Agenda
9:00 AM — 12:30 PM
#21: Basics of European Medical Device Regulation9:00 AM — 12:30 PM
#22: Protocol Co-Design with Patients and Advocates9:00 AM — 12:30 PM
#23: Preparing for a US FDA Advisory Committee Meeting9:00 AM — 12:30 PM
#24: Data Visualization in the Life Sciences9:00 AM — 5:00 PM
#40: Interdisciplinary Safety Evaluation During Product Development9:00 AM — 5:00 PM
#43: Back to the Future: Combination Products in the 21st Century11:00 AM — 12:30 PM
Forum for Students and Emerging Professionals12:45 PM — 2:00 PM
Student Networking Luncheon1:30 PM — 5:00 PM
#30: Machine Learning in Pharmacovigilance1:30 PM — 5:00 PM
#33: European Regulatory Meetings: How Best to Prepare and Perform2:30 PM — 3:30 PM
Self-Branding for Social Media3:45 PM — 5:00 PM
Effective Networking: Know Yourself3:45 PM — 5:00 PM
Student and Young Professional Resume Workshop7:00 AM — 7:45 AM
Annual Meeting Orientation8:00 AM — 10:00 AM
Opening Plenary, Keynote, and DIAmond Session10:10 AM — 10:40 AM
Modernizing Data Review in Drug Development with R Shiny10:15 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 Safety11:00 AM — 12:00 PM
Emerging Technologies in Clinical Research11:00 AM — 12:00 PM
FDA Payer Communication Guidance, Twenty Years in the Making: Now What?11:00 AM — 12:00 PM
Innovation in Enrollment, Recruitment, and Retention11:00 AM — 12:00 PM
International Regulatory Convergence11:00 AM — 12:00 PM
Making Value-Based Contracting Stick11:00 AM — 12:00 PM
Moving Forward in EU Pharmacovigilance12:15 PM — 1:00 PM
ICH E2B IND Safety Reporting to FDA Adverse Event Reporting System (FAERS)1:00 PM — 1:30 PM
Separating the Hype from Reality in Pharmacovigilance Automation1:15 PM — 2:15 PM
Round Table Discussion: Emerging Technologies in Clinical Research2:15 PM — 3:15 PM
Blockchain in Clinical Trials Demo: Truth or Dare2:15 PM — 3:15 PM
Communications with Regulators Beyond Formal Meetings2:15 PM — 3:15 PM
Emerging Technology to Improve Sponsor-Site Interactions2:15 PM — 3:15 PM
Hype Versus Reality: Artificial Intelligence and Drug Development2:15 PM — 3:15 PM
Interpretation of New Pharmacovigilance Regulations: Key Insights2:15 PM — 3:15 PM
Ready or Not: Business Continuity Planning2:15 PM — 3:15 PM
TFDA Town Hall: Focus on Regenerative Medicine2:15 PM — 3:15 PM
Update from Health Canada: The Health Protection Branch2:15 PM — 3:15 PM
Update on ICH Quality Topics3:30 PM — 4:30 PM
Clinical Research in Emerging Regions3:30 PM — 4:30 PM
Community Meet Up: Forum of Pharmacovigilance Quality Heads3:30 PM — 4:30 PM
Drug Development Tools in a Digital Era3:30 PM — 4:30 PM
How Statistics Can Help Improve Data Quality: ICH E6 R23:30 PM — 4:30 PM
Making Early Access for Patients Happen3:30 PM — 4:30 PM
Making Trials Work for Special Populations3:30 PM — 4:30 PM
New Communication Channels for Medical Information3:30 PM — 4:30 PM
Strategic Integration: Is Anyone Getting it Right?3:30 PM — 4:30 PM
The Courage of Career Transitions3:30 PM — 4:30 PM
Understanding the Data Journey In Virtual Trials3:30 PM — 4:30 PM
Updates on China Regulatory Reform4:45 PM — 5:15 PM
Deloitte Consulting Innovation Theater: Reimagining Patient Safety5:15 PM — 6:15 PM
Community Meet Up: Patient Engagement5:15 PM — 6:00 PM
Data Analytics Use in Quality Processes5:30 PM — 6:00 PM
Syneos Health Innovation Theater: Dialing In the Optimal FSP Solution6:00 PM — 7:00 PM
Community Meet Up: Statistics Community Meet and Greet7:30 AM — 8:00 AM
DIAlogue Session 1: Welcome to Day 2 of DIA 20197:30 AM — 8:00 AM
