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DIA 2018 Global Annual Meeting

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7:00am EDT

Coffee and Light Refreshments North Lobby Attendee, Speaker, and Exhibitor Registration North Lobby

8:00am EDT

#317: Operationalizing Real World Evidence and Value Room 257AB #319: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Pharmacovigilance: No Longer Going It Alone Community Zone NE Lobby #320: DIA Patient Engagement Community Round Table Discussion: Reaching the Underserved - Methods to Ensure Diversity and Inclusion for Patient Research, Clinical Trials, and Advisory Panels Community Zone NE Lobby #321: PowerUp: Career Transforming Moments Room 157AB #301: Automation in Pharmacovigilance: Doing More With Less Room 253C #302: Risk Communication and Patient Safety: Recent Learnings and New Approaches Room 253AB #303: Regulatory and Ethical Considerations with Placebo Administration Using a Central Venous Access Device in a Pediatric Trial Room 258C #304: Data and Quality Approaches to Informing Global Investigative Site Selection Room 258AB #305: Building a Roadmap to the Implementation of the Risk-Based Monitoring Process: Facilitating the Perspectives of All Stakeholders Room 254AB #306: phactMI: A Collaborative Approach to Advancing the Practice of Medical Information and Enabling Innovative Customer Solutions Room 210C #307: Maintaining Patient Engagement in the Development of Patient-Reported Outcome (PRO) Measures Room 153ABC #308: How Do Patients and Other Multi-Disciplinary Stakeholders Collaborate to Develop Patient Registries which Accelerate Research? Room 151AB #309: Evolution and Harmonization of First-in-Human Guidelines Room 156ABC #310: Becoming Highly Self-Aware: Leading in the Midst of Ambiguity Room 252AB #311: Harnessing the Power of Data and Analytics to Enhance Quality Room 205C #312: Harmonizing Regulatory Science Through the International Council for Harmonisation (ICH) Room 206AB #313: Global Rare Disease Town Hall Room 205AB #314: What Can We Say About Combination Products? Labeling, Advertising and Promotion of Combination Products Room 204AB #315: Can I Implement That Now? Efficiently Managing Post-Approval CMC Changes Room 208 #316: Opportunities for Efficient and Innovative Study Designs Room 256 #318: Value-Based Assessment and Contracting: What Needs to be Done to Make it a Best Practice? Room 210AB

9:00am EDT

Coffee Break Exhibit Hall Exhibit Hall Open Exhibit Hall Professional Poster Session 2 Posters Exhibit Hall

9:15am EDT

#322: New Resource from the DIA Interdisciplinary Disclosure Working Group Content Hub NE Lobby

9:30am EDT

#323: Good Things Come in Small Packages: Product Development Strategies for Small Companies E and E Exhibit Hall #324: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Patient Engagement in Pharmacovigilance Community Zone NE Lobby #325: 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 Community Zone NE Lobby

9:45am EDT

#326: ArisGlobal Innovation Theater: A Regulatory Perspective - How Cognitive E-2-E Pharma Platforms can Transform Productivity in Pharma - Introducing LifeSphere from Clinical to Regulatory Theater 1 Exhibit Hall #327: SAS Institute, JMP Division Innovation Theater: RECIST Criteria and Their Impact on Safety and Efficacy Reporting in Oncology Studies Theater 2 Exhibit Hall

10:00am EDT

#328: Getting the Questions Right Content Hub NE Lobby

10:30am EDT

#333: Streamlining Vendor Reconciliation Room 209 #337: Balancing Regulatory, Medical, and Operational Pillars to Get Pediatric Trials Done Globally Room 156ABC #329: 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? Room 253AB #330: Artificial Intelligence: Robots Taking Over Clinical Research Room 253C #331: Rebuilding or Building a Research Site in the Year 2020 Room 254AB #332: Clinical Data: Let’s Get to the Source and Streamline it to the End Room 208 #335: Collaboration Across the Medical Affairs Ecosystem to Advance Patient Care Room 257AB #336: Addressing the Elephant in the Room: A Hard Look at Metrics, Legal, Payers, and Other Leading Obstacles Facing the Sustainability of Patient Engagement Room 153ABC #338: You've Got Data #now what? Room 157AB #339: Determining Data Integrity: Decoding the Impact of Inspectional Observations Room 258AB #340: Harmonization Beyond ICH Room 206AB #341: New FDA Draft Guidance on Part 11 in Clinical Investigations Room 204AB #342: Sex Considerations in the FDA Drug Review Pipeline: The Where, When, and How Room 205C #343: Innovative Visualization Approaches Room 256 #344: Biosimilar Interchangeability: A Global Perspective Room 205AB #334: Clinical Trial Disclosure: Learnings from EMA Policy 0070, NIH Final Rule, and FDA’s Clinical Data Summary Pilot Program Room 210C #345: Unmet Medical Need: Path Forward – Creating a Commonly Agreed Criteria Globally Room 252AB #346: Precision Medicine, Gene Editing, and Gene Therapy: Current Status and Regulatory Challenges of Integrating Genetic Medicine into Clinical Care Room 210AB

11:30am EDT

Luncheon Service Exhibit Hall

12:00pm EDT

#348: Making Better Portfolio Prioritization Decisions Content Hub NE Lobby #347: Just the Right Tool: ICH E6 (R2) Compliance Tools for Small to Mid-Size Companies E and E Exhibit Hall

