アジェンダ

Day 1 2019年6月23日 (日)

9:00 AM — 12:30 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?

9:00 AM — 12:30 PM

#21: Basics of European Medical Device Regulation

9:00 AM — 12:30 PM

#22: Protocol Co-Design with Patients and Advocates

9:00 AM — 12:30 PM

#23: Preparing for a US FDA Advisory Committee Meeting

9:00 AM — 12:30 PM

#24: Data Visualization in the Life Sciences

9:00 AM — 12:30 PM

#27: eCOA 101: The What, Why, and How of eCOA to Reduce Barriers to Adoption in Clinical Studies

9:00 AM — 12:30 PM

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

9:00 AM — 5:00 PM

#40: Interdisciplinary Safety Evaluation During Product Development

9:00 AM — 5:00 PM

#41: Toolkit Approach to Best Practices in Root Cause Analysis and CAPA Management Workshop

9:00 AM — 5:00 PM

#42: Patient Preferences: Using Conjoint Analysis and Stated Preferences in Drug Development and Regulatory Decision Making

9:00 AM — 5:00 PM

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

11:00 AM — 12:30 PM

Forum for Students and Emerging Professionals

12:45 PM — 2:00 PM

Student Networking Luncheon

1:30 PM — 5:00 PM

#30: Machine Learning in Pharmacovigilance

1:30 PM — 5:00 PM

#33: European Regulatory Meetings: How Best to Prepare and Perform

1:30 PM — 5:00 PM

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

1:30 PM — 5:00 PM

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

1:30 PM — 5:00 PM

#36: A Novel Interactive Safety Graphic to Evaluate Potential Drug-Induced Hepatotoxicity

1:30 PM — 5:00 PM

#37: Patient Literacy 101: Practical Strategies for Improving Your Patient Materials

2:30 PM — 3:30 PM

Self-Branding for Social Media

3:45 PM — 5:00 PM

Effective Networking: Know Yourself

3:45 PM — 5:00 PM

Student and Young Professional Resume Workshop

Day 2 2019年6月24日 (月)

7:00 AM — 7:45 AM

Annual Meeting Orientation

8:00 AM — 10:00 AM

Opening Plenary, Keynote, and DIAmond Session

10:10 AM — 10:40 AM

Modernizing Data Review in Drug Development with R Shiny

10:10 AM — 10:55 AM

The Female Perspective on the Clinical Trial Patient Experience: A Live Focus Group

10:15 AM — 10:45 AM

Advanced Clinical Innovation Theater: Raising the Bar on Clinical Oversight to Reduce Risk and Ensure Inspection Readiness

10:15 AM — 10:45 AM

ArisGlobal Innovation Theater: Can Blockchain Technology Change Life Sciences?

11:00 AM — 12:00 PM

Addressing Heterogeneity of Real World Evidence in Drug Safety

11:00 AM — 12:00 PM

Artificial Intelligence in Drug Discovery and Development: Emerging Technologies and Applications

11:00 AM — 12:00 PM

Automation with Intelligence: Transformation From Human Resource to Artificial Intelligence in Risk Management

11:00 AM — 12:00 PM

Collecting Better Patient Experience Data: Lessons Learned from Patient Organizations

11:00 AM — 12:00 PM

Emerging Professionals: Making the Most of Your Networking Experience at the DIA Global Annual Meeting

11:00 AM — 12:00 PM

Emerging Technologies in Clinical Research

11:00 AM — 12:00 PM

FDA Payer Communication Guidance, Twenty Years in the Making: Now What?

11:00 AM — 12:00 PM

Harnessing Power of Advanced Technologies for Digital Transformation in Regulatory Affairs

11:00 AM — 12:00 PM

Innovation in Enrollment, Recruitment, and Retention

11:00 AM — 12:00 PM

International Regulatory Convergence

11:00 AM — 12:00 PM

Making Value-Based Contracting Stick

11:00 AM — 12:00 PM

Moving Forward in EU Pharmacovigilance

11:00 AM — 12:00 PM

Patient Perspective Diversity: Taking Cultural Differences in Patient Views Into Consideration in US, EU, and Japan

11:00 AM — 12:00 PM

PhactMI Benchmarking Survey Highlights: How are the Twenty Seven Member Companies Executing on Medical Information Initiatives

11:00 AM — 12:00 PM

Quality Management Post-Quality Management System Implementation In The Wake of ICH E6 (R2)

11:00 AM — 12:00 PM

Statistical Considerations for Trials Using Surrogate Endpoints for Accelerated Approval

11:00 AM — 12:00 PM

When Disaster Strikes: Developing a Proactive Plan to Address Challenges Brought on by Large Scale Natural Disasters

12:15 PM — 1:00 PM

ICH E2B IND Safety Reporting to FDA Adverse Event Reporting System (FAERS)

