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10:00am • #100 SL: DIA Global Annual Meeting - Opening DIAmond and Plenary Session
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12:00pm • #104 IT: Syneos Health Innovation Theater: Accelerating Clinical Trial Recruitment - A New Path To Speed Enrollment
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12:00pm • #101 CH L: Results from a Survey of Biopharmaceutical on Attitudes Towards the Use of Wearables and Sensors in Clinical Research
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12:00pm • #105 IT: IQVIA Innovation Theater: Redefining Patient Engagement and Recruitment Beyond 2021
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12:00pm • #102 CH L: How to Share Individual Patient-Level Data Safely for Pharma Innovation
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12:00pm • #105.1 NTW: Meet the DIA Fellows
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12:00pm • #103 IT: Advanced Clinical Innovation Theater: Decentralized Clinical Trials: The Wave of the Future
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12:30pm • #108 IT: Deloitte (ConvergeHEALTH) Innovation Theater: Automating Adverse Event Case Processing Through Machine Learning and Innovation
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12:30pm • #110 SC L: Solution Circle: Where Do We Go From Here? DCTs and Patient Centricity Post-COVID-19
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12:30pm • #109 SC L: Solution Circle: QPPV Perspective on Brexit - Is Your Pharmacovigilance System Compliant?
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12:30pm • #107 IT: UBC Innovation Theater: Critical Components for Successful Vendor Selection: CRO, PV, Registries and REMS Services
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12:30pm • #106 IT: Anju Software Innovation Theater: Utilizing Adaptive Technology Systems to Get the Most from Decentralized Trials
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1:00pm • #114 SL: Machine Learning Enabled Digital Data Flow and Advanced Real-World Evidence
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1:00pm • #115 SL: Patient-Centric Engagement Strategies
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1:00pm • #120 SL: Defining Quality for Cell and Gene Therapy Products
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1:00pm • #113 SL: Technology Changes Needed to Manage Drug Supply for Decentralized Trials
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1:00pm • #123 SL: Skills of the Future/The Future of Work
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1:00pm • #117 SL: Leveraging Pharma Intelligence Data and Statistical Modeling to Inform Project Strategies
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1:00pm • #116 SL: Implicit Bias in Early Phase Clinical Trials: The Sociocultural Implications of Advancing the Science
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1:00pm • #112 SL: Measuring Clinically Meaningful Change of Function: A Case Study of Patient-Centered Clinical Outcome Assessments in Early Parkinson’s Disease
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1:00pm • #121 SL: Statistical Considerations with the Patient in Mind
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1:00pm • #119 SL: FDA Perspectives on Modernization of Clinical Trials: Clinical Practice Data, Decentralized Trials, Digital Health Technologies
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1:00pm • #122 SL: Market Access, Medical Affairs, and Regulatory Affairs Functions Working Together to Address Payor and Regulatory Requirements
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1:00pm • #111 SL: COVID-19 Real-World Data Analysis and Vaccine Surveillance: Examples from FDA and The Danish Medicines Agency’s Approaches
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1:00pm • #118 SL: Advanced Analytics, Cross-Industry Collaboration, and Data Sharing to Change the Paradigm in Clinical Quality
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2:00pm • #126 IT: IBM Innovation Theater: Embracing Hybrid - How New Technologies, Synergized with Proven Solutions, Will Shape the Journey to Commonplace Decentralized Trials
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2:00pm • #125 IT: PPD Innovation Theater: Continuous Development and Flexible Architecture of the PPD® Laboratories’ Central Lab Preclarus® Portal to Meet the Changing Needs of Clinical Trials
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2:00pm • #124 IT: ArisGlobal Innovation Theater: Minimizing Noise to Improve Your PV Case Processing
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2:30pm • #130 SL: Real-World Response: Harnessing Electronic Health Records to Develop Robust Clinical Endpoints in Solid Tumors
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2:30pm • #133 SL: Role of Clinical Pharmacology Guidances and Policies in Enhancing Drug Development
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2:30pm • #134 L: Risky Business: How to Successfully Manage Project Risk
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2:30pm • #137 SL: Health Canada Town Hall
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2:30pm • #132 SL: Ensuring Patient Engagement Methodologies Are ‘Fit for Purpose’ from the Beginning: A Key Factor for Meaningful Outcomes
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2:30pm • #139 SL: Hiding in Plain Sight: Quantifying Underdiagnosed Populations
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2:30pm • #136 SL: Parallel Scientific Advice: Increasing International Dialogue Early in the Product Lifecycle
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2:30pm • #135 SL: Risk-Based Remote Site Monitoring
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2:30pm • #138 SL: Advancing ICH Quality Standards to Support Continual Improvement and Innovation in Manufacturing Technologies and Approaches
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2:30pm • #128 SL: FDA Science Strategies: Purposeful Scientific Leadership to Advance Innovation and Improve Patient Outcomes
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2:30pm • #131 SL: How are Medical and Health Economics Data Generated and Disseminated to Various Customer Segments?
