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McCormick Place

Jun 18, 2017 8:30 AM - Jun 22, 2017 12:45 PM

2301 South Martin Luther King Jr. Drive, Gate 4, Chicago, IL 60616

DIA 2017 Annual Meeting

Agenda

8:30 AM — 12:00 PM

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

8:30 AM — 12:00 PM

#21: Successful Drug Development: Best Practices for Drug Development Planning, Agency Interactions, and Regulatory Document Writing

8:30 AM — 12:00 PM

#22: How to Prepare for an FDA Inspection

8:30 AM — 12:00 PM

#23: Signal Detection: Identifying and Managing Safety Signals

8:30 AM — 12:00 PM

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

8:30 AM — 12:00 PM

#25: Regulatory Considerations for Drug Development: Current Status and Trend of IND/NDA Practice in China

8:30 AM — 12:00 PM

#25: Regulatory Considerations for Drug Development: Current Status and Trend of IND/NDA Practice in China

8:30 AM — 12:00 PM

#26: Smart, Innovative Risk-based Auditing: Shifting the Paradigm

8:30 AM — 12:00 PM

#26: Smart, Innovative Risk-based Auditing: Shifting the Paradigm

9:00 AM — 5:00 PM

#40: Clinical Statistics for Nonstatisticians

9:00 AM — 5:00 PM

#40: Clinical Statistics for Nonstatisticians

9:00 AM — 5:00 PM

#42: Analysis of Safety Data from Clinical Trials

9:00 AM — 5:00 PM

#43: The Good Pharmacovigilance Practices in the EU: Global Applications

10:30 AM — 12:00 PM

Student Session

1:00 PM — 4:30 PM

#30: Preparing for a US FDA Advisory Committee Meeting

1:00 PM — 4:30 PM

#31: Influencing Culture, Avoiding Bureaucracy, and Encouraging Innovation

1:00 PM — 4:30 PM

#32: Preparation of Risk Evaluation and Mitigation Strategies Assessment Reports

1:00 PM — 4:30 PM

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

1:00 PM — 4:30 PM

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

1:00 PM — 4:30 PM

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

1:00 PM — 4:30 PM

#35: Digital Health Technologies for Combination Products and Beyond: Development and Regulation

2:45 PM — 4:00 PM

To Change or Not to Change, That is the Career Question: Knowing When it’s Time to Move On (Not, Run From)

4:15 PM — 5:30 PM

Networking Within Your Company

8:30 AM — 10:00 AM

Drug Repurposing: Where Will it Take Us?

8:30 AM — 10:00 AM

The Evolution of Evidence Generation: Real-World Evidence and the Next Generation of Decision Making

8:30 AM — 10:00 AM

The Future of Patient Engagement: Measuring What Matters

10:15 AM — 10:45 AM

Cenduit LLC Innovation Theater: High-Profile Early Onset Alzheimer’s Disease Study in an Academic Setting Requiring Highly Configurable IRT System for Complex Study Design.

10:15 AM — 10:45 AM

DBMS Consulting Innovation Theater: Replacing dsNavigator with Oracle TMS as a centralized coding solution

11:00 AM — 12:15 PM

Artificial Intelligence/Machine Learning

11:00 AM — 12:15 PM

Breaking Down the Wall for FDA to Leverage Real World Data

11:00 AM — 12:15 PM

Calling All Angels to the Valley of Death

11:00 AM — 11:30 AM

Career Opportunities in Transitions in Life Science

11:00 AM — 12:15 PM

Counting on Safety

11:00 AM — 12:15 PM

Data Sharing: 2017 and Beyond

11:00 AM — 12:15 PM

Designing and Implementing a Robust Pharmacovigilance System for Vaccines

11:00 AM — 12:15 PM

Effective Life Cycle Management

11:00 AM — 12:15 PM

Engage and Exchange Student Forum

11:00 AM — 12:15 PM

Exploration of PK/PD in NDA Enabling or Early Proof of Concept Studies

11:00 AM — 12:15 PM

FDA Rare Disease Town Hall

11:00 AM — 12:15 PM

GBM AGILE: A Transformative Global Adaptive Platform Clinical Trial

11:00 AM — 12:15 PM

Globalization of Medical Affairs Departments

11:00 AM — 12:15 PM

Hybrid Study Designs: An Innovative Approach to Obtaining Valuable Information by Combining Existing Data with New Data Length