12:15 PM — 12:45 PM

IQVIA Innovation Theater: When Context is Hard to Come By – The Emerging Value of External Comparators

12:15 PM — 12:45 PM

Leveraging Extra Value from an Intern Program: Non- Traditional Majors Add Unexpected Value

12:15 PM — 12:45 PM

Parexel Innovation Theater: Transforming the Drug Development Journey Through the Patient’s Eyes

12:30 PM — 1:30 PM

Community Meet Up: Discussion on Data Quality, Real-Time Calculated Metrics, Compliance

1:00 PM — 1:30 PM

Separating the Hype from Reality in Pharmacovigilance Automation

1:00 PM — 1:30 PM

Veeva Systems Innovation Theater: Annual Industry Report: Trends, Insights, and Strategies to Improve Study Execution

1:00 PM — 1:30 PM

WIRB-Copernicus Group Innovation Theater: Getting the Most Out of Your Site Selection Strategy

1:15 PM — 2:15 PM

Round Table Discussion: Emerging Technologies in Clinical Research

1:15 PM — 2:00 PM

The Potential Value of Shared Decision Making (SDM) in Clinical Trial Consideration and Participation

1:30 PM — 2:15 PM

On the Soapbox: Designing Babies - Medical, Ethical, and Social Questions

1:45 PM — 2:15 PM

Advancing Trailblazing Research and Development: When to Speed Up, When to Slow Down

1:45 PM — 2:15 PM

Cognizant Innovation Theater: Shared Investigator Platform: Innovating Clinical Trials Feasibility and Study Start Up

1:45 PM — 2:15 PM

SAS Institute Inc Innovation Theater: Smarter Clinical Trial Enrollment with Real World Data and Simulation Analytics

2:15 PM — 3:15 PM

Blockchain in Clinical Trials Demo: Truth or Dare

2:15 PM — 3:15 PM

Communications with Regulators Beyond Formal Meetings

2:15 PM — 3:15 PM

Developing Standard Core Clinical Outcome Assessments and Endpoints: FDA Perspective and Plans

2:15 PM — 3:15 PM

Emerging Technology to Improve Sponsor-Site Interactions

2:15 PM — 3:15 PM

Examining Essential Elements of Vendor Governance and Comparing Perspectives of Large and Emerging Biopharma

2:15 PM — 3:15 PM

Hot Topics in Digital Health: How is FDA’s Approach Evolving, and What Do Industry and Patients Need to Know?

2:15 PM — 3:15 PM

How Storytelling, Images, and Engagement Can Wow Your Audience: Presentations with Punch!

2:15 PM — 3:15 PM

Hype Versus Reality: Artificial Intelligence and Drug Development

2:15 PM — 3:15 PM

Interpretation of New Pharmacovigilance Regulations: Key Insights

2:15 PM — 3:15 PM

Knowledge Management and Information Sharing to Support Business Continuity

2:15 PM — 3:15 PM

Making Data Meaningful: Using Data Visualization to Drive Efficiency in Safety Analysis

2:15 PM — 3:15 PM

Opportunities and Challenges with First-In-Human Multiple Expansion Cohort Designs in Oncology

2:15 PM — 3:15 PM

Ready or Not: Business Continuity Planning

2:15 PM — 3:15 PM

Show Me the Money! Patient and Caregiver Roles and Compensation in Research, Development, and Innovation

2:15 PM — 3:15 PM

TFDA Town Hall: Focus on Regenerative Medicine

2:15 PM — 3:15 PM

Update from Health Canada: The Health Protection Branch

2:15 PM — 3:15 PM

Update on ICH Quality Topics

2:15 PM — 3:15 PM

Use of Real World Data in Clinical Trials: Abstracting Endpoints from Encounters

2:15 PM — 3:15 PM

Using Real World Data to Develop a Safety Monitoring Program and Ensure Pre- and Post-Market Continuity

3:30 PM — 4:30 PM

A Large Academic Medical Center’s Perspective on Using Precision Medicine to Find Patient Disease Subgroups at Scale

3:30 PM — 4:30 PM

Clinical Research in Emerging Regions

3:30 PM — 4:30 PM

Community Meet Up: Forum of Pharmacovigilance Quality Heads

3:30 PM — 4:30 PM

Compliance: The Importance of Periodic Screenings to Ensure Good Inspection Health

3:30 PM — 4:30 PM

Current Initiatives on Patient Involvement in the Medicinal Product Lifecycle: CIOMS XI

3:30 PM — 4:30 PM

Drug Development Tools in a Digital Era

3:30 PM — 4:30 PM

Enhancing Patient-Focused Outcome Assessment in Medical Product Development

3:30 PM — 4:30 PM

How Statistics Can Help Improve Data Quality: ICH E6 R2

3:30 PM — 4:30 PM

Incorporating Systems-Theory and Human Factors into the Investigations of Serious Harm in Clinical Research

