Sustainability of Patient Engagement

10:30 AM — 11:45 AM

Artificial Intelligence: Robots Taking Over Clinical Research

10:30 AM — 11:30 AM

Balancing Regulatory, Medical, and Operational Pillars to Get Pediatric Trials Done Globally

10:30 AM — 11:45 AM

Biosimilar Interchangeability: A Global Perspective

10:30 AM — 11:45 AM

Clinical Data: Let’s Get to the Source and Streamline it to the End

10:30 AM — 12:00 PM

Clinical Trial Disclosure: Learnings from EMA Policy 0070, NIH Final Rule, and FDA’s Clinical Data Summary Pilot Program

10:30 AM — 11:45 AM

Collaboration Across the Medical Affairs Ecosystem to Advance Patient Care

10:30 AM — 11:45 AM

Determining Data Integrity: Decoding the Impact of Inspectional Observations

10:30 AM — 11:45 AM

Harmonization Beyond ICH

10:30 AM — 11:45 AM

Innovative Visualization Approaches

10:30 AM — 11:45 AM

New FDA Draft Guidance on Part 11 in Clinical Investigations

10:30 AM — 12:00 PM

Precision Medicine, Gene Editing, and Gene Therapy: Current Status and Regulatory Challenges of Integrating Genetic Medicine into Clinical Care

10:30 AM — 11:45 AM

Rebuilding or Building a Research Site in the Year 2020

10:30 AM — 11:45 AM

Reducing the Burden of Drug Safety Risk Minimization Programs on the Healthcare System: How Do We Do So and What Has Been Learned to Date?

10:30 AM — 11:45 AM

Sex Considerations in the FDA Drug Review Pipeline: The Where, When, and How

10:30 AM — 11:30 AM

Streamlining Vendor Reconciliation

10:30 AM — 12:00 PM

Unmet Medical Need: Path Forward – Creating a Commonly Agreed Criteria Globally

10:30 AM — 11:45 AM

You've Got Data #now what?

12:00 PM — 1:00 PM

Just the Right Tool: ICH E6 (R2) Compliance Tools for Small to Mid-Size Companies

12:00 PM — 12:30 PM

Making Better Portfolio Prioritization Decisions

12:10 PM — 12:55 PM

Salesforce Innovation Theater: Accelerate R&D Innovation with Salesforce for Life Sciences

12:10 PM — 12:55 PM

ZS Associates Innovation Theater: Building an RWE Bridge from Population Health to Personalized Medicine

12:45 PM — 1:15 PM

Moving Forward with the EU Vigil: The Patient Contact in Pharmacovigilance

1:00 PM — 2:00 PM

DIA Clinical Pharmacology Community Round Table Discussion: Evolution and Harmonization of First-in-Human Guidelines

1:00 PM — 2:00 PM

DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Automation in Pharmacovigilance - Doing More With Less

1:10 PM — 1:55 PM

IQVIA Innovation Theater: The Digital Future is Now

1:10 PM — 1:40 PM

PAREXEL International Innovation Theater: The Application of Mobile Health Across the Clinical Development Spectrum: 5 Critical Insights

1:15 PM — 2:00 PM

The Worst Co-Worker on the Block

1:30 PM — 2:00 PM

Difficult Conversations

2:00 PM — 3:00 PM

A New Way of Authoring and Reviewing Documents for Clinical Development

2:00 PM — 3:15 PM

Achieving Customer Centricity to Advance Patient Care Through Innovative Communication Channels

2:00 PM — 3:00 PM

AdPromo: Assessing Risk in the Current Regulatory Environment

2:00 PM — 3:15 PM

Clinical Outcome Assessments (COA) Endpoints for Use in Rare and Ultra-Rare Disease Clinical Trials

2:00 PM — 3:15 PM

Courageous Hiring

2:00 PM — 3:00 PM

Do the Evolution: The Future Role of Clinical Data Management

2:00 PM — 3:15 PM

Engaging the Rare Disease Community to Design Clinical Trials

2:00 PM — 3:15 PM

Expedited E2B Safety Reporting in Interventional Clinical Trials: Convergence of Global Expectations?

2:00 PM — 3:15 PM

Gene Therapy Clinical Trials: Current Challenges

2:00 PM — 3:15 PM

IMEDS: A Collaboration Based on the FDA's Sentinel Initiative

2:00 PM — 3:15 PM

Implementation of eConsent and Other Digital Clinical Trial Innovations

2:00 PM — 3:15 PM

Innovative and Effective Authoring Strategies to Facilitate Accelerated Regulatory Submissions

2:00 PM — 3:15 PM

Modernization and Harmonization of Inspectional Approaches

2:00 PM — 3:15 PM

PMDA Town Hall

2:00 PM — 3:15 PM

Predicting Future Generic Drug Competition: Powering Strategic Planning Using Quantitative Methods and Modeling

2:00 PM — 3:15 PM

Real Life Strategies for Collaborative Stakeholder Management

2:00 PM — 3:15 PM

Statistical Challenges in Assessing Drugs’ Efficacy by Utilizing Biomarker Endpoints

2:00 PM — 3:15 PM

Virtual Audits: Do They Achieve the Objective?