11:00 AM — 12:15 PM

Leveraging Big Data/ Real-World Data in Enabling Efficient and Data-Driven Clinical Research From Sponsor, Vendor and National Health System Perspective: Case Studies

11:00 AM — 12:15 PM

Leveraging Wearables and Sensors in Clinical Trials and mHealth

11:00 AM — 12:15 PM

Office of Pharmaceutical Quality Update: Innovative Approaches in Regulatory Assessment

11:00 AM — 12:15 PM

Patient Engagement: 4 W's and an H

11:00 AM — 12:15 PM

PDUFA at 25: A Historical View of the Prescription Drug User Fee Agreement and a Look to the Future - PDUFA VI

11:00 AM — 12:15 PM

Postmarketing Safety Studies: Approaches and Regulatory Insights

11:00 AM — 12:15 PM

Submission Dossiers: Communications Excellence to Drive Speed and Quality

11:00 AM — 12:15 PM

The Evolving International Landscape of FDA Inspections: Data Integrity Violations in Bioequivalence Studies in India

11:00 AM — 12:30 PM

Update from the CFDA

11:00 AM — 12:15 PM

We Can't Forget the Children in This Process

11:45 AM — 12:15 PM

A Day in the Life of A....

12:30 PM — 1:30 PM

DIA Patient Engagement Community Round Table Discussion: The Future of Patient Engagement: Measuring What Matters

12:30 PM — 1:00 PM

QuintilesIMS Innovation Theater: The Next Generation of Clinical Development is Here

12:30 PM — 1:00 PM

Tata Consultancy Services Innovation Theater: Global Regulatory Information Portal (GRIP) – A Regulatory Information Strategic Effectiveness Portal

1:15 PM — 1:45 PM

Covance Innovation Theater: Lessons Learned From Deploying Clinical Data Review: Ensuring Patient Safety, Increasing Operational Efficiency and Creating New Insights

1:15 PM — 1:45 PM

Day in the Life of A…Part 2

1:15 PM — 1:45 PM

PAREXEL International Innovation Theater: Developing Drugs in the New Era of Personalized Medicines

1:15 PM — 2:15 PM

The Worst Coworker on the Block: Can YOU Work with Difficult People? Yes, You Can!

1:45 PM — 2:45 PM

DIA Medical Writing Community Round Table Discussion: Submission Dossiers: Communications Excellence to Drive Speed and Quality

2:00 PM — 2:30 PM

Deloitte Consulting Innovation Theater: 21st Century Cures and Person-Centered Research: A Recipe for Innovation

2:00 PM — 2:30 PM

SAS Institute Inc. Innovation Theater: Clinical Analytics Workflow Optimization

3:00 PM — 4:30 PM

Opening Remarks and Keynote Address

4:45 PM — 5:15 PM

Advanced Clinical Innovation Theater: Avoid Systems Overload: Connecting and Operationalizing Disparate Technology Systems Supporting Clinical Trials

4:45 PM — 5:15 PM

Educational Measures Innovation Theater: EM Array™ Live Meeting Technology

5:30 PM — 6:00 PM

Appian Innovation Theater: Product Lifecycle Management In The Digital Era

5:30 PM — 6:00 PM

DBMS Consulting Innovation Theater: Manage Customized SMQs/MedDRA Queries and Customized SDGs/Drug Groupings and Facilitate Risk Profiling and Safety Analysis with OpenCQT