3:30 PM — 4:30 PM

Making Early Access for Patients Happen

3:30 PM — 4:30 PM

Making Trials Work for Special Populations

3:30 PM — 4:30 PM

New Communication Channels for Medical Information

3:30 PM — 4:30 PM

Paving the Path for Family-Centered Design: Caregiver Roles in Medical Product Development

3:30 PM — 4:30 PM

Precision Medicines in Clinical Trials: Understanding and Overcoming Barriers to Adoption

3:30 PM — 4:30 PM

Regulating Innovation in Chemistry, Manufacturing, and Controls: Challenges and Opportunities

3:30 PM — 4:30 PM

Strategic Integration: Is Anyone Getting it Right?

3:30 PM — 4:30 PM

Strategic Priorities of the International Coalition of Medicines Regulatory Authorities in an Increasingly Globalized Industry

3:30 PM — 4:30 PM

The Courage of Career Transitions

3:30 PM — 4:30 PM

Understanding the Data Journey In Virtual Trials

3:30 PM — 4:30 PM

Updates on China Regulatory Reform

4:45 PM — 5:15 PM

Appian Innovation Theater: Accelerating the Regulatory Information Management Journey with Intelligent Automation

4:45 PM — 5:15 PM

Deloitte Consulting Innovation Theater: Reimagining Patient Safety

5:15 PM — 6:15 PM

Community Meet Up: Patient Engagement

5:15 PM — 6:00 PM

Data Analytics Use in Quality Processes

5:30 PM — 6:00 PM

Statistics & Data Corporation Innovation Theater: Artificial Intelligence and Machine Learning: Innovations in Clinical Trial Data Automation

5:30 PM — 6:00 PM

Syneos Health Innovation Theater: Dialing In the Optimal FSP Solution

6:00 PM — 7:00 PM

Community Meet Up: Statistics Community Meet and Greet

Day 3 2019年6月25日 (火)

7:30 AM — 8:00 AM

DIAlogue Session 1: Welcome to Day 2 of DIA 2019

7:30 AM — 8:00 AM

Talent Show

8:00 AM — 9:15 AM

Conducting Clinical Trials with GMOs: Strategies to Overcome Regulatory, Operational, and Patient Enrollment Challenges

8:00 AM — 9:15 AM

DISC and RISK: How DISC Profile in Clinical Trial Teams Impact Implementation of Risk-Based Approaches

8:00 AM — 9:15 AM

Driving Enrollment with a Patient-Centric Focus to Artificial Intelligence

8:00 AM — 9:15 AM

eConsent Done Right

8:00 AM — 9:15 AM

Emerging Issues in CRISPR and Gene Editing Symposium

8:00 AM — 9:15 AM

Facilitating Access: Patient Perspectives on a Streamlined Development Approach for Treatments for Severely-Debilitating or Life-Threatening Diseases

8:00 AM — 9:15 AM

Global Pediatric Policy Update: Are You Ready to Implement FDARA Section 504?

8:00 AM — 9:15 AM

Identifying the Reference Listed Drug for ANDA Submission, Overview of FDA’s Orange Book, and Exclusivities for NDAs and ANDAs

8:00 AM — 9:15 AM

Increasing Personal Resilience To Manage Change

8:00 AM — 9:15 AM

Leveraging Artificial Intelligence and Natural Language Processing in Medical Writing

8:00 AM — 9:15 AM

Patient Focus as Part of the Regulatory Affairs DNA: Opportunities and Challenges

8:00 AM — 9:15 AM

Personalized Healthcare and Clinical Outcomes: How Real World Endpoints Can Improve Approval and Access to Medicine?

8:00 AM — 9:15 AM

Pharmacovigilance Reporting and Quality

8:00 AM — 9:15 AM

Protocol Developments of the Future

8:00 AM — 9:15 AM

Quality Considerations for Complex Generics

8:00 AM — 9:15 AM

Real World Data to Real World Evidence

8:00 AM — 9:15 AM

Single Source of Truth, Integrations, or IoT (Internet of Things): Exploring Ways to Improve Connectedness of Clinical Data

8:00 AM — 9:15 AM

To Err is Human: Progress and Challenges in the Prevention of Medication Errors

8:00 AM — 9:15 AM

Translating Academic Research into Product Development: Integrating GXPs into the Process (Part 1 of 4)

8:00 AM — 9:15 AM

Updates and Lessons Learned from Novel Approaches to Pharmacovigilance Collaboration

9:15 AM — 9:45 AM

Getting the Question Right (GTQR) with Interdisciplinary Collaboration

9:30 AM — 10:30 AM

Round Table Discussion: Enhancing Patient-Focused Outcome Assessment in Medical Product Development

