Agenda
8:30 AM — 12:00 PM
#22: Protocol Co-Design with Patients and Advocates8:30 AM — 12:00 PM
#24: Preparing for a US FDA Advisory Committee Meeting8:30 AM — 12:00 PM
#25: Precedent: A Driver of Regulatory Strategy8:30 AM — 12:00 PM
#28: Preparing Documents for Disclosure and Public Sharing8:30 AM — 12:00 PM
#29: Leadership: How to Organize and Lead People in a Work Group9:00 AM — 5:00 PM
#40: Smart, Innovative Risk-Based Auditing: Shifting the Paradigm9:00 AM — 5:00 PM
#42: Back to the Future: Combination Products in the 21st Century10:30 AM — 12:00 PM
Emerging Professionals and Student Forum1:00 PM — 4:30 PM
#31: Machine Learning in Pharmacovigilance1:00 PM — 4:30 PM
#31: Machine Learning in Pharmacovigilance1:00 PM — 4:30 PM
#37: Data Visualization in the Life Sciences3:00 PM — 4:00 PM
Effective Use of Social Media4:15 PM — 5:30 PM
The Power of Networking8:30 AM — 10:00 AM
Opening Plenary Session and Keynote Speaker10:15 AM — 11:00 AM
Networking Do's and Don'ts10:30 AM — 11:00 AM
LinkedIn Review11:00 AM — 12:15 PM
A Hot Debate: Perspectives on Benefit and Risk From Patients Across Diseases11:00 AM — 12:30 PM
Analyzing Innovations Progress in the Gottlieb Era11:00 AM — 12:00 PM
Beyond Robotics Process Automation: Next Generation Integrated QMS for R&D11:00 AM — 12:15 PM
FDA Innovation in Pharmaceutical Quality Assessment and Inspection11:00 AM — 12:15 PM
Scientific Communication Key Message Development, Management, and Dissemination11:00 AM — 12:15 PM
Signal Management: Separating Needles From Haystacks11:00 AM — 12:15 PM
The Who, What, How, When, and Why of Using Mobile Technology in Clinical Trials11:00 AM — 12:15 PM
Use of Historical Information in Clinical Trial Design11:00 AM — 12:15 PM
Using Fast Healthcare Interoperability Resources (FHIR®) for Clinical Research12:30 PM — 1:00 PM
EU Global Data Protection Regulation and Impact on US Companies12:30 PM — 1:30 PM
Organizational Change and Knowledge Management for Cybersecurity Threats1:15 PM — 1:45 PM
Using Quality-Inspired Dashboards to Track Patient Engagement1:45 PM — 2:45 PM
New Approaches, Novel Endpoints, and Next-Generation Trials2:00 PM — 2:30 PM
On the Soapbox: Right to Try3:00 PM — 4:15 PM
Bayesian Application in Small-Sized Clinical Trials3:00 PM — 4:15 PM
Courageous Leadership3:00 PM — 4:15 PM
Development of Microbiome-Derived Therapeutics3:00 PM — 4:00 PM
eSource: The Road to Real World Evidence – Are We There Yet?3:00 PM — 4:00 PM
Facilitating Nonclinical Data-Sharing and Access Across the Industry3:00 PM — 4:00 PM
FDA Expectations for Demonstration of Interchangeability3:00 PM — 4:15 PM
How Inspection-Ready is Your Organization?3:00 PM — 4:30 PM
International Regulatory Convergence3:00 PM — 4:15 PM
Novel Approaches to Pharmacovigilance Collaboration3:00 PM — 4:15 PM
Real World Evidence for Value and Access3:00 PM — 4:15 PM
TFDA Town Hall3:00 PM — 4:15 PM
The Evolving Biosimilars Landscape: A Medical Affairs Perspective8:00 AM — 9:15 AM
Artificial Intelligence: The Future of Regulatory Affairs8:00 AM — 9:15 AM
Building Your Brand8:00 AM — 9:15 AM
FDA Data Standards Update8:00 AM — 9:15 AM
Generic Drug Products: Comparison of Safety Profile With Branded Cousin8:00 AM — 9:15 AM
Global Regulatory Strategies for Biosimilars8:00 AM — 9:00 AM
Oversight in the Era of E6 (R2)8:00 AM — 9:15 AM
Pediatric and Rare Disease Drug Development8:00 AM — 9:15 AM