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2:30pm • #127 SL: Are You Ready for a NISS? Industry and Regulatory Perspectives on the US FDA Newly Identified Safety Signal Process
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2:30pm • #129 SL: Walking the Talk: What Happens When Clinical Trialists Join Clinical Trials?
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3:30pm • #142 IT: Microsoft Innovation Theater: Massive Deep Learning Language Models and the Application to Life Sciences
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3:30pm • #141 IT: Medidata Innovation Theater: Bench to Market in Record Time with Decentralized Technology
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3:30pm • #140 IT: Phlexglobal Innovation Theater: Streamlining TMF Documentation Through Clinical Automation
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4:00pm • #153 SL: Regulatory, Industry, Patient, and Academic Perspectives on Machine Learning in Clinical Trials
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4:00pm • #146 SL: Driving Innovation in Data Standards and Regulatory Submissions at FDA
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4:00pm • #143 SL: A Journey of Interdisciplinary Collaboration to Improve Safety Evaluation in Drug Development
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4:00pm • #149 SL: Culture of Quality: A Competitive Advantage
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4:00pm • #145 SL: Realizing the Value of Digital Biomarkers Across the Product Lifecycle
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4:00pm • #154 SL: How Can We Compliantly Exchange Pre-Approval Information with Payers
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4:00pm • #148 SL: Challenges and Opportunities in Early Development of RNA Therapeutics
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4:00pm • #151 SL: Next Generation of Combination Products: Insights from the FDA Office of Combination Products and Industry Expert Application
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4:00pm • #147 SL: Advancing the Science of Patient Input: How are WE doing? Multi-Stakeholder Perspective
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4:00pm • #152 SL: Implementation Progress of ICH Q12
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4:00pm • #155 SL: Yes it's about Science, Yes it's about Patients but it's Also ALL About Business
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4:00pm • #144 SL: Launching Megatrials During a Pandemic: Lessons Learned from COVID-19 Vaccine Clinical Trials
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4:00pm • #150 SL: Continuity of Randomized Controlled Trials During the Trying Times of COVID-19 and What We’ve Learned
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8:00am • #202 IT: Unqork Innovation Theater: Unqork for Clinical Trials
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8:00am • #201 IT: WCG Innovation Theater: Tailored Preparation for Site Success and Trial Continuity - WCG Site Augmentation
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9:00am • #203 SS: Spotlight Symposia: Important Gaps to Fill with Diversity and Inclusion in Clinical Trials - Moving Beyond Recognition to Action
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9:00am • #204 SS: Spotlight Symposia: Tales from the Front: Patient Equity and Engagement in Practice from Trial Design Through Execution
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9:00am • #205 SS: Spotlight Symposia: Three Paths to Success in a Post-COVID World
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9:30am • #208 IT: Oracle Innovation Theater: Untangling the Integration Mess of Today’s Digital eClinical
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9:30am • #209 IT: Medidata Innovation Theater: Engaging Patients Pre- and Post-trial with Registries
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9:30am • #206 CH L: Acceleration of Clinical Research by Simultaneously Leveraging Real-World and Clinical Trials Data
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9:30am • #207 IT: IQVIA Innovation Theater: Driving the Digitization of Clinical Development – Understanding the Impact of Innovative Digital Approaches
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10:00am • #219 SL: Advancing Medicines’ Regulation in Europe: Key Strategies to 2025
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10:00am • #216 SL: Brave New World: Early Clinical Trials in a Pandemic
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10:00am • #211 SL: Managing Global Trials in Latin America: Covid Impact Update
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10:00am • #213 SL: Perspectives on Real-World Data/Evidence Collection Through Expanded Access During the Covid-19 Pandemic
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10:00am • #218 SL: Novel and Innovative Approaches to Inspections: Verification of Quality and Compliance Using Remote Methodologies and New Technology