8:00 AM — 9:30 AM

Paying for Value in Biopharmaceuticals: Trends in the United States

8:00 AM — 9:30 AM

People Will Talk: Gathering Insights from Digital Listening

8:00 AM — 9:30 AM

Radical Technologies: Changing the Future of Biopharmaceuticals

9:30 AM — 10:30 AM

Effective Team Management in Global Trials

9:45 AM — 10:15 AM

Covance Innovation Theater: Overcoming Study Complexity Through Data-Driven Design

9:45 AM — 10:15 AM

Veeva Systems, Inc. Innovation Theater: 2017 Unified Clinical Operations Survey

10:30 AM — 11:00 AM

A Risk-Based Approach to Quality Management for RWE Studies

10:30 AM — 11:45 AM

Accelerating Drug Development Through Innovation

10:30 AM — 11:45 AM

At the Cornerstone of Wearable Technology and Patient-Focused Clinical Trial Endpoints

10:30 AM — 11:45 AM

Big Data: Regulatory Information

10:30 AM — 11:30 AM

Cardiac Safety

10:30 AM — 11:30 AM

ClinicalTrials.gov: Complying with Requirements in the Final Rule (42 CFR Part 11) and Impacts of 21st Century Cures Act

10:30 AM — 11:30 AM

DIA Study Endpoints Community Round Table Discussion: Leveraging Wearables and Sensors in the Clinical Trials and mHealth

10:30 AM — 11:45 AM

Evolving Data Standards and Regulations

10:30 AM — 11:45 AM

Global Harmonization: Mutual Recognition

10:30 AM — 11:45 AM

International Collaboration in Times of Public Health Crisis

10:30 AM — 11:45 AM

Introduction to Rare Disease Studies: Challenges of Rare Disease From a Statistical, Protocol Development, and Operations Perspective

10:30 AM — 11:45 AM

Master Protocols: New Approaches to Enrolling Hard-to-Find Subjects and Expediting Drug Development

10:30 AM — 11:45 AM

Outcomes Standardization: An Imperative to Value Assessments

10:30 AM — 11:45 AM

Pharmacovigilance Inspections: Hot Topics and Proactive Approaches

10:30 AM — 11:45 AM

Recent Trends in Asian Regulations for Drug Development: What is Coming Next?

10:30 AM — 11:45 AM

Regulatory Frameworks: How Can Regulators Facilitate Disruptive Innovation?

10:30 AM — 11:45 AM

Safety Evaluation: Transforming Information into Evidence

10:30 AM — 11:45 AM

Serving the Patient Who Needs Early Access to Treatments and Achieving Meaningful Outcomes

10:30 AM — 11:45 AM

Sharing the Burden

10:30 AM — 11:45 AM

So You Say You're an Extrovert: Being an Effective Leader when All You Really Want Is a Stage

10:30 AM — 11:45 AM

Success in Early CNS Drug Development: Getting Proof-of-Principle by Stacking the Deck with Biomarkers

10:30 AM — 11:45 AM

The Evolving Model of Using Artificial Intelligence to Deliver Actionable Regulatory Intelligence

10:30 AM — 11:45 AM

The New Business Reality for the Medical Science Liaison Community

10:30 AM — 11:30 AM

Update from CBER: Advancing the Development of Complex Biologic Products

10:30 AM — 11:45 AM

Walking the Walk in Patient Focused Medicines Development: From Theory to Practice What Have We Learned?

10:45 AM — 11:45 AM

Healthy CRO/Sponsor Relations: “Sole” Mate or Flavor of the Month

12:00 PM — 12:45 PM

Amplexor Innovation Theater: Reduce Complexity – Increase Compliance – Decrease TCO’s: Regulatory Vendor Promises - Innovations or Buzzwords?

12:00 PM — 1:00 PM

DIA Communities Luncheon

12:00 PM — 12:45 PM

QuintilesIMS Innovation Theater: Changing Trials Through Analytics: How it Works

12:45 PM — 1:30 PM

PowerUp!