Update on Collaboration and Trends in Global Companion Diagnostics9:15 AM — 9:45 AM
FDA Warning Letters on Data Integrity9:30 AM — 10:30 AM
Brexit: Practical Real-World Solution Planning9:45 AM — 10:15 AM
On the Soapbox: Blockchain and Genomics10:00 AM — 10:30 AM
Building a Dynamic Presentation: Rethinking Audience Engagement10:30 AM — 11:45 AM
Biosimilars: Demonstrating Structural and Functional Similarity10:30 AM — 11:45 AM
Common Data Model Harmonization for Evidence Generation10:30 AM — 11:30 AM
Expanded Access: Where Are We Now?10:30 AM — 11:45 AM
Generic Drug Town Hall10:30 AM — 11:30 AM
Global Clinical Trials: Lessons in Effective Execution10:30 AM — 12:00 PM
Global Perspectives on Patient Engagement10:30 AM — 11:45 AM
Mobile Reported Outcomes: A Forum on Patient and Caregiver Assessments10:30 AM — 11:45 AM
Personalized Medicine Approaches During Early-Phase Clinical Research10:30 AM — 11:45 AM
Regulators’ Utilization of Real-World Data in Pharmacovigilance Activities10:30 AM — 11:45 AM
The Adventures of Patient Experience in Drug Development10:30 AM — 11:45 AM
Time-to-Event Analysis in Clinical Trials10:30 AM — 12:00 PM
Unmet Medical Need: Can the Stakeholders Align? Progress to Date12:10 PM — 12:55 PM
IQVIA Innovation Theater: Real World Evidence to Enhance Drug Development2:00 PM — 3:15 PM
Digitizing a Patient-Focused Clinical Trial Experience2:00 PM — 3:30 PM
Future of PharmaTech2:00 PM — 3:15 PM
Globalizing and Regionalizing Medical Information Contact Centers2:00 PM — 3:15 PM
ICH M9 BCS-Based Biowaivers2:00 PM — 3:15 PM
Navigating the Regulatory Landscape of Drug-Device Combination Products2:00 PM — 3:00 PM
Optimizing Clinical Development With Adaptive Trial Designs2:00 PM — 3:15 PM
Project Management Throwdown: How Not to Get Chopped2:00 PM — 3:15 PM
Risk Management: New Directions2:00 PM — 3:15 PM
User-Friendly Tools for Study Planning and Analysis2:15 PM — 3:15 PM
Avoiding Rejection on your "First Date" with EMA Policy 00703:30 PM — 4:00 PM
DIA Insights: Latest Global Healthcare Coverage and How to Get Published3:30 PM — 4:15 PM
LinkedIn Profile Exchange Review3:40 PM — 4:10 PM
Veeva Systems Innovation Theater: Simplifying Variation Management4:15 PM — 5:30 PM
Debunking Decentralized Trials: Sharing Breakthroughs and Deal Breakers4:15 PM — 5:30 PM
Electronic Submissions Demystified4:15 PM — 5:30 PM
Evolving Roles and Responsibilities for Medical Affairs Professionals4:15 PM — 5:30 PM
Future of Endpoints4:15 PM — 5:30 PM
Gene Therapy: Advances in Translating Technology4:15 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 — 5:30 PM
Patient Engagement in Pharmacovigilance4:15 PM — 5:30 PM
Pharmacovigilance: No Longer Going it Alone4:15 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 Experience4:15 PM — 5:15 PM
Sustainable Healthcare Funding8:00 AM — 9:15 AM
Automation in Pharmacovigilance: Doing More with Less8:00 AM — 9:15 AM
Becoming Highly Self-Aware: Leading in the Midst of Ambiguity8:00 AM — 9:15 AM
Can I Implement That Now? Efficiently Managing Post-Approval CMC Changes8:00 AM — 9:15 AM
Evolution and Harmonization of First-in-Human Guidelines8:00 AM — 9:15 AM
Global Rare Disease Town Hall8:00 AM — 9:15 AM
Harnessing the Power of Data and Analytics to Enhance Quality8:00 AM — 9:00 AM
Operationalizing Real World Evidence and Value8:00 AM — 9:15 AM
Opportunities for Efficient and Innovative Study Designs8:00 AM — 9:00 AM
PowerUp: Career Transforming Moments9:15 AM — 9:45 AM