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10:00am • #214 SL: Developing a Best-in-Class Learning and Performance Program for the MSLs of Today and the Future
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10:00am • #221 SL: Global Harmonization of Complex and Innovative Trial Designs
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10:00am • #217 SL: Project Management in Times of Crisis: Perspectives from PMs Supporting COVID-19 Related Projects
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10:00am • #212 SL: Post COVID: Sites Evolving Role in the Clinical Trial Ecosystem
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10:00am • #220 L: Office of Generic Drugs and Office of Pharmaceutical Quality Generics Town Hall
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10:00am • #215 SL: Pediatric Engagement in Research: Young People Have a Voice
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10:00am • #210 SL: Assuring Access to Safe Medicines in Pregnancy and Lactation: International Regulators Perspective
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11:00am • #224 IT: Syneos Health Innovation Theater: Partnering to Innovate - The Way Forward for Decentralized Clinical Trials
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11:00am • #253 IT: Generis Innovation Theater: Optimizing Regulatory Affairs with Structured Content Authoring
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11:00am • #222 CH L: Patient-Reported Outcomes: Going Beyond Clinical Trials
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11:00am • #223 IT: PPD Innovation Theater: Capacity Management Through Upheaval
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11:30am • #225 SL: International Coalition of Medicines Regulatory Authorities (ICMRA): Harnessing Achievements During COVID-19 for the Future
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12:00pm • #225.1 NTW: How to Ensure Quality in Cell and Gene Therapies
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12:30pm • #227 IT: Quest Diagnostics Innovation Theater: Healthcare Analytics Solutions, LeveragingPatient-Centric Data to Empower Pharmaceutical Organizations and CROs
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12:30pm • #226 IT: Statistics & Data Corporation (SDC) Innovation Theater: Artificial Intelligence and Machine Learning - Infrastructure and Team Architecture Enabling Efficient Capabilities
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12:30pm • #228 IT: Certara Synchrogenix Innovation Theater: Medical Writing and Submission Compilation Made Easy - Technology Solutions from Regulatory Experts
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1:00pm • #229 RT L: Round Table Discussion: Implicit Bias in Early Phase Clinical Trials: The Sociocultural Implications of Advancing the Science
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1:15pm • #231 IT: Parexel International Innovation Theater: A Collaborative Trial Delivery Platform to Expedite Research
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1:15pm • #230 IT: ERT Innovation Theater: Check Your Blind Spots: A Holistic Approach to Patient-Centric Decentralized Clinical Trials
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1:30pm • #235 SC L: Solution Circle: Conducting Clinical Trials in China
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1:30pm • #233 CH L: The Clinical Impact of Medical Information for Healthcare Professionals
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2:00pm • #239 L: Quality by Design for Clinical Trials: A Hands-On, Multi-Stakeholder Workshop
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2:00pm • #236 L: Systems Thinking: A Better Way of Safety Management Planning
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2:00pm • #245 SL: GCP Quality and Compliance: The Regulator’s Perspective
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2:00pm • #238 SL: Are External Control Arms Ready for Primetime?
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2:00pm • #240 SL: Driving Change Globally: Transforming the Regulators as Early Digital Adopters
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2:00pm • #242 L: Navigating Non-Trial Preapproval Access as a Patient
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2:00pm • #243 SL: Epigenetic Drugs: Taking it to the Clinic- An Up-and-Coming Mode of Targeting Disease
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2:00pm • #241 SL: Opportunities for Harmonization of Clinical Trial Information in Regulatory Documents
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2:00pm • #246 SL: Global Regulatory Harmonization for Increased Patient Access to Medicines Through the International Council for Harmonisation (ICH)
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2:00pm • #250 SL: How Can Real-World Evidence be Communicated Compliantly to Payers or Healthcare Providers?