12:10pm EDT

#349: ZS Associates Innovation Theater: Building an RWE Bridge from Population Health to Personalized Medicine Theater 1 Exhibit Hall #350: Salesforce Innovation Theater: Accelerate R&D Innovation with Salesforce for Life Sciences Theater 2 Exhibit Hall

12:45pm EDT

#351: Moving Forward with the EU Vigil: The Patient Contact in Pharmacovigilance Content Hub NE Lobby

1:00pm EDT

#352: DIA Clinical Pharmacology Community Round Table Discussion: Evolution and Harmonization of First-in-Human Guidelines Community Zone NE Lobby #353: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Automation in Pharmacovigilance - Doing More With Less Community Zone NE Lobby

1:10pm EDT

#355: PAREXEL International Innovation Theater: The Application of Mobile Health Across the Clinical Development Spectrum: 5 Critical Insights Theater 2 Exhibit Hall #354: IQVIA Innovation Theater: The Digital Future is Now Theater 1 Exhibit Hall

1:15pm EDT

#356: The Worst Co-Worker on the Block E and E Exhibit Hall

1:30pm EDT

#357: Difficult Conversations Content Hub NE Lobby

2:00pm EDT

#361: A New Way of Authoring and Reviewing Documents for Clinical Development Room 258C #362: Do the Evolution: The Future Role of Clinical Data Management Room 209 #372: AdPromo: Assessing Risk in the Current Regulatory Environment Room 206AB #358: Expedited E2B Safety Reporting in Interventional Clinical Trials: Convergence of Global Expectations? Room 253AB #359: IMEDS: A Collaboration Based on the FDA's Sentinel Initiative Room 253C #360: Implementation of eConsent and Other Digital Clinical Trial Innovations Room 258AB #363: Innovative and Effective Authoring Strategies to Facilitate Accelerated Regulatory Submissions Room 157AB #364: Achieving Customer Centricity to Advance Patient Care Through Innovative Communication Channels Room 210C #365: Engaging the Rare Disease Community to Design Clinical Trials Room 151AB #366: Gene Therapy Clinical Trials: Current Challenges Room 156ABC #367: Real Life Strategies for Collaborative Stakeholder Management Room 252AB #368: Predicting Future Generic Drug Competition: Powering Strategic Planning Using Quantitative Methods and Modeling Room 153ABC #369: Virtual Audits: Do They Achieve the Objective? Room 257AB #370: Clinical Outcome Assessments (COA) Endpoints for Use in Rare and Ultra-Rare Disease Clinical Trials Room 204AB #371: What's New in Health Canada: Updates and New Endeavors Room 205C #373: PMDA Town Hall Room 205AB #374: Modernization and Harmonization of Inspectional Approaches Room 208 #375: Statistical Challenges in Assessing Drugs’ Efficacy by Utilizing Biomarker Endpoints Room 256 #376: Courageous Hiring Room 254AB

2:15pm EDT

#377: First-In-Human Studies: An Examination of the Evolving Regulatory and Clinical Practices to Ensure Subject Safety Content Hub NE Lobby

3:00pm EDT

#378: DIA Devices and Diagnostics Community Round Table Discussion: What Can We Say About Combination Products? Labeling, Advertising and Promotion of Combination Products Community Zone NE Lobby #379: 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... Community Zone NE Lobby Refreshment Break Exhibit Hall

3:15pm EDT

#380: Use of New Data Sources and Evidence Types for Regulatory Decision Making in Drug Development E and E Exhibit Hall

3:25pm EDT

#380B: Tata Consulting Services Innovation Theater: TCS' Life Sciences Platforms: Disrupt Clinical Research in a Digital World! Theater 2 Exhibit Hall

3:30pm EDT

#381: Project Management’s Role in Developing and Securing Governance Approval of a Drug Development Program Strategy Content Hub NE Lobby

4:00pm EDT

#394: Update on BREXIT Room 205AB #398: The Impact of Cell and Gene Therapy on the Payer System Room 204AB #382: Artificial Intelligence: A Disruptive Journey for Pharmacovigilance Room 253AB #383: Safe Use and Prescribing of Opioid Medications: An In-Depth Look at the Strategies and Their Evaluation Room 253C #384: Innovations in Managing Global Clinical Supplies Room 258AB #385: Does Sourcing Strategy Matter? Executives Debate the Influence of Outsourcing Model on Clinical Trial Execution Room 258C #386: Bring Your Own Device ePRO: Hold the Relish, or No Holds Barred? Room 257AB #387: Evolving CDISC Standards and Technologies Room 208 #388: Using Patient-Centric Outcomes to Engage Patients in Shared Treatment Decision Making Room 210C #389: Patient Observation Versus Patient Engagement: Optimizing Development Room 151AB #390: Special Population Study Challenges Room 156ABC #391: How to De-Risk Alliances for Success Room 209 #392: FUNdamentals of Project Management Room 153ABC #393: Think Like a Regulator: Evaluating Trial Integrity Room 252AB #395: PDUFA VI: Improving Transparency and Accountability of Electronic Submission and Data Standards Activities Room 205C #396: Current and Future Perspective on Mutual Recognition, Work Sharing, and Global Regulatory Convergence Room 254AB #397: Design and Statistical Considerations for Real World Evidence to Support Regulatory Decision Making Room 256