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DIA 2018 Global Annual Meeting

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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 #207: Novel Approaches for Accessing the CNS: Nonclinical and Clinical Challenges Room 156ABC #209: Oversight in the Era of E6 (R2) Room 205C #204: FDA Data Standards Update Room 209 #205: Best Practices for Implementing Lay Summaries and Communicating Results to Patients Room 210C #212: Global Regulatory Strategies for Biosimilars Room 204AB #214: CMC Challenges for Breakthrough Therapies and Other Worldwide Accelerated Approval Programs Room 253C #215: Pediatric and Rare Disease Drug Development Room 256 #216: Early HTA Scientific Advice: Does it Improve Internal Company Decision-Making and Ensure Predictability of HTA Outcome? Room 258C

9:15am EDT

#219: FDA Warning Letters on Data Integrity Content Hub NE Lobby

9:45am EDT

#223A: On the Soapbox: Blockchain and Genomics Room 157AB #223B: Covance Innovation Theater: Case Study - Driving Clinical Transformation Through a Next-Generation of Data Integration and Analytic Technologies with a GlaxoSmithKline-Covance Partnership Theater 1 Exhibit Hall #224: Veeva Systems Innovation Theater: Global Industry Report - New Findings from the 2018 Unified Clinical Operations Survey Theater 2 Exhibit Hall

10:00am EDT

#225: Building a Dynamic Presentation: Rethinking Audience Engagement Content Hub NE Lobby

10:30am EDT

#228: Global Clinical Trials: Lessons in Effective Execution Room 258AB #231: Automation with Intelligence: From Standard-Based Solution to Metadata-Driven Automation Room 209 #237: Expanded Access: Where Are We Now? Room 206AB #226: Regulators’ Utilization of Real-World Data in Pharmacovigilance Activities Room 253AB #230: Common Data Model Harmonization for Evidence Generation Room 208 #232: Digital Data and New Technologies to Drive Customer Impact in Medical Affairs, Medical Writing, and Medical Communications Room 210C #234: Personalized Medicine Approaches During Early-Phase Clinical Research Room 156ABC #235: The Adventures of Patient Experience in Drug Development Room 252AB #238: The European Medical Devices Regulation and MDUFA IV: One Year On - Is It Any Clearer? Room 204AB #240: Biosimilars: Demonstrating Structural and Functional Similarity Room 253C #241: Time-to-Event Analysis in Clinical Trials Room 256

12:10pm EDT

#245: IQVIA Innovation Theater: Real World Evidence to Enhance Drug Development Theater 1 Exhibit Hall #246: AMPLEXOR Innovation Theater: How Regulatory Information Will Become Part of Your Company Big Data Architecture Theater 2 Exhibit Hall

1:10pm EDT

#247: BioClinica Innovation Theater: Transformational Trends in Investigator Site Payments 2018 Theater 1 Exhibit Hall #248: Veeva Systems Innovation Theater: Tufts Research - Strategies from Data Management Leaders to Speed Clinical Trials Theater 2 Exhibit Hall

1:30pm EDT

#250: Developing Standards to Support the Use of Wearables and Sensors for Objective Data Collection During Clinical Trials Content Hub NE Lobby

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 #267: Developing and Partnering on Evidence for Outcomes and Value Assessment: Standardizing Measurement for Patient-Centered Care Room 252AB #251: Risk Management: New Directions Room 253AB #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 #254: Risk-Based Monitoring for Master Protocol Study: A Dilemma and Possible Ways to Go Room 258C #256: CTD Regulatory Defense Strategies: How Best to Prepare Your Response to Health Authority Queries Room 210C #257: Globalizing and Regionalizing Medical Information Contact Centers Room 209 #259: Measuring the Impact of Patient Engagement: What to Ask Depends on Who You Ask Room 254AB #262: The Risk Assessment Is Done: Now What? A Guide to Setting Up a Centralized Monitoring Plan Room 205C #263: Navigating the Regulatory Landscape of Drug-Device Combination Products Room 204AB #264: Global Development Using Expedited Pathways in Established and Emerging Markets Room 206AB #265: ICH M9 BCS-Based Biowaivers Room 253C #266: User-Friendly Tools for Study Planning and Analysis Room 256

3:30pm EDT

#273: DIA Insights: Latest Global Healthcare Coverage and How to Get Published Content Hub NE Lobby

3:40pm EDT

#274: WIRB-Copernicus IRB Group Innovation Theater: Clinical Research Sites: Your Competitive Battleground for Study Success Theater 1 Exhibit Hall #275: Veeva Systems Innovation Theater: Simplifying Variation Management Theater 2 Exhibit Hall

4:15pm EDT

#284: Using Advocacy Partnerships to Improve Real World Evidence in Clinical Trials Room 151AB #293: Medical Monitoring in Non-Interventional Studies: Need for Medical Leadership and Study Primary Care Management Room 257AB #294: Sustainable Healthcare Funding Room 258AB #276: Patient Engagement in Pharmacovigilance Room 253AB #277: Pharmacovigilance: No Longer Going it Alone Room 253C #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 #287: The Letter and Spirit of Risk-Based Monitoring: How to Creatively Implement Risk-Based Modeling and Unlock the Potential of the Team Room 205C #289: Electronic Submissions Demystified Room 204AB #290: Priority Review Vouchers: Here to Stay and Worth the Effort? Room 206AB #292: Complex Innovative Designs and Model-Informed Drug Development Related: PDUFA VI Pilot Programs Room 256