12:45 PM — 1:45 PM

Strategies for Communicating with FDA

1:00 PM — 1:45 PM

Bioclinica Innovation Theater: Case Studies: How Companies Are Finally Reaping the Benefits of Risk-Based Monitoring.

1:00 PM — 1:45 PM

DIA Patient Engagement Community Round Table Discussion: Walking the Walk in Patient Focused Medicines Development: From Theory to Practice What Have We Learned?

1:00 PM — 1:45 PM

Veeva Systems, Inc. Innovation Theater: Tomorrow's Clinical Trial, Powered by Modern EDC

1:15 PM — 1:45 PM

Strategies for Managing Difficult Stakeholders

2:00 PM — 3:15 PM

Best Practice for Advisory Committee Meeting Preparation

2:00 PM — 3:15 PM

Big Data: Current and Emerging Technologies

2:00 PM — 3:15 PM

Building the Medical Strategy and Tactics

2:00 PM — 3:15 PM

Clinical Relevant Specifications: Leveraging Principles of QbD

2:00 PM — 3:00 PM

Comparative Effectiveness: State of the Art and Stakeholder Perspectives

2:00 PM — 3:15 PM

Comparison of Inspection Findings and Recommendations of Registration Trials Submitted in Support of Marketing Applications of New Drug Products to EMA and FDA

2:00 PM — 3:00 PM

Data and Privacy Protection

2:00 PM — 3:15 PM

Defining the Science of Patient Input to Enhance Drug Development and Approval: Regulatory

2:00 PM — 3:00 PM

DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Pharmacovigilance Inspections: Hot Topics and Proactive Approaches

2:00 PM — 3:15 PM

FDA Session: Electronic Submissions and Data

2:00 PM — 3:15 PM

If You See Something (About a Clinical Trial), Do You Say Something (to Your Doctor?)

2:00 PM — 3:15 PM

Integrating the Patient's Voice Across the Development Program of Rare Diseases: Translation Into Meaningful Outcomes

2:00 PM — 3:15 PM

Leveraging Wearables and Sensors in Clinical Trials: Case Studies

2:00 PM — 3:15 PM

Medical Information and the Patient: Effective Communication and Handling of Requests

2:00 PM — 3:00 PM

Mergers and Acquisitions: Due Diligence Considerations

2:00 PM — 3:15 PM

Mobile Health: Participatory Research

2:00 PM — 3:15 PM

New Considerations in Benefit-Risk Management

2:00 PM — 3:15 PM

New Trial Design Approaches: Including New Endpoints

2:00 PM — 3:15 PM

Not Your Grandma's Patient Advocacy Group Anymore

2:00 PM — 3:15 PM

Novel Techniques for Improving Clinical Trial Subject Retention

2:00 PM — 3:15 PM

Patient-Reported Outcomes (PROs): Hot Topics - Part 1 of 2

2:00 PM — 3:15 PM

Post-Trial Access: Ensuring Patient Access Across the Development Spectrum

2:00 PM — 3:15 PM

Regulatory Challenges with Next Generation Sequencing

2:00 PM — 3:15 PM

Strategic Planning Across Research Organizations

2:00 PM — 3:15 PM

What’s New in Devices: European Medical Device Regulations and MDUFA IV

2:45 PM — 3:15 PM

Patient Engagement in Study Endpoints: Will the Rising Tide Lift All Boats?

3:25 PM — 3:55 PM

BBK Worldwide Innovation Theater: Building a Patient-Centric Mindset through Theatrical Contemplation

3:25 PM — 3:55 PM

Veeva Systems, Inc. Innovation Theater: Unified RIM: End-to-end Submissions Development—from Planning Through Archival

4:00 PM — 5:00 PM

Audits and Agency Inspections of Risk-Based Monitored Studies: The Results Are In...

4:00 PM — 5:15 PM

Big Data: Genomics and Personalized Medicine

4:00 PM — 5:15 PM

Breaking Down the Wall for Global Regulators to Leverage Real World Data

4:00 PM — 5:15 PM

Brexit: Where Are We Now?