New Resource from the DIA Interdisciplinary Disclosure Working Group10:00 AM — 10:30 AM
Getting the Questions Right10:30 AM — 11:45 AM
Artificial Intelligence: Robots Taking Over Clinical Research10:30 AM — 11:45 AM
Biosimilar Interchangeability: A Global Perspective10:30 AM — 11:45 AM
Clinical Data: Let’s Get to the Source and Streamline it to the End10:30 AM — 11:45 AM
Collaboration Across the Medical Affairs Ecosystem to Advance Patient Care10:30 AM — 11:45 AM
Determining Data Integrity: Decoding the Impact of Inspectional Observations10:30 AM — 11:45 AM
Harmonization Beyond ICH10:30 AM — 11:45 AM
Innovative Visualization Approaches10:30 AM — 11:45 AM
New FDA Draft Guidance on Part 11 in Clinical Investigations10:30 AM — 11:45 AM
Rebuilding or Building a Research Site in the Year 202010:30 AM — 11:45 AM
Sex Considerations in the FDA Drug Review Pipeline: The Where, When, and How10:30 AM — 11:30 AM
Streamlining Vendor Reconciliation10:30 AM — 12:00 PM
Unmet Medical Need: Path Forward – Creating a Commonly Agreed Criteria Globally10:30 AM — 11:45 AM
You've Got Data #now what?12:00 PM — 12:30 PM
Making Better Portfolio Prioritization Decisions12:45 PM — 1:15 PM
Moving Forward with the EU Vigil: The Patient Contact in Pharmacovigilance1:10 PM — 1:55 PM
IQVIA Innovation Theater: The Digital Future is Now1:15 PM — 2:00 PM
The Worst Co-Worker on the Block1:30 PM — 2:00 PM
Difficult Conversations2:00 PM — 3:00 PM
A New Way of Authoring and Reviewing Documents for Clinical Development2:00 PM — 3:00 PM
AdPromo: Assessing Risk in the Current Regulatory Environment2:00 PM — 3:15 PM
Courageous Hiring2:00 PM — 3:00 PM
Do the Evolution: The Future Role of Clinical Data Management2:00 PM — 3:15 PM
Engaging the Rare Disease Community to Design Clinical Trials2:00 PM — 3:15 PM
Gene Therapy Clinical Trials: Current Challenges2:00 PM — 3:15 PM
IMEDS: A Collaboration Based on the FDA's Sentinel Initiative2:00 PM — 3:15 PM
Implementation of eConsent and Other Digital Clinical Trial Innovations2:00 PM — 3:15 PM
Modernization and Harmonization of Inspectional Approaches2:00 PM — 3:15 PM
PMDA Town Hall2:00 PM — 3:15 PM
Real Life Strategies for Collaborative Stakeholder Management2:00 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 Endeavors4:00 PM — 5:15 PM
Artificial Intelligence: A Disruptive Journey for Pharmacovigilance4:00 PM — 5:15 PM
Bring Your Own Device ePRO: Hold the Relish, or No Holds Barred?4:00 PM — 5:15 PM
Evolving CDISC Standards and Technologies4:00 PM — 5:15 PM
FUNdamentals of Project Management4:00 PM — 5:15 PM
How to De-Risk Alliances for Success4:00 PM — 5:15 PM
Innovations in Managing Global Clinical Supplies4:00 PM — 5:15 PM
Patient Observation Versus Patient Engagement: Optimizing Development4:00 PM — 5:15 PM
Special Population Study Challenges4:00 PM — 5:00 PM
The Impact of Cell and Gene Therapy on the Payer System4:00 PM — 5:15 PM
Think Like a Regulator: Evaluating Trial Integrity4:00 PM — 5:00 PM
Update on BREXIT9:00 AM — 10:30 AM
EMA/FDA Question Time9:00 AM — 10:00 AM
Innovative Funding Models for Novel Therapeutics9:00 AM — 10:15 AM
Putting Patient Experience First9:00 AM — 10:15 AM
Regulatory and Industry Perspectives on the Common Protocol Template9:00 AM — 10:30 AM
Unmet Medical Need: What Did We Create Together and Where to Take It?10:45 AM — 12:00 PM
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