Talent Show8:00 AM — 9:15 AM
eConsent Done Right8:00 AM — 9:15 AM
Emerging Issues in CRISPR and Gene Editing Symposium8:00 AM — 9:15 AM
Increasing Personal Resilience To Manage Change8:00 AM — 9:15 AM
Pharmacovigilance Reporting and Quality8:00 AM — 9:15 AM
Protocol Developments of the Future8:00 AM — 9:15 AM
Quality Considerations for Complex Generics8:00 AM — 9:15 AM
Real World Data to Real World Evidence9:15 AM — 9:45 AM
Getting the Question Right (GTQR) with Interdisciplinary Collaboration9:45 AM — 10:15 AM
Covance Innovation Theater: Fixing the Patient Recruitment "Leaky Funnel"10:30 AM — 11:30 AM
An Industry Collaboration on Pharmacovigilance Analytics10:30 AM — 11:30 AM
Artificial Intelligence Enhanced Data Analytics for Clinical Trials10:30 AM — 11:30 AM
Build and Leverage Your Networks to Influence Stakeholders10:30 AM — 11:30 AM
Emerging Safety Challenges in New Oncology Treatments10:30 AM — 11:30 AM
Outcomes, Endpoints, and Methods Supporting Oncology and Alzheimer Therapies10:30 AM — 11:30 AM
PMDA Town Hall10:30 AM — 11:30 AM
Pregnancy, Breastfeeding, Childcare, Oh My! Finding a Balance for New Moms10:30 AM — 11:30 AM
Quality and Compliance Management in Medical Information/Medical Affairs10:30 AM — 11:30 AM
The Future of Combination Products in the EU10:30 AM — 11:30 AM
The Rare Disease Experience in Clinical Trials10:30 AM — 11:30 AM
Where Quality Meets Safety and Efficacy: A Conversation with CMC Experts11:40 AM — 12:25 PM
Veeva Systems Innovation Theater: Shortening Database Builds by 40-60%2:00 PM — 3:15 PM
Clinical Trial Diversity: Moving from Admiring the Problem to Solving it2:00 PM — 3:00 PM
DIAlogue Session 2: Publications Meet Up - Inside the DIA Journal2:00 PM — 3:15 PM
Driving Complex Generics to Approval: What are the Keys to Success2:00 PM — 3:15 PM
Electronic Systems: Are Yours Fit for Purpose?2:00 PM — 3:15 PM
FDA Data Standards Update2:00 PM — 3:15 PM
Master Protocols: Applications in Oncology2:00 PM — 3:00 PM
Pharma Powered by the Digital2:00 PM — 3:15 PM
Presentations as Listeners Like Them: How to Tailor Messaging2:00 PM — 3:15 PM
Wearables and Patient Technologies Utilized in Clinical Trials2:00 PM — 3:15 PM
Where Quality Meets Safety and Efficacy: An Interactive Experience3:15 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 Regions3:30 PM — 4:00 PM
3:30 PM — 4:00 PM
How to Write a Compelling Poster Abstract4:15 PM — 5:30 PM
Clinical Safety Assessment: What’s a Statistician Got to Do with It?4:15 PM — 5:30 PM
Let's Talk Risk-Based Monitoring4:15 PM — 5:30 PM
Prescription Drug Labeling: New Guidances from the US FDA4:15 PM — 5:30 PM
Public and Regulatory Response To Drug Pricing Concerns4:15 PM — 5:30 PM
The Changing Landscape of Medical Affairs: Are We Prepared For 2020?4:15 PM — 5:30 PM
Virtual Clinical Trials5:00 PM — 6:00 PM
Community Meet Up: Medical Writing Community Meet and Greet5:00 PM — 6:00 PM
Community Meet Up: Women in Life Sciences7:30 AM — 8:00 AM
Talent Show8:00 AM — 9:15 AM
Demystifying Technology Selection in Mobile Clinical Trials8:00 AM — 9:15 AM
How to Solve the Problem of Access for Rare Diseases8:00 AM — 9:15 AM
Implementation of Innovative and Adaptive Designs in Clinical Trials8:00 AM — 9:15 AM
Improving Trial Quality by Better Preparing Site Teams8:00 AM — 9:15 AM
Measuring and Assessing Product Manufacturing Quality8:00 AM — 9:15 AM
Methods for Integrating EHR Data into EDC and eSource Databases8:00 AM — 9:15 AM
Operationalizing Master Protocols8:00 AM — 9:15 AM