4:00 PM — 5:15 PM

Challenges and Issues in Early-Phase Oncology Trials

4:00 PM — 5:00 PM

Combination Products

4:00 PM — 5:15 PM

Creating Adaptive Contents for a Multichannel World

4:00 PM — 5:15 PM

Data Quality

4:00 PM — 5:15 PM

Defining the Science of Patient Input to Enhance Drug Development and Approval: Tools

4:00 PM — 5:15 PM

Developing Pharmacovigilance Policy Based on Impact

4:00 PM — 5:15 PM

Effective Collaboration Between Sponsors and Medical Writing Vendors

4:00 PM — 5:00 PM

FDA Session: Health IT at FDA

4:00 PM — 4:30 PM

How eSource Solutions are Impacting Clinical Research Sites, Patients, Regulators and Drug and Device Companies

4:00 PM — 5:15 PM

Integrating the Patient's Voice Across the Development Program of Rare Diseases: At the Table - Where to Sit?

4:00 PM — 5:00 PM

Microbiome: Innovative Therapeutics, Challenges, and Opportunities

4:00 PM — 5:15 PM

Next Generation Patient Recruitment: Part 1 of 2

4:00 PM — 5:15 PM

Partnering with Patients: Virtual and Traditional Communities - When for What

4:00 PM — 5:15 PM

Patient-Reported Outcomes (PROs): Hot Topics - Part 2 of 2

4:00 PM — 5:15 PM

PMDA Town Hall

4:00 PM — 5:15 PM

Quality Metrics: The Carrot or the Stick?

4:00 PM — 5:15 PM

The Impact of Industry Consortia on Creating Collaborative Solutions to Drug Development Challenges: What Does the Future Hold?

4:00 PM — 5:15 PM

The Reauthorization of BsUFA and its Impact on Both the Regulator and Industry

4:00 PM — 5:15 PM

Use of Novel Trial Designs to Accelerate Decision Making: To 'P' No More

4:00 PM — 5:15 PM

Value and Access for Special Populations: From Access Restriction to Drug Mortgages

4:00 PM — 5:15 PM

What Question Are You Trying to Answer? The Use of Estimands, Potential Revisions to ICH E-9 and the Impact to Trial Design and Analysis

4:45 PM — 5:15 PM

Conversations That Matter: How do Regulatory Affairs Professionals Wish to Engage with Statisticians and Vice Versa?

5:30 PM — 6:30 PM

DIA Study Endpoints Community Meeting

8:00 AM — 9:30 AM

Does Diversity Matter in Clinical Trials?

8:00 AM — 9:30 AM

International Regulatory Convergence

8:00 AM — 9:30 AM

Progress in Pediatric Therapeutics

9:30 AM — 10:30 AM

Mergers and Acquisitions: First, Do No Harm

9:45 AM — 10:15 AM

SAS Institute Inc, JMP Division, Innovation Theater: Work with Me Here...(or There or Anywhere!): Practical Cloud Collaboration with JMP Clinical

9:45 AM — 10:15 AM

Synchronoss Innovation Theater: Applying Telecom’s Mobility Best Practices to mHealth

10:30 AM — 11:45 AM

A New Age for Physician and Patient Labeling: Recommendations for Innovative Change in How We Communicate

10:30 AM — 11:45 AM

Big Data: Combining Registries and Legacy Clinical Trial Databases

10:30 AM — 11:00 AM

Conversations that Matter: How do Pharmacovigilance Professionals Wish to Engage With Statisticians and Vice Versa?

10:30 AM — 11:45 AM

CRISPR: Regulatory Challenges in the Gene Editing Revolution

10:30 AM — 11:45 AM

Digital Channels and Artificial Intelligence in Medical Information and Communications

10:30 AM — 11:45 AM

Effective Collaborations: Navigating the Grey Space

10:30 AM — 11:45 AM

Engagement, Education, Networks, Media, and Societies in Rare Diseases: The MUST Haves

10:30 AM — 11:45 AM

Evolution of Novel Registration Endpoints as Diseases Become Chronic

10:30 AM — 11:45 AM

How to Engage Patients Within Medical Affairs

10:30 AM — 11:45 AM

IMEDS: A Public-Private Partnership to Facilitate Real World Evidence Generation Based on the FDA's Sentinel System

10:30 AM — 11:45 AM

Is the Future Bright for Treatment of Neurodegenerative Diseases?

