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Monday, June 12
 

9:30am EDT

11A: Real-World Evidence: The Evolving Landscape of Regulators, Data, and Integrated Use Virtual

1:00pm EDT

12P: Understanding the Bayesian Approach in Decision Making for Anyone Involved in Clinical Trial Design or Interpretation Virtual
 
Tuesday, June 13
 

9:30am EDT

21A: Signal Management in Pharmacovigilance Virtual

1:00pm EDT

22P: Global Labeling: The Basics of Core Datasheet Virtual
 
Wednesday, June 14
 

9:30am EDT

31A: Introduction to Cell and Gene Therapies: Specific Regulatory, CMC, Non-clinical and Clinical Requirements and Considerations Virtual

1:00pm EDT

32P: Talking Statistics: Interpreting Statistical Results for Non-Statisticians Involved with Clinical Trials Virtual
 
Sunday, June 25
 

9:00am EDT

51F: Toolkit Approach to Best Practices in Root Cause Analysis and CAPA Management Workshop Room 157C 52F: Ecosystem of Digital and Data Innovation Partnerships: Generating Regulatory Grade Evidence in Diverse Patient Populations Room 252
 
Monday, June 26
 

8:00am EDT

#OR 1: Annual Meeting Orientation Room 253 A Coffee Service Ballroom Lobby 3

9:00am EDT

#100: Opening Plenary: Revolutionizing Life Sciences - How Diversity, Innovation, and Artificial Intelligence are Accelerating the Future of Health Grand Ballroom

10:45am EDT

#101: Artificial Intelligence: Delivering on the Promise Room 205 BC #103: Sponsor-CRO Collaborations and the Impact of Decentralized Clinical Trials Room 253 A #102: Risk-Based Monitoring in Clinical Trials: A Four-Year Analysis Room 254 #110: Disruptive Medicine Innovation: Combination Products Room 153 AB #114: Navigating the Constellation of Efforts to Increase Representation in Clinical Research Room 210 #104: Inspired by Big-Tech and Humbled by Complexity of Clinical Research: Clinical Trial Digital Transformation Room 206 #112: Applying Implementation Science Methods to Generate Evidence to Improve Access to New Therapeutics: What has Been Learned? Room 104 AB #111: E9(R1) Implementation: Practical Applications of Using Estimands in Protocols, SAPs, Data Standards and Examples of use of Estimands Room 102 #105: What’s in the Future for Global Advancements in Patient Engagement and Patient-Focused Medical Product Development? Room 205 A #106: New Alternative Methods-Only IND/CTA Application: Distant Dream or Immediate Possibility? Room 253 C #109: Cell and Gene Therapies Pulse Check Room 156 #107: Moving Into and Advancing In a Project Management Career Room 204 #108: Data Analytics for Quality Assurance: Shifting the Paradigm from Issue Detection to Quality Evidence Generation Room 253 B #113: Negotiating your Next Offer Room 252

11:45am EDT

Luncheon Service Exhibit Hall

12:00pm EDT

#115: Blockchain-Based Technologies for Clinical Research: Distinguishing Myth from Reality Content Hub NE Lobby #116: Roundtable Discussion: Navigating the Constellation of Efforts to Increase Representation in Clinical Research Grand Ballroom Zone 3A #117: Roundtable Discussion: Risk-Based Monitoring in Clinical Trials: A Four Year Analysis Grand Ballroom Zone 3B #POS 1: Professional and Student Poster Session 1 Exhibit Hall Entrance

12:05pm EDT

#118: IQVIA Innovation Theater: Addressing the Patient Recruitment Challenge - A Site Perspective Exhibit Hall Theater #1 #119: Advanced Clinical Innovation Theater: Where Are We, and Where Do We Need to Be? A Multistakeholder Look at the Clinical Research Talent Market Exhibit Hall Theater #2 #120: Yseop Innovation Theater: Reimagining the Future of Scientific Writing with Generative Artificial Intelligence Exhibit Hall Theater #3