Project Planning 101: Turning Strategy into Execution8:00 AM — 9:15 AM
So Much Data, So Little Time: Hot Topics in Benefit-Risk Assessment8:00 AM — 9:15 AM
Triple-s (3S) Smart Safety Surveillance9:15 AM — 9:45 AM
Considering Consulting? The Good, the Bad, the Ugly, and the Profitable!9:30 AM — 10:30 AM
Round Table Discussion: Real World Data to Real World Evidence10:00 AM — 10:30 AM
2020 and Beyond, Data Capture Across Systems, Functions, and Modalities10:30 AM — 11:30 AM
Achieving High Performance Through Emotional Intelligence10:30 AM — 11:30 AM
Digital Risk Minimization: The “Next Generation” Risk Management Tools10:30 AM — 11:30 AM
Digital Technology Advances Labeling Management and Patient Access10:30 AM — 11:30 AM
Efficient Preparation of Global CMC Dossiers10:30 AM — 11:30 AM
eSource Adoption: Where We Are - Our Experiences from eSource Implementation10:30 AM — 11:30 AM
Global Clinical Trials: Make Them Really Global and Involve Africa10:30 AM — 11:30 AM
Hot Topics in Quality and Regulatory Affairs for Combination Products10:30 AM — 11:30 AM
Pediatric Plans: The Challenges Between Regulations and Reality10:30 AM — 11:30 AM
Risk-Based Monitoring: Best Practice Today and Technology for Tomorrow10:30 AM — 11:30 AM
The Evolving Gene Therapy Regulatory Framework: A Brave New World10:30 AM — 11:30 AM
Understanding and Exploring Elements of a Patient-Focused Product Launch10:30 AM — 11:30 AM
When is Real World Evidence Ready for Prime Time?11:40 AM — 12:25 PM
ZS Innovation Theater: Designing With Confidence12:30 PM — 1:00 PM
Project Managing Your Own Leadership Journey12:30 PM — 1:30 PM
Regulatory Affairs Governance: Benchmarking and Sharing of Best Practices12:40 PM — 1:25 PM
IQVIA Innovation Theater: The Digital Patient Experience1:15 PM — 1:45 PM
The Current and Future State of RIM2:00 PM — 3:15 PM
Advancing Value and Access With Technology2:00 PM — 3:15 PM
Challenges and Opportunities in Product Quality: Lifecycle Management2:00 PM — 3:15 PM
Effective Portfolio Management of Assets Across an Organization2:00 PM — 3:15 PM
Global Rare Disease Town Hall2:00 PM — 3:15 PM
Identification of Medicinal Products: FDA's Perspective and Approach2:00 PM — 3:15 PM
User-Fee Programs Myth Busting: General Financial Principles Explained3:15 PM — 4:15 PM
Round Table Discussion: Master Protocols: Applications in Oncology4:15 PM — 5:30 PM
A New Path Forward for Using Decentralized Clinical Trials4:15 PM — 5:30 PM
Case Studies in Resolving Quality Issues4:15 PM — 5:30 PM
Challenges to Access: Bringing Payers to the Table4:15 PM — 5:30 PM
From Trials to Real World: How Safety Protocols Impact REMS4:15 PM — 5:30 PM
Next-Generation Approaches for Developing Narratives4:15 PM — 5:30 PM
PowerUp: Stories of Career Transforming Moments4:15 PM — 5:30 PM
Real World Data Quality for Regulatory Decision-Making4:15 PM — 5:30 PM
Setting the Stage for Effective Stakeholder Collaboration8:30 AM — 9:00 AM
Manage Risks and Enhance Engagement Through Digital Approaches9:00 AM — 10:15 AM
Case Studies From FDA and MHRA: Good Clinical Practices9:00 AM — 10:15 AM
Electronic Submissions Update9:00 AM — 10:15 AM
eSource and the Sites: Have They Bonded?9:00 AM — 10:15 AM
FDA Botanicals9:00 AM — 10:15 AM
Keeping Up with FDA and EMA Collaborations: Question Time9:00 AM — 10:15 AM
Recent CMC Changes in Emerging Regulatory Agencies9:00 AM — 10:15 AM
Successes and Challenges in Pharmacovigilance for Biologics and Biosimilars10:45 AM — 12:00 PM
FDA Town HallHave an account?