DIA 2018 Global Annual Meeting has ended

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DIA 2018 Global Annual Meeting

11:00am EDT

#105: Cardiac Safety in Drug Development and the Critical Role of Public-Private Partnerships: The Cardiac Safety Research Consortium Model Room 253AB #107: The Metamorphosis of Clinical Trials: Evolving Roles of Stakeholders in Digital Trials Room 257AB #108: From Patients and Advocacy Groups to Operations and Beyond: Obtaining and Incorporating Input from Stakeholders in Protocol Design Room 258AB #115: Regenerative Medicine Advanced Therapies: Facilitating Product Development and Approval Room 156ABC #109: The Who, What, How, When, and Why of Using Mobile Technology in Clinical Trials Room 258C #110: Using Fast Healthcare Interoperability Resources (FHIR®) for Clinical Research Room 208 #114: A Hot Debate: Perspectives on Benefit and Risk From Patients Across Diseases Room 153ABC #121: Use of Historical Information in Clinical Trial Design Room 256

3:00pm EDT

#141: eSource: The Road to Real World Evidence – Are We There Yet? Room 257AB #142: Mobile Accelerometry in Clinical Trials: Potential Applications and Meaningful Outcomes Room 258AB #143: Applying Artificial Intelligence, Machine Language, Natural Language Processing, and Predictive Models in Clinical Trials to Deliver Value to Stakeholders Room 209 #145: A New Ecosystem: The Nature of Relationships Between Patient Advocacy Groups and Sponsors Room 153ABC #149: A Quality-by-Design Approach to Trial Design and Conduct: Case Studies from the Clinical Trials Transformation Initiative Room 205C #154: Bayesian Application in Small-Sized Clinical Trials Room 256

8:00am EDT

#202: Quantifying the Impact of Credentialed Clinical Research Site Professionals on Clinical Trial Conduct Quality Room 257AB #203: Utilizing and Understanding Real World Evidence Solutions to Efficiently Recruit the Most Appropriate Patients and Sites for Clinical Trials Room 258AB #215: Pediatric and Rare Disease Drug Development Room 256

10:30am EDT

#228: Global Clinical Trials: Lessons in Effective Execution Room 258AB #227: Digital Data Flow from Protocol to Report: TransCelerate’s Common Protocol Template and the Art of the Possible Room 257AB #229: Mobile Reported Outcomes: A Forum on Patient and Caregiver Assessments Room 258C #234: Personalized Medicine Approaches During Early-Phase Clinical Research Room 156ABC #241: Time-to-Event Analysis in Clinical Trials Room 256

2:00pm EDT

#255: Use of Electronic Health Records (EHRs) as eSource in Clinical Investigations Room 208 #260: Optimizing Clinical Development With Adaptive Trial Designs Room 156ABC #252: Do the End(point)s Justify the Means? A Peak at Endpoints Accepted by FDA With an Eye Towards Mobile Technology Collection Room 257AB #253: Digitizing a Patient-Focused Clinical Trial Experience Room 258AB #254: Risk-Based Monitoring for Master Protocol Study: A Dilemma and Possible Ways to Go Room 258C #266: User-Friendly Tools for Study Planning and Analysis Room 256

4:15pm EDT

#284: Using Advocacy Partnerships to Improve Real World Evidence in Clinical Trials Room 151AB #279: Redefining the Site Investigator's Experience Room 153ABC #280: Debunking Decentralized Trials: Sharing Breakthroughs and Deal Breakers Room 254AB #281: Future of Endpoints Room 258C #282: Building up Efficiencies, Breaking Down Barriers: Using Mobile Technology for Data Capture in Clinical Trials Room 209 #285: Gene Therapy: Advances in Translating Technology Room 156ABC #292: Complex Innovative Designs and Model-Informed Drug Development Related: PDUFA VI Pilot Programs Room 256

8:00am EDT

#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 #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 #316: Opportunities for Efficient and Innovative Study Designs Room 256

10:30am EDT

#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

2:00pm EDT

#361: A New Way of Authoring and Reviewing Documents for Clinical Development Room 258C #358: Expedited E2B Safety Reporting in Interventional Clinical Trials: Convergence of Global Expectations? Room 253AB #360: Implementation of eConsent and Other Digital Clinical Trial Innovations Room 258AB #364: Achieving Customer Centricity to Advance Patient Care Through Innovative Communication Channels Room 210C #366: Gene Therapy Clinical Trials: Current Challenges Room 156ABC #375: Statistical Challenges in Assessing Drugs’ Efficacy by Utilizing Biomarker Endpoints Room 256

4:00pm EDT

#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 #390: Special Population Study Challenges Room 156ABC #397: Design and Statistical Considerations for Real World Evidence to Support Regulatory Decision Making Room 256

9:00am EDT

#408: Innovative Funding Models for Novel Therapeutics Room 206AB #411: Regulatory and Industry Perspectives on the Common Protocol Template Room 253C #413: The Correlation Between Patient-Reported Outcomes and Clinician-Reported Outcomes Room 254AB