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2:00pm • #237 SL: Diversity in Clinical Research: Practical Strategies for Taking Personal Action
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2:00pm • #249 SL: Innovative Statistical Strategies and Designs in Oncology Drug Development
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2:00pm • #244 SL: How to Stay Grounded in Project Management Best Practices While Moving at the Speed of Light Integrating a New Company
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2:00pm • #248 L: Supporting Quality/CMC Development in Early Access Approaches (PRIME/Breakthrough Designation)
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2:00pm • #247 SL: Update on FDA's Real-World Evidence Program: Current FDA Demonstration Projects
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3:00pm • #251.1 NTW: Patient Scholar Meet Up
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3:00pm • #251 RT L: Round Table Discussion: Advancing Medicines’ Regulation in Europe: Key Strategies to 2025
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3:00pm • #252 SS: Spotlight Symposia: Managing Stakeholders in the Decentralized and Hybrid Clinical TrialEcosystem
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3:00pm • #250.1 RT L: Round Table Discussion: FDA Perspectives on Modernization of Clinical Trials: Clinical Practice Data, Decentralized Trials, Digital Health Technologies
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3:00pm • #252.1 SS: Spotlight Symposia: Requirements of Site Training Technology in the New Research Landscape
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3:15pm • #232 IT: DocuSign Innovation Theater: Maintain Compliance While Serving a New Generation of Digital-First Customers
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3:15pm • #254.1 IT: Labcorp Drug Development Innovation Theater: ICYMI - Game on! How Gamification Drives Engagement in Pediatric and Adolescent Clinical Trials
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3:15pm • #254 IT: Deloitte (ConvergeHEALTH) Innovation Theater: Using AI to Drive Clinical Data Automation
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4:00pm • #265 SL: A Regulatory/Industry Panel on Estimands: Alignment of the Clinical Objective, Trial Design, Analysis, and Interpretation
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4:00pm • #261 SL: Innovative Approaches to Trial Execution, Quality, and Compliance
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4:00pm • #256 SL: Innovative and Efficient Trial Designs and Statistical Approaches in Small Patient Populations: Rare Diseases and Pediatrics
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4:00pm • #263 SL: Pandemic Preparedness: Accelerating Treatments to Overcome Antimicrobial Resistance
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4:00pm • #258 SL: Effective Medical and Scientific Stakeholder Engagement: Are Digital Solutions The Answer?
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4:00pm • #255 SL: Treating Covid-19 Patients with Unproven Interventions Outside Trials: EUAs, Expanded Access, Right to Try, and Off-Label Use
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4:00pm • #260 SL: What Do We Do Now? Why You Need A Resource for Ethical Questions During Drug Development
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4:00pm • #259 SL: Parents Just Don’t Understand: Does This Apply to Healthcare Too?
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4:00pm • #264 SL: Multinational Collaborative CMC Review for Efficient and Rapid Product Approval
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4:00pm • #262 SL: Frameworks for Digital Endpoints via the IND Pathway
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4:00pm • #257 SL: Is There a Role for Federal Incentives to Stimulate Greater Diversity in Clinical Trials?
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9:00am • #403 SS: Spotlight Symposia: The Do’s and Don’ts of Compensating Research Participants: Guidance for Clinical Research Stakeholders
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9:00am • #402 SS: Spotlight Symposia: Decentralized Clinical Trials - Accelerate Drug Development Through Anytime, Anywhere Participation
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9:00am • #401 SS: Spotlight Symposia: Pragmatic Innovation in Clinical Trials: Broader Access, Better Evidence, and Faster Approvals
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9:30am • #404 CH L: Speed to Submission: How Fast Can You Truly Go?
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9:30am • #405 IT: Labcorp Drug Development Innovation Theater: Diversifying Clinical Trial Populations from the Ground Up
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10:00am • #406 SL: Development of Shared System and Shared REMS: Best Practices and Lessons Learned
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10:00am • #407 SL: Reliability of Data Results in Clinical Trials (ICH E6 (R2)): What Does it Mean and How Can it be Accomplished?