12:45pm EDT

#121: How to Get Deep Insights on Treatment Decision Making Content Hub NE Lobby #122: Deloitte Innovation Theater: Evolving the Promise of AI in Pharmacovigilance to Reality Exhibit Hall Theater #1 #123: RWS Innovation Theater: The Power of e - How eConsent and eCOA can Improve Global Patient Experience and your Clinical Trial Exhibit Hall Theater #2 #124: Datacubed Health Innovation Theater: Better Experience for Better Data - Pulling ePRO into the Future Exhibit Hall Theater #3

1:30pm EDT

#125: Enhancing the Quality of Safety Data Collection Room 205 BC #126: Can We Further Innovate Clinical Trial Designs? Lessons Learned and Future Opportunities Room 206 #127: Patient-Reported Outcome Measures to Support Oncology Clinical Development and Labeling: Responding to FDA’s Draft Guidance Room 254 #138: Advances in Real-World Evidence: Real-World Data Hybrid Randomized Clinical Trials, Publication Scandal, and China’s Real-World Evidence Heaven Room 102 #129: Innovative Digital Health Technologies: Strategies for Successful Integrations, Quality, and Compliance Room 253 A #128: Building Trust: Data Privacy in Decentralized Clinical Trials Room 252 #130: On the Path to Enlightened Conversations: Setting up Structured Content Authoring Room 253 C #131: Beyond the Why: How to Effectively Implement a Patient-Led Approach to Clinical Trial Design and Conduct Room 205 A #132: Contemporary Challenges in Personalized Medicine and Companion Diagnostics Room 253 B #133: Unleashing the Fearless Quality Professional Room 204 #135: Combating Misinformation with Authoritative Medical Product Information Room 156 #134: Accelerated Approval in Rare Diseases: The Role of Novel Biomarker, Surrogate Endpoints, and Other Innovative Approaches in Expediting Development Room 153 AB #137: International Collaboration for Pharmaceutical Quality and Manufacturing Agility Room 151 #139: Do Surrogate Endpoints Expedite or Hinder Payer Coverage of Drugs? Room 104 AB

2:30pm EDT

Refreshment Break Exhibit Hall

2:45pm EDT

#140: Risk Management: Box Ticking or Value Add? Content Hub NE Lobby #141.1: Roundtable Discussion: Demystifying Statistical Concepts for ANYONE Involved with Clinical Trials Grand Ballroom Zone 2 #141: Roundtable Discussion: Beyond the Why: How to Effectively Implement a Patient-Led Approach to Clinical Trial Design and Conduct Grand Ballroom Zone 1

2:50pm EDT

#142: Parexel Innovation Theater: Early Planning for Clinical Trial Diversity - How Upfront Strategies Avoid Additional Time and Cost Exhibit Hall Theater #1 #143: PPD part of Thermo Fisher Scientific Innovation Theater: Exploring New Perspectives to Optimize Clinical Trial Design Exhibit Hall Theater #2 #144: H1 Innovation Theater: A Race to The Finish in Trial Success - Diversity, Feasibility, and Site Selection Exhibit Hall Theater #3

3:30pm EDT

#145: Speed Networking: Practice Makes Perfect Content Hub NE Lobby #146: eClinical Solutions Innovation Theater: Blueprint for the Modern Clinical Data Ecosystem with Embedded AI Exhibit Hall Theater #1 #147: SAS Institute Innovation Theater: Overcoming Clinical Operations Challenges from Protocol Design to Submission Exhibit Hall Theater #2 #148: Certara Innovation Theater: Evolution of Submissions and Technology from 1983-2063 Exhibit Hall Theater #3