10:30 AM — 11:45 AM

Keys to Effective Product Launch Preparation

10:30 AM — 11:45 AM

Leading in the Midst of Ambiguity

10:30 AM — 11:45 AM

Managing Acceleration and Quality In Product Development

10:30 AM — 11:45 AM

Measuring and Advancing the Clinical Quality Management System

10:30 AM — 11:45 AM

Multiregional Clinical Trials and the ICH E17

10:30 AM — 11:45 AM

New Frontiers in Pharmaceutical Manufacturing

10:30 AM — 11:45 AM

New Site Paradigm: Just in Time Sites

10:30 AM — 11:45 AM

Next Generation Patient Recruitment: Part 2 of 2

10:30 AM — 11:45 AM

Optimizing Early Clinical Strategies to Support Breakthrough Therapy Designation

10:30 AM — 11:30 AM

Quantified Self Tracking

10:30 AM — 11:45 AM

Quantitative Metrics to Capture the Value of Patient Engagement

10:30 AM — 11:45 AM

Real-World Data to Real World Evidence for Assessing Efficacy and Effectiveness

10:30 AM — 11:45 AM

The Brave New World: The Ongoing Globalization of Pharmacovigilance

10:45 AM — 11:45 AM

Patient Perspective

11:15 AM — 11:45 AM

Information Quality in EHR Computer Systems

12:00 PM — 12:45 PM

Accenture Innovation Theater: The Digital Clinical Trial – Placing the Right Bets

12:00 PM — 12:45 PM

Cognizant Technology Solutions Innovation Theater: The Shared Investor Platform - An Innovative Open Technology Powering New possibilities for Site -Sponsor Relationship

12:00 PM — 12:45 PM

DIA Patient Engagement Community Round Table Discussion: Real-World Data to Real World Evidence for Assessing Efficacy and Effectiveness

12:45 PM — 1:45 PM

Real-World Application of Risk-Based Monitoring

1:00 PM — 1:45 PM

DIA Regulatory Affairs Community, Regulatory Intelligence WG Round Table Discussion: The Evolving Role of Using Artificial Intelligence to Deliver Actionable Intelligence

1:00 PM — 1:45 PM

QuintilesIMS Innovation Theater: Connecting People and Trials Through Innovative Technologies

2:00 PM — 3:15 PM

Adoption and Implementation of Digital Platforms to Further Patient Interactions

2:00 PM — 3:15 PM

Big Data: Management and Analytics

2:00 PM — 3:00 PM

Biosimilars and Generics: Access Versus Innovation

2:00 PM — 3:15 PM

Collaborative Efforts to Accelerate Rare Disease Research and Development

2:00 PM — 3:00 PM

Cultural Diversity

2:00 PM — 3:15 PM

Digital Innovations for Medical Information Contact Centers

2:00 PM — 3:15 PM

EMA Policy 0070: A Game Changer for Industry

2:00 PM — 3:15 PM

Expanded Access and Compassionate Use

2:00 PM — 3:15 PM

Experimental Studies: New Approaches to Study Designs to Facilitate Early Phase Decision Making

2:00 PM — 3:15 PM

Exploring the Evolution of Signal Detection

2:00 PM — 3:15 PM

FDA, NIH, and TransCelerate Collaborate to Accelerate Drug Development Through Protocol Harmonization

2:00 PM — 3:15 PM

Global Perspective on ICH: Part 1 of 2

2:00 PM — 3:15 PM

Innovative Designs and Statistical Approaches for Small Trials: Rare Disease or Pediatric Indications