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10:00am • #412 SL: Integrated Assessment of US Marketing Applications: A View into FDA Internal Operations
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10:00am • #409 SL: Recent Developments and Strategies in Pediatric Drug Development Documentation
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10:00am • #415 SL: Fairness and Bias Detection and Mitigation in Machine Learning Algorithms: Real-World Evidence Applications and Examples
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10:00am • #410 SL: Patient-Focused Drug Development in Rare Diseases: Applying Guidances and Case Studies from the Field
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10:00am • #416 L: Remaining Challenges to the COVID-19 Response
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10:00am • #411 SL: Virtual Project Management: A Way Forward!
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10:00am • #413 SL: Using Cloud-Based Platforms to Transform Global Regulatory Data Exchange
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10:00am • #408 SL: The Data Scientist’s Handbook: ‘Good Science’ Principles in Non-Interventional Studies
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10:00am • #414 SL: How to Avoid Shortages? Insights from the EU Executive Steering Group on Shortages – Learnings from the COVID-19 Pandemic
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11:00am • #418 IT: ERT Innovation Theater: VIRTUAL VISITS: Innovations to Support Hybrid & Decentralized
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11:00am • #419 IT: WCG Innovation Theater: Managing Adjudication in an Increasingly Remote World
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11:30am • #423 SL: The Pain and the Pleasure: Lessons from Going Live with a Structured Content Management (SCM) System
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11:30am • #426 SL: Emergency Use Pathways: What Leanings from COVID-19 Can be Generalized to Address Unmet Medical Needs?
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11:30am • #430 SL: Needs Assessment: Key Factor in Value-Based Funding for Medical Device Innovation
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11:30am • #421 SL: Remote Implementation of Clinical Outcome Assessments During the COVID-19 Pandemic and Beyond
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11:30am • #427 SL: Real-World Evidence: A Global Regulatory Perspective and Discussion
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11:30am • #420 SL: The Spirit of the IND Safety Reporting Final Rule
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11:30am • #424 SL: Meaningful Patient Engagement Highlighted Through Patient Preference Studies and Core Outcome Sets
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11:30am • #428 SL: Mobilizing Manufacturing: Portable and Point of Care Manufacture of Medicines
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11:30am • #422 SL: EHR Interoperability Supporting COVID-19 Critical Care and Research
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11:30am • #425 SL: Regulator Perspective: Maintaining GCP During Covid-19 and Beyond the Pandemic
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11:30am • #431 L: Managing the Remote World: Concrete Strategies for Productivity and Balance
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11:30am • #429 SL: The Journey to a Modernization of Analytics
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12:30pm • #432.1 NTW: Advancing Diversity, Equity, and Inclusion in Drug Development
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12:30pm • #432.2 NTW: Make Connections and Advance Science in DIA Communities
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12:30pm • #432 RT L: Round Table Discussion: Round Table Discussion: Virtual Project Management - New PMBOK Framework - Overview and Implications for Pharma!
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1:30pm • #433 CH L: Value-Based Contracting in Action
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1:30pm • #434 SC L: Solution Circle: The Burden of Safety Reporting on Sites - What Sponsors of Choice do Differently
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2:00pm • #444 L: Mindfulness: The Power to Be Here, Now
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2:00pm • #439 SL: Preparing Medical Information for Emergency Use Authorization (EUA) to a Full Launch During the COVID-19 Pandemic
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2:00pm • #436 SL: What is the Breakthrough Risk Communications and Assessing Safety After Early Access to Pharmaceuticals?
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2:00pm • #445 SL: Career Compass: How do you Find and Define your Career Motivators (s) (True North) in a Transforming / Ever-Changing Workforce
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2:00pm • #438 SL: The Relationship Between Data, AI, and Bias
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2:00pm • #440 SL: Predictive Compliance, Risk, and Quality Management Transformation: Will your Data Hold up to a Data Integrity Inspection?
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2:00pm • #441 SL: Managing in Complexity: Emergency Use Authorizations Process and COVID-19 Lessons Learned
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2:00pm • #446 L: EMA-FDA Question Time
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2:00pm • #442 SL: Population Diversity Considerations in Clinical Trials
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3:30pm • #447 SL: FDA Town Hall