9:30 AM — 10:30 AM

Round Table Discussion: Interpretation of New Pharmacovigilance Regulations: Key Insights

9:30 AM — 10:15 AM

The Negotiation Game: Learn What you Never Knew About Negotiation in a Fun, Interactive, Collaborative Game

9:45 AM — 10:15 AM

Covance Innovation Theater: Fixing the Patient Recruitment "Leaky Funnel"

9:45 AM — 10:15 AM

DiagnoSearch Life Sciences Innovation Theater: Disruptive Innovation: ‘Wide-Angle-Data’ – Fully Integrated Platform with Advanced Analytics and Customized Algorithms for Real Time Safety and Risk Management

10:00 AM — 10:30 AM

GCP for Contributing Investigator Versus Conducting Investigator-Initiated Trials in Emerging Regions

10:30 AM — 11:30 AM

An Industry Collaboration on Pharmacovigilance Analytics

10:30 AM — 11:30 AM

Artificial Intelligence Enhanced Data Analytics for Clinical Trials

10:30 AM — 11:30 AM

Assessing Opportunities to Improve Outsourcing Oversight and the Vendor Qualification Assessment Process

10:30 AM — 11:30 AM

Build and Leverage Your Networks to Influence Stakeholders

10:30 AM — 11:30 AM

Creating Clarity: Changes at CDISC to Make Standards Implementation Easier for all Stakeholders

10:30 AM — 11:30 AM

Emerging Safety Challenges in New Oncology Treatments

10:30 AM — 11:30 AM

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

10:30 AM — 11:30 AM

How Employers are Reinventing Healthcare and What it Means for Research Participation and Evidence

10:30 AM — 11:30 AM

Improving Clinical Trial Risk Management: How To Leverage the IRB's Designed Purpose

10:30 AM — 11:30 AM

Our Doors are Open! Pathways and Programs for Patient Stakeholders to Engage with FDA

10:30 AM — 11:30 AM

Outcomes, Endpoints, and Methods Supporting Oncology and Alzheimer Therapies

10:30 AM — 11:30 AM

PMDA Town Hall

10:30 AM — 11:30 AM

Pregnancy, Breastfeeding, Childcare, Oh My! Finding a Balance for New Moms

10:30 AM — 11:30 AM

Quality and Compliance Management in Medical Information/Medical Affairs

10:30 AM — 11:30 AM

Retooling Risk Assessment to Align with ICH-E6(R2) and Connect to Centralized Monitoring and Risk-Based Monitoring

10:30 AM — 11:30 AM

The Future of Combination Products in the EU

10:30 AM — 11:30 AM

The Rare Disease Experience in Clinical Trials

10:30 AM — 11:30 AM

Use of Real World Evidence to Support Regulatory Decision-Making: First-Year Findings From the RCT-DUPLICATE Project

10:30 AM — 11:30 AM

Walking the Talk: Using Home Nursing as a Patient-Centric Service in Clinical Trials - From Multiple Perspectives

10:30 AM — 11:30 AM

Where Quality Meets Safety and Efficacy: A Conversation with CMC Experts

11:40 AM — 12:25 PM

ArisGlobal Innovation Theater: Getting More Value From Your Data Through A Unified Regulatory Platform

11:40 AM — 12:25 PM

Veeva Systems Innovation Theater: Shortening Database Builds by 40-60%

11:45 AM — 12:15 PM

How to Efficiently Implement a Healthcare Compliance Program in Preparation for Your First Product Launch

12:40 PM — 1:25 PM

AMPLEXOR Innovation Theater: The Great Regulatory Catch-up: Lessons From Big Pharma as Medical Device Manufacturers Succumb to New Reporting Rigor

12:40 PM — 1:25 PM

BioClinica Innovation Theater: When EDC is not Enough: Automating Multi-Country Data Collection and Complex Workflows

1:40 PM — 2:00 PM

IBM Watson Health Innovation Theater: Real World Insights and Collaboration in Protocol Development

1:40 PM — 2:00 PM

UBC Innovation Theater: Standardizing and Enhancing Registry Data to Improve Evidence Generation

2:00 PM — 3:15 PM

Aligning Facilitated Regulatory and Access Pathways: Observations from the North American Experience

2:00 PM — 3:15 PM

Build-a-Bot Workshop: Design and Build a Conversational Agent that Speaks for You

2:00 PM — 3:15 PM

Clinical Trial Disclosure and Transparency: Intersection of Regulators, Industry, and Patients

2:00 PM — 3:15 PM

Clinical Trial Diversity: Moving from Admiring the Problem to Solving it

2:00 PM — 3:15 PM

Current Status of FDA Framework for the Evaluation of Real World Evidence

2:00 PM — 3:15 PM

Decision Leadership: How Using a Structured Approach to Decision Making Can Help You Lead Teams Better

2:00 PM — 3:00 PM

DIAlogue Session 2: Publications Meet Up - Inside the DIA Journal

2:00 PM — 3:15 PM

Driving Complex Generics to Approval: What are the Keys to Success

2:00 PM — 3:15 PM

Drug Development for Ocular Disease, New Therapies, Regulations, and Patient Perspectives

2:00 PM — 3:15 PM

Electronic Systems: Are Yours Fit for Purpose?