4:15pm EDT

#149: Utilizing Wearable Biosensors to Better Manage Patient Safety During Immuno-Oncology Studies Room 205 BC #150: Enabling the Use of Randomized Pragmatic Studies to Generate High Quality Real-World Evidence for Regulatory Decisions Room 157 AB #151: What Patients and Care Partners are Saying about Hybrid and Decentralized Trials Room 254 #163: Creating your Career Plan 101: A Practical Workshop Room 252 #152: Digital Endpoints in Clinical Trials: Qualifications, Collaborations, and Risk-Based Approaches Room 206 #153: The True Decentralization of Clinical Trials: Benefits and Drawbacks of Blockchain Technology Room 253 A #162: Supporting Providers in Value-Based Contracts: Machine Learning and Recursive Neural Networks for Outcomes and Treatment Journey Optimization Room 204 #154: Best Practices in Effective Gathering of Medical Information Industry Insights Room 253 C #156: What's Next in Precision Medicine? Translational Strategies for Dose Optimization in the Age of Project Optimus Room 102 #157: IMPALA (IntercoMPany quALity Analytics) Industry Consortium: Quality Analytics Use Cases and Early Health Authority Feedback Room 253 B #158: Emerging Therapies and Technologies: Leveraging Opportunities for Engaging in Pre-Competitive Research and with Medicine Regulators to Support Innovation Room 153 AB #160: Regulatory Cooperation, Coordination, and Reliance in Times of Crisis: The ICMRA Role Room 104 AB #159: The Promise of Vaccine Platforms to Advance Regulatory Science: Where are we Now, Where are we Going, and How do we get There? Room 156 #161: Challenges in Analytical Development of Cell and Gene Therapy Products, Regulatory Perspectives, and Convergence Room 151 #163.1: Student Case Competition Content Hub NE Lobby

5:15pm EDT

DIA Welcome Reception supported by Optum Exhibit Hall

5:30pm EDT

#164: CRIO Innovation Theater: It’s all About the Sites! Sponsors - Reimagine your Approach to Clinical Trials Exhibit Hall Theater #1
 
Tuesday, June 27
 

8:00am EDT

Coffee Service North Lobby

8:30am EDT

#212: Full Exposure: Artificial Intelligence to Advance, Replace, and Add Efficiency for Patient Benefit Room 210 #201: Completing the Risk Management Cycle: Review of Risk Management Effectiveness Room 205 BC #203: Ethical Considerations for Conducting Research During Times of Disruption Room 254 #202: Innovating Patient Recruitment Through Pharmacy Channels Room 253 B #204: ICH M11 Clinical Electronic Structured Harmonized Protocol (CeSHarP): Enabling Consistency and Information Exchange Room 206 #205: The Case for Generating Synthetic Data as Real-World Data: Regulatory and Planning Perspectives  Room 253 A #206: Innovation Across Medical Affairs Throughout the Global Pandemic Room 253 C #207: Utilizing Analytics, Visualizations, and Decision Science to Drive Strategic Decision Making Room 204 #136: WHO Town Hall: The New Era of WHO Listed Authorities (WLAs), Reliance in Action, and Country and Regional Focus for Regulatory Systems Strengthening Room 205 A #208: NMPA Town Hall Room 151 #209: International Regulatory Convergence and Collaboration Room 153 AB #210: Pediatrics and the Paradox of Progress: What’s New, What’s Next, What’s Needed? Room 157 AB #211: Office of Generic Drugs/Office of Pharmaceutical Quality Town Hall Room 156

9:30am EDT

Coffee Break Exhibit Hall

9:45am EDT

#213: Flatiron Innovation Theater: Reinventing Prospective Study Data Acquisition and Delivery Exhibit Hall Theater #1 #214: Clario Innovation Theater: Go Slow to go Fast - Strategies and Techniques for Expanding Inclusion in Flexible Clinical Trials (DCT, Hybrid, etc.) Exhibit Hall Theater #2 #215: Zelta by Merative Innovation Theater: Decentralized Clinical Trials are Here to Stay – But how do we Work to Execute them Smoothly? Exhibit Hall Theater #3