2:00 PM — 3:15 PM

Integrated Life Cycle Approaches to Benefit -Risk Assessment, Communication, and Evaluation

2:00 PM — 3:15 PM

Life Cycle Management: ICH Q12

2:00 PM — 3:15 PM

Minding the Gaps: Using Totality of Evidence in the Clinical and CMC Contexts to Support Regulatory Approval

2:00 PM — 3:15 PM

Off-Label Communications to Health Care Providers and Consumers

2:00 PM — 3:15 PM

Pharmacovigilance 2.0: Redesigning for the Future

2:00 PM — 3:15 PM

Pregnancy and Lactation Labeling Rule: Unique Challenges to Meet Requirements

2:00 PM — 3:15 PM

Risk-Based Monitoring: Convergence of Technology, Processes, and People

2:00 PM — 3:15 PM

Understanding the New Common Rule and Its Impact to Industry

2:00 PM — 3:15 PM

Value-Based Conversations with Payers: Issues, Opportunities, and Barriers

2:00 PM — 3:15 PM

What Do the Experts Believe? Translating Expert Knowledge and Judgment Into a Quantitative Belief Distribution

2:45 PM — 3:15 PM

Online Health Communities: A New Frontier in Health Research

3:15 PM — 4:00 PM

Medical Affairs and KOL Management

4:00 PM — 5:15 PM

Are We Ready for Telemedicine-Powered Clinical Trials?

4:00 PM — 5:15 PM

Automation and Innovation in Clinical Trial Safety Assessment

4:00 PM — 5:15 PM

Changing Environments Within Pharmacovigilance

4:00 PM — 5:00 PM

DIA Medical Writing Community Round Table Discussion: EMA Policy 0070:A Game Changer for Industry

4:00 PM — 5:15 PM

Effective Portfolio Management and How to Ensure You Get the Value Out of the Decisions Made

4:00 PM — 5:15 PM

EHRs/eSource and Emerging Data Streams

4:00 PM — 5:15 PM

FDA Update on Prescription Drug Promotion

4:00 PM — 5:00 PM

FDA–Health Canada Regulatory Cooperation Council Town Hall

4:00 PM — 5:15 PM

Global and Regional Collaboration Initiatives: Challenges, Opportunities, and Case Studies

4:00 PM — 5:15 PM

Global Perspective on ICH: Part 2 of 2

4:00 PM — 5:15 PM

How Is Digital Patient Engagement Impacting Trial Participation?

4:00 PM — 5:15 PM

Increasing Participation in Clinical Trials Among Under-Represented Populations

4:00 PM — 5:15 PM

Lessons Learned from the Sarepta Exondys 51 Approval

4:00 PM — 5:15 PM

Looking to the Future for EU Pediatric Investigation Plans

4:00 PM — 5:15 PM

Maximizing Success in Partner Collaborations

4:00 PM — 5:15 PM

Next Generation Predictive Analytics

4:00 PM — 5:15 PM

Patient-Centric Development Assessment

4:00 PM — 5:15 PM

Patient-Relevant, Fit-For-Purpose Endpoints: If You Can Believe It, You Can Achieve It

4:00 PM — 5:15 PM

Risk-Based Monitoring: Convergence of Technology, Processes, and People: Panel Discussion

4:00 PM — 5:15 PM

Safety Issues in First-in-Human Studies

4:00 PM — 5:15 PM

The Art of Negotiation: Preparing Yourself and Your Team for Their Seat at the Table

4:00 PM — 5:15 PM

The Increasing Role for Big Data for Late Phase Drug and Postapproval Purposes

4:00 PM — 5:15 PM

The Reauthorization of GDUFA and Its Impact on Sponsor and Regulator

4:00 PM — 5:15 PM

Writing of Layperson Summaries of Clinical Trial Results According to the EU: Regulation and Its Impact on Global Pharmaceutical Activities

5:30 PM — 6:30 PM

DIA Clinical Safety and Pharmacovigilance Community Meeting

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