2:00 PM — 3:15 PM

FDA Data Standards Update

2:00 PM — 3:15 PM

Immuno-Oncology Product Development: Overcoming Scientific and Regulatory Challenges

2:00 PM — 3:15 PM

Master Protocols: Applications in Oncology

2:00 PM — 3:15 PM

Measuring the Impact of Patient Engagement Activities in Medicines R&D: A Way to Sustain the Cultural Change?

2:00 PM — 3:15 PM

Patient Experience Data: How Could this Data Enhance Decision-Making at Different Stages of Medical Product Development?

2:00 PM — 3:15 PM

Pharma and Regulatory Perspectives on Machine Learning Applications in Pharmacovigilance

2:00 PM — 3:00 PM

Pharma Powered by the Digital

2:00 PM — 3:15 PM

Presentations as Listeners Like Them: How to Tailor Messaging

2:00 PM — 3:00 PM

Round Table Discussion: Current Initiatives on Patient Involvement in the Medicinal Product Lifecycle: CIOMS XI

2:00 PM — 3:15 PM

Translating Academic Research Into Product Development: The What and Why of cGMP in Translational Science (Part 2 of 4)

2:00 PM — 3:15 PM

Wearables and Patient Technologies Utilized in Clinical Trials

2:00 PM — 3:15 PM

Where Quality Meets Safety and Efficacy: An Interactive Experience

3:15 PM — 4:15 PM

Access to Investigational Drugs Outside of Clinical Trials: What's Fair?

3:15 PM — 4:15 PM

Round Table Discussion: Clinical Research in Emerging Regions

3:15 PM — 4:15 PM

Round Table Discussion: Updates and Lessons Learned from Novel Approaches to Pharmacovigilance Collaboration

3:30 PM — 4:00 PM

Annual Meeting of Members

3:30 PM — 4:00 PM

How to Write a Compelling Poster Abstract

3:30 PM — 4:00 PM

Parexel and Microsoft Innovation Theater: Change The Way You Work: Transforming Regulatory Processes with Parexel and Microsoft

3:30 PM — 4:00 PM

PPD Innovation Theater: Have you Considered Market Access in Your Trial Design

4:15 PM — 5:30 PM

A Case Study in Structuring Clinical Content and Structured Content Management (SCM)

4:15 PM — 4:45 PM

Challenge of Regulatory Starting Material Designation and Its Implication on the Global Markets for the Post Approval Process

4:15 PM — 5:30 PM

Clinical Safety Assessment: What’s a Statistician Got to Do with It?

4:15 PM — 5:15 PM

Community Meet Up: Member Networking and Making the Most of your Membership

4:15 PM — 5:30 PM

Conversations with the Participant: Layperson Summaries and Return of Results

4:15 PM — 5:30 PM

Impact of Patient Engagement on the Biopharmaceutical Industry's Business and Organization

4:15 PM — 5:30 PM

Informing Development and Authorizations Using Real World Evidence/Artificial Intelligence

4:15 PM — 5:30 PM

Integration of Manufacturing Quality Assessment and Pre-Approval Inspections

4:15 PM — 5:30 PM

Let's Talk Risk-Based Monitoring

4:15 PM — 5:30 PM

Prescription Drug Labeling: New Guidances from the US FDA

4:15 PM — 5:30 PM

Public and Regulatory Response To Drug Pricing Concerns

4:15 PM — 5:30 PM

Real World Evidence: How Does its Use Challenge Quality and Compliance Programs?

4:15 PM — 5:30 PM

Structured Evidence Planning, Production, and Evaluation (SEPPE): A “Quality-Based” Framework for Drug Development

4:15 PM — 5:30 PM

The Changing Landscape of Medical Affairs: Are We Prepared For 2020?

4:15 PM — 5:30 PM

The Elephant in the Room: Meaningful Communication of Near Synonyms as Suspected Adverse Reactions

4:15 PM — 5:30 PM

The Machines are Here! Learn About Real Uses of Machine Learning and Artificial Intelligence in Pharma

4:15 PM — 5:30 PM

The Responsibility Industry, Agencies, and Early Education own in Cure-Model Based Therapeutics

4:15 PM — 5:30 PM

Update From the US FDA on Progress and Topics of Current Interest in US Biosimilar Policy, Regulation, and Outreach/Education

4:15 PM — 5:30 PM

Using Mobile Sensors in Clinical Trials and Evidentiary Considerations for Electronic Submissions

4:15 PM — 5:30 PM

Virtual Clinical Trials

5:00 PM — 6:00 PM

Community Meet Up: Medical Writing Community Meet and Greet

5:00 PM — 6:00 PM

Community Meet Up: Women in Life Sciences

Day 4 2019年6月26日 (水)

7:30 AM — 8:00 AM

Talent Show

8:00 AM — 9:15 AM

Can Topic-Based Approaches to Document Authoring Help Meet the Demands of Accelerated Marketing Application Timelines?