10:30am EDT

#216: Benefit-Risk Balance for Medicinal Products: CIOMS Working Group XII Report Room 205 BC #217: Good Recruitment Practice Under Regulation (EU) No 536/2014 Room 254 #218: The Future of Regulatory Submissions: Opportunities and Challenges Room 206 #224: Time for Alignment? A Policy Landscape Update on the Use and Acceptance of Real-World Data/Real-World Evidence for Regulatory Purposes Room 153 AB #229: The Full Picture: Innovative Software Tools for Data Insight Generation and Exploration Room 102 #219: Medical Storytelling Inserted Into All Aspects of Medical Affairs Room 253 C #220: Disrupting the Status Quo: Best Practices for Bringing Together Patients and Medical Staff to Positively Impact Trial Diversity Room 205 A #221: The Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP) Collaboratory: Facilitation of Medical Product Development for Rare Diseases Room 252 #222: How to Make Good Decisions Quickly Room 204 #223: One Year On: How Quality Briefs are Transforming the Approach to Quality and Driving Innovation to Serve Patients Room 253 B #227: ANVISA Town Hall Room 253 A #225: Post-Pandemic Regulatory Innovation for Clinical Trials and Opportunities for Global Alignment Room 156 #226: Patient Experience Data in the Label: Closing the Loop Room 157 AB #228: A Regulatory Pharmaceutical Quality Knowledge Management System to Improve the Availability of Quality Medicines Room 151 #230: Is Mark Cuban Really Solving the Drug Pricing Problem? Room 104 AB

10:45am EDT

#OR2: Annual Meeting of the Members DIA Booth #539 EH

11:30am EDT

Community Networking Lunch Exhibit Hall South Luncheon Service Exhibit Hall

11:45am EDT

#231: Networking in Life Sciences is Essential Content Hub NE Lobby #233: Roundtable Discussion: Ethical Considerations for Conducting Research During Times of Disruption Grand Ballroom Zone 2 #232: Roundtable Discussion: What's Next in Precision Medicine? Translational Strategies to Dose Optimization in the Age of Project Optimus Grand Ballroom Zone 1 #234: Roundtable Discussion: How to Make Good Decisions Quickly Grand Ballroom Zone 3 #POS 2: Professional and Student Poster Session 2 Exhibit Hall Entrance

11:50am EDT

#235: Quest Innovation Theater: Storytelling with Lab Data Exhibit Hall Theater #1 #236: Deloitte Innovation Theater: Impact of Generative AI Across the Value Chain Exhibit Hall Theater #2 #237: Deep 6 AI Innovation Theater: Unlocking the Power of a Precision Research Ecosystem - Enhancing Decision-Making with Deep 6 AI's Clinical Trial Acceleration Software Exhibit Hall Theater #3

12:30pm EDT

#238: Simultaneous Writing of Clinical Reports, Summaries, and Overview for Submissions: Is this the New Normal? Content Hub NE Lobby #239: IQVIA Innovation Theater: Improving Outcomes with Connected Intelligence from Enrollment Planning to Trial Conduct Exhibit Hall Theater #1 #240: endpoint Clinical Innovation Theater: Transforming Data Concepts into Authentic Assets in your eClinical Network Exhibit Hall Theater #2 #241: Medable Innovation Theater: Driving the New Era of Clinical Development Exhibit Hall Theater #3

1:15pm EDT

#242: Novel Methods for Signal Identification for Medicines and Medical Devices Room 205 BC #244: Meta-Collaboration to Improve Decentralized Trial Excellence: Updates from the Collaboration Landscape Room 254 #243: Hot off the Press: Site Challenges and Solutions in Workforce and Technology Room 253 A #245: Global Regulatory Perspectives About Real-World Data: DARWIN EU®, FDA, and Other Current Initiatives Room 206 #253: Quality in the Real World: Identifying and Addressing Inaccuracies and Gaps in Routinely Collected Patient Data Room 102 #246: Tech-Enabled Narratives: Technology Meets Process FTW (For the Win!) Room 253 C #247: Measuring Impact of Patient Engagement Across Research and Development Room 205 A #248: Agile Project Management Practitioners Tackle Challenges Within the Life Sciences Room 204 #255: Future- Proofing your Career: The Essential Guide for all Things Legal and Venture Capital for Biopharma Professionals Room 252 #249: Pharmacovigilance: Regulator's Perspectives on Quality Approaches to Additional Risk-Minimization Measures and Post-Pandemic Inspection Reflections Room 253 B #251: Asia Town Hall Room 153 AB #250: Implementing Digital Health Technologies in Clinical Trials: How to Apply New Resources to Address Key Questions Room 156 #252: One Dossier and One Timeline for a Post Approval Change: The Story of a Regulatory Reliance Pilot! Room 151 #254: The Inflation Reduction Act Price Setting: What are the Impacts on Biopharmaceutical Innovation from Different Perspectives? Room 104 AB