2:00 PM — 3:15 PM

What's New in Health Canada: Updates and New Endeavors

2:15 PM — 2:45 PM

First-In-Human Studies: An Examination of the Evolving Regulatory and Clinical Practices to Ensure Subject Safety

3:00 PM — 4:00 PM

DIA Clinical Trial Disclosure and DIA Medical Communication Communities' Round Table Discussion: Clinical Trial Disclosure: Learnings from EMA Policy 0070, NIH Final Rule, and FDA’s Clinical Data Summary Pilot Program

3:00 PM — 4:00 PM

DIA Devices and Diagnostics Community Round Table Discussion: What Can We Say About Combination Products? Labeling, Advertising and Promotion of Combination Products

3:15 PM — 4:00 PM

Use of New Data Sources and Evidence Types for Regulatory Decision Making in Drug Development

3:25 PM — 3:55 PM

Tata Consulting Services Innovation Theater: TCS' Life Sciences Platforms: Disrupt Clinical Research in a Digital World!

3:30 PM — 4:00 PM

Project Management’s Role in Developing and Securing Governance Approval of a Drug Development Program Strategy

4:00 PM — 5:15 PM

Artificial Intelligence: A Disruptive Journey for Pharmacovigilance

4:00 PM — 5:15 PM

Bring Your Own Device ePRO: Hold the Relish, or No Holds Barred?

4:00 PM — 5:15 PM

Current and Future Perspective on Mutual Recognition, Work Sharing, and Global Regulatory Convergence

4:00 PM — 5:15 PM

Design and Statistical Considerations for Real World Evidence to Support Regulatory Decision Making

4:00 PM — 5:15 PM

Does Sourcing Strategy Matter? Executives Debate the Influence of Outsourcing Model on Clinical Trial Execution

4:00 PM — 5:15 PM

Evolving CDISC Standards and Technologies

4:00 PM — 5:15 PM

FUNdamentals of Project Management

4:00 PM — 5:15 PM

How to De-Risk Alliances for Success

4:00 PM — 5:15 PM

Innovations in Managing Global Clinical Supplies

4:00 PM — 5:15 PM

Patient Observation Versus Patient Engagement: Optimizing Development

4:00 PM — 5:15 PM

PDUFA VI: Improving Transparency and Accountability of Electronic Submission and Data Standards Activities

4:00 PM — 5:15 PM

Safe Use and Prescribing of Opioid Medications: An In-Depth Look at the Strategies and Their Evaluation

4:00 PM — 5:15 PM

Special Population Study Challenges

4:00 PM — 5:00 PM

The Impact of Cell and Gene Therapy on the Payer System

4:00 PM — 5:15 PM

Think Like a Regulator: Evaluating Trial Integrity

4:00 PM — 5:00 PM

Update on BREXIT

4:00 PM — 5:15 PM

Using Patient-Centric Outcomes to Engage Patients in Shared Treatment Decision Making

Day 5 2018年6月28日 (木)

8:00 AM — 9:00 AM

DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Risk Management: Artificial Intelligence - A Disruptive Journey for Pharmacovigilance

8:00 AM — 9:00 AM

DIA Patient Engagement Community Round Table Discussion: Addressing the Elephant in the Room - A Hard Look at Metrics, Legal, Payers, and Other Leading Obstacles Facing the Sustainability of Patient Engagement

8:30 AM — 9:00 AM

General Data Protection Regulation (GDPR): Impact, Self-Assessment, and Practical Solutions for Compliance

9:00 AM — 10:15 AM

Assessing Your Clinical Quality Management System: An In-Depth Look at TransCelerate’s Assessment Tool

9:00 AM — 10:15 AM

Beyond Adult Patients, Untapped Advisors in Clinical Development: Adolescents, Parents, Siblings, and Spouses

9:00 AM — 10:15 AM

Biologics and Biosimilars: Payers, Industry, and Academia Collaborating on Post-Marketing Surveillance

9:00 AM — 10:30 AM

EMA/FDA Question Time

9:00 AM — 10:15 AM

Emerging Best Practices and Challenges in Strategic Drug Development and Design Decision Making

9:00 AM — 10:15 AM

Improving Efficiency and Effectiveness in Data Management of Pediatric, Rare Disease, and Oncology Trials

9:00 AM — 10:00 AM

Innovative Funding Models for Novel Therapeutics

9:00 AM — 10:15 AM

Metrics and Meaning: Evolving Metrics in Generic Drug Application Review and Communications to Improve ANDA Submission Planning and Approvability

9:00 AM — 10:15 AM

Putting Patient Experience First

9:00 AM — 10:15 AM

Regulatory and Industry Perspectives on the Common Protocol Template

9:00 AM — 10:15 AM

The Correlation Between Patient-Reported Outcomes and Clinician-Reported Outcomes

9:00 AM — 10:30 AM

Unmet Medical Need: What Did We Create Together and Where to Take It?

10:45 AM — 12:00 PM

FDA Town Hall

DIA 2018 Global Annual Meeting

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