8:00 AM — 9:15 AM

Demystifying Technology Selection in Mobile Clinical Trials

8:00 AM — 9:15 AM

Designing Clinical Trials with the Right Endpoints: Applying ICH-E9(R1) - Getting the Questions Right (GTQR),Estimands and Handling Missing Data

8:00 AM — 9:15 AM

Disruptive Technology Transforming Clinical Trials: The Case for Artificial Intelligence, Blockchain, and Mobile Tech/Wearables

8:00 AM — 9:15 AM

How to Solve the Problem of Access for Rare Diseases

8:00 AM — 9:15 AM

Identifying High-Value Patient Engagement Opportunities: A Collaborative Three-Step Process for Sponsors and Patient Groups

8:00 AM — 9:15 AM

Implementation of Innovative and Adaptive Designs in Clinical Trials

8:00 AM — 9:15 AM

Improving Trial Quality by Better Preparing Site Teams

8:00 AM — 9:15 AM

Measuring and Assessing Product Manufacturing Quality

8:00 AM — 9:15 AM

Medical Devices: EU Medical Device Regulation, PMDA Updates, and US MDUFA IV – Where Are We Now?

8:00 AM — 9:15 AM

Methods for Integrating EHR Data into EDC and eSource Databases

8:00 AM — 9:15 AM

Model Integrated Evidence as Pivotal Information for Drug Regulatory Decision Making: When, Where, and Why

8:00 AM — 9:15 AM

Neoantigen-Based Cancer Therapies: Regulatory Challenges and Opportunities

8:00 AM — 9:15 AM

Operationalizing Master Protocols

8:00 AM — 9:15 AM

Opportunities and Challenges of Collecting Data in a Pre-Approval Access Setting: A Multi-Stakeholder Perspective

8:00 AM — 9:15 AM

Project Planning 101: Turning Strategy into Execution

8:00 AM — 9:15 AM

So Much Data, So Little Time: Hot Topics in Benefit-Risk Assessment

8:00 AM — 9:15 AM

Translating Academic Research into Product Development: The Importance of Understanding GLPs at an Early Stage (Part 3 of 4)

8:00 AM — 9:15 AM

Triple-s (3S) Smart Safety Surveillance

9:15 AM — 9:45 AM

Considering Consulting? The Good, the Bad, the Ugly, and the Profitable!

9:30 AM — 10:15 AM

One Size Does NOT Fit All: Know How to Adapt your Communication Style to be Effective Communicating Up, Down and Peer-to-Peer

9:30 AM — 10:30 AM

Round Table Discussion: Personalized Healthcare and Clinical Outcomes: How Real World Endpoints Can Improve Approval and Access to Medicine?

9:30 AM — 10:30 AM

Round Table Discussion: Real World Data to Real World Evidence

9:45 AM — 10:15 AM

Salesforce Innovation Theater: Digital R&D: Accelerating intelligent innovation with IQVIA’s Orchestrated Clinical Trials Platform, powered by Salesforce Health Cloud

9:45 AM — 10:15 AM

SAS Institute Inc JMP Innovation Theater: Semi-automation of the Narrative Section of the Clinical Study Report for Oncology Studies

10:00 AM — 10:30 AM

2020 and Beyond, Data Capture Across Systems, Functions, and Modalities

10:30 AM — 11:30 AM

A Pharma/CRO Partnership in the Design and Execution of Paperless Clinical Trials from eICF to Database Lock

10:30 AM — 11:30 AM

Achieving High Performance Through Emotional Intelligence

10:30 AM — 11:30 AM

Application of Project Management Methodologies and Tools in NonProfit Institutions

10:30 AM — 11:30 AM

DIAlogue Session 3: From My Crazy Career Path to Inside the Industry and How I Ended Up Here!