2:15pm EDT

Refreshment Break Exhibit Hall

2:30pm EDT

#256: Patients’ Engagement in Drug Development and in Public Private Partnerships Content Hub NE Lobby #258: Roundtable Discussion: Benefit-Risk Balance for Medicinal Products: CIOMS Working Group XII Report Grand Ballroom Zone 2 #257: Roundtable Discussion: Disrupting the Status Quo: Best Practices for Bringing Together Patients and Medical Staff to Positively Impact Trial Diversity Grand Ballroom Zone 1 #259: Roundtable Discussion: A Regulatory Pharmaceutical Quality Knowledge Management System to Improve the Availability of Quality Medicine Grand Ballroom Zone 3

2:35pm EDT

#260: Parexel Innovation Theater: Scaling Large Language Models in Clinical Research for Unprecedented Efficiencies Exhibit Hall Theater #1 #261: Fortrea Innovation Theater: Key Components to Achieving Patient-Centric Trial Design - How the Pandemic Unlocked the Potential for Flexibility in Trial Execution Exhibit Hall Theater #2 #262: Calyx Innovation Theater: Experience of Using Artificial Intelligence Technology to Identify Biomarkers in Clinical Trials Exhibit Hall Theater #3

3:00pm EDT

#262.1: DIA Publications Workshop: Bring Your Ideas and Find Your Path to Publication Room 252

3:15pm EDT

#263: RIM Reference Model: An Approach to RIM Data Harmonization and Improving Efficiency, Compliance, and Interoperability Content Hub NE Lobby #265: UBC Innovation Theater: RWE Case Study - Patient-Centric, Hybrid, Post-Marketing Research Exhibit Hall Theater #2 #266: Celonis Innovation Theater: EMS Provides Process Intelligence to Drive Operational Efficiency and Improve Cycle Times in Life Sciences Exhibit Hall Theater #3

4:00pm EDT

#268: Smarter Approaches to Pharmacovigilance Challenges Room 205 BC #267: Negotiating your Way Through the Vigilance Agreement Maze: Is There a Better Way? Room 204 #269: The Many Faces of In-Trial Interviews: Navigating Operational and Scientific Waters to Optimize Value for Clinical Trials Room 254 #278: Patient-Preferences and Multistate Models to Enhance Patient-Focus of Traditional Endpoints in Oncology Room 102 #270: SMART-on-FHIR: Integrating Electronic Health Records as Real-World Data Room 206 #271: IDMP Standards, Structured Submissions, and Data Harmonization Methods: How Will Your Company be Impacted? Room 253 A #272: On the Path to Enlightened Conversations: Implementing Structured Content Authoring (Part 2) Room 253 C #276: Globally Accelerating the Drive to eLabeling for All Room 156 #273: An Assessment of the Challenges Associated with Cell and Gene Therapies: Are Digital Health Technologies the Way Forward? Room 205 A #274: Modernizing Clinical Trials: A Regulatory Perspective Room 253 B #277: Quality and CMC Aspects of Recent US Legislation: Challenges and Opportunities Room 151 #275: PMDA Town Hall Room 153 AB #279: Improving Patient Access with Real-World Evidence: A Framework for Coverage and Formulary Decisions Room 104 AB
 
Wednesday, June 28
 

8:00am EDT

Coffee Service North Lobby

8:30am EDT

#301: Using Real-World Data to Evaluate Safety Signals Room 205 A #302: Pharmacovigilance in Africa: Nigeria and Ghana Health Authorities Share their Perspectives Room 205 BC #308: Strategies for Benefit-Risk Analysis in Regulatory Submissions Room 204 #303: Returning Individual Participant Data: A Cultural and Operational Shift Towards Personalized Clinical Trial Options Room 254 #305: Real-World Data Quality: Components and Considerations of Data Sources Used for Regulatory Decision-Making Room 253 A #304: The Rapidly Changing Landscape of Data Collection and its Implications for