10:30 AM — 11:30 AM

Digital Risk Minimization: The “Next Generation” Risk Management Tools

10:30 AM — 11:30 AM

Digital Technology Advances Labeling Management and Patient Access

10:30 AM — 11:30 AM

Efficient Preparation of Global CMC Dossiers

10:30 AM — 11:30 AM

eSource Adoption: Where We Are - Our Experiences from eSource Implementation

10:30 AM — 11:30 AM

Expanding Use of Interactive Response Technologies in Clinical Trials: Maintaining Data Quality and Reliability

10:30 AM — 11:30 AM

Exploring the Evolving Requirements for the Clinical Assessment of Abuse and Dependence Potential of CNS-Active Drugs

10:30 AM — 11:30 AM

Global Clinical Trials: Make Them Really Global and Involve Africa

10:30 AM — 11:30 AM

Highlights of the Patient Engagement Preparedness, Capabilities, Experience, and Impact (PEPCEI) Study

10:30 AM — 11:30 AM

Hot Topics in Quality and Regulatory Affairs for Combination Products

10:30 AM — 11:30 AM

Meaningful Patient-Focused Drug Development for Rare Disease and Personalized Medicine

10:30 AM — 11:30 AM

Pediatric Plans: The Challenges Between Regulations and Reality

10:30 AM — 11:30 AM

Risk-Based Monitoring: Best Practice Today and Technology for Tomorrow

10:30 AM — 11:30 AM

The Analytics Revolution: Opportunities and Threats for Disrupting Clinical Development Operations

10:30 AM — 11:30 AM

The Evolving Gene Therapy Regulatory Framework: A Brave New World

10:30 AM — 11:30 AM

Understanding and Exploring Elements of a Patient-Focused Product Launch

10:30 AM — 11:30 AM

When is Real World Evidence Ready for Prime Time?

11:40 AM — 12:25 PM

IQVIA Innovation Theater: Clinical Development Innovation Through the Lens of Data Science

11:40 AM — 12:25 PM

ZS Innovation Theater: Designing With Confidence

12:30 PM — 1:00 PM

Project Managing Your Own Leadership Journey

12:30 PM — 1:30 PM

Regulatory Affairs Governance: Benchmarking and Sharing of Best Practices

12:40 PM — 1:25 PM

IQVIA Innovation Theater: The Digital Patient Experience

12:40 PM — 1:25 PM

Oracle Health Sciences Innovation Theater: The AI Revolution in Multivigilance

12:45 PM — 1:45 PM

Round Table Discussion: An Industry Collaboration on Pharmacovigilance Analytics

12:45 PM — 1:45 PM

Round Table Discussion: Clinical Trial Disclosure and Transparency: Intersection of Regulators, Industry, and Patients

1:15 PM — 1:45 PM

The Current and Future State of RIM

1:40 PM — 2:00 PM

PRA Health Sciences Innovation Theater: The Importance and Impact of Age Specific Content in Pediatric Studies

1:40 PM — 2:00 PM

Tata Consultancy Services: Enabling Perpetual Digital Transformation in Research & Development

2:00 PM — 3:15 PM

Accelerating Drug Development via Structured Content Reuse: Introducing the TransCelerate Clinical Template eSuite

2:00 PM — 3:15 PM

Advancing Value and Access With Technology

2:00 PM — 3:15 PM

Challenges and Opportunities in Product Quality: Lifecycle Management

2:00 PM — 3:15 PM

Effective Portfolio Management of Assets Across an Organization

2:00 PM — 3:15 PM

Efficient Pediatric Drug Development: Incorporating Innovative Techniques Using Extrapolation and Historical Information

2:00 PM — 3:00 PM

Enabling Patient-Centric Clinical Studies: TransCelerate’s Patient Engagement Tools

2:00 PM — 3:15 PM

Global Rare Disease Town Hall

2:00 PM — 3:15 PM

History of Risk Evaluation and Mitigation Strategies (REMS): What Have We Learned?

2:00 PM — 3:15 PM

Identification of Medicinal Products: FDA's Perspective and Approach

2:00 PM — 3:15 PM

Improving the Trial Experience for Rare Disease Patients: Identifying and Overcoming Obstacles

2:00 PM — 3:15 PM

Involving Patients in Medicinal Product Benefit-Risk Communication: How're We Doing?

2:00 PM — 3:15 PM

Leveraging Data Analytics to Drive Compliance and Quality in a Risk-Based Monitoring Environment

2:00 PM — 3:15 PM

Model-Informed Drug Development (MIDD) and Complex Innovative Designs (CID) Programs: Where are We and What Have We Learned?

2:00 PM — 3:15 PM

Neurodegenerative Diseases: Early-Stage Challenges and Optimal Models in Drug Development

2:00 PM — 3:15 PM

Patient Engagement Quality Guidance: Results and Learnings from Global Multistakeholder Pilots

2:00 PM — 3:15 PM

Returning Plain Language Summaries to Research Participants: Best Practices and the Role of the IRB

2:00 PM — 3:00 PM

Round Table Discussion: Can Topic-Based Approaches to Document Authoring Help Meet the Demands of Accelerated Marketing Application Timelines?

2:00 PM — 3:00 PM

Round Table Discussion: The Elephant in the Room: Meaningful Communication of Near Synonyms as Suspected Adverse Reactions

2:00 PM — 2:30 PM

Success in the Workplace: What Does That Mean and How Can You Achieve it?

2:00 PM — 3:15 PM

Training for the Electronic Capture of PRO Data in Clinical Trials: Views from ePRO Vendors, Sponsors, Sites, and Patients

2:00 PM — 3:15 PM

Translating Academic Research into Product Development: Integrating GCP Training into the Process (Part 4 of 4)

2:00 PM — 3:15 PM

User-Fee Programs Myth Busting: General Financial Principles Explained

3:15 PM — 4:00 PM

Assessing Medical Adherence in a Clinical Trial Setting: Challenges and Solutions

3:15 PM — 4:15 PM

Round Table Discussion: Master Protocols: Applications in Oncology

3:15 PM — 4:15 PM

Round Table Discussion: Pharma and Regulatory Perspectives on Machine Learning Applications in Pharmacovigilance

3:30 PM — 4:00 PM

Measuring “Value” in Value-Based Healthcare: A Health Economics Perspective

3:30 PM — 4:00 PM

On the Soapbox: Good for People and Good for Research - Individuals as Research Partners

4:15 PM — 5:30 PM

A New Path Forward for Using Decentralized Clinical Trials

4:15 PM — 5:30 PM

Breakthrough Therapy and PRIME Expedited Regulatory Pathways: Experience, Analysis, and Reflections from EMA, FDA, and Industry

4:15 PM — 5:30 PM

Case Studies in Resolving Quality Issues

4:15 PM — 5:30 PM

Challenges to Access: Bringing Payers to the Table

4:15 PM — 5:30 PM

Clinical Trial Innovation: Pathways for Selecting and Developing Novel, Fit-for-Purpose, Technology-Derived Study Endpoints

4:15 PM — 5:30 PM

Convergence of the Regulatory Pathways for Advanced Therapy Medicinal Products

4:15 PM — 5:30 PM

Demystifying Basic Statistical Concepts for Anyone Involved with Clinical Trials

4:15 PM — 5:30 PM

From Trials to Real World: How Safety Protocols Impact REMS

4:15 PM — 5:30 PM

Global Perspective on ICH E8(R1): General Considerations for Clinical Trials

4:15 PM — 5:30 PM

Incorporating Patient Input into the Design and Conduct of Clinical Trials

4:15 PM — 5:30 PM

Next-Generation Approaches for Developing Narratives

4:15 PM — 5:30 PM

Patient Preferences in Decision Making and the PREFER Project: Past, Present, and Future

4:15 PM — 5:30 PM

PowerUp: Stories of Career Transforming Moments

4:15 PM — 5:30 PM

Real World Data Quality for Regulatory Decision-Making

4:15 PM — 5:30 PM

Real World Evidence and Artificial Intelligence to Inform Post-Authorization Studies

4:15 PM — 5:30 PM

Setting the Stage for Effective Stakeholder Collaboration

4:15 PM — 5:30 PM

The Importance of Human Translation for Successful Preclinical Drug Discovery and Cardiac Safety

4:15 PM — 5:30 PM

Transparency, Expanded Access Navigator, Right to Try: Helping Patients Get Access to Investigational Medicines?

4:15 PM — 5:30 PM

Utilization and Evaluation of Innovative Approaches for Efficient Drug Development

4:30 PM — 5:30 PM

Round Table Discussion: Digital Risk Minimization: The “Next Generation” Risk Management Tools

Day 5 2019年6月27日 (木)

8:30 AM — 9:00 AM

Manage Risks and Enhance Engagement Through Digital Approaches

9:00 AM — 10:15 AM

A Patient Engagement Wrap Up: Lessons Learned from DIA 2019 and Where Do We Go from Here

9:00 AM — 10:15 AM

Advancing Benefit-Risk Assessment to Support FDA’s Regulatory Review of Human Drugs and Biologics

9:00 AM — 10:15 AM

Case Studies From FDA and MHRA: Good Clinical Practices

9:00 AM — 10:15 AM

Electronic Submissions Update

9:00 AM — 10:15 AM

eSource and the Sites: Have They Bonded?

9:00 AM — 10:15 AM

FDA Botanicals

9:00 AM — 10:15 AM

Investigational Medicinal Products: eLabeling Initiative, Supply Forecasting Strategies, and Patient-Centric Technology for Medicine Adherence

9:00 AM — 10:15 AM

Keeping Up with FDA and EMA Collaborations: Question Time

9:00 AM — 10:15 AM

Recent CMC Changes in Emerging Regulatory Agencies

9:00 AM — 10:15 AM

Successes and Challenges in Pharmacovigilance for Biologics and Biosimilars

10:45 AM — 12:00 PM

FDA Town Hall

DIA 2019 Global Annual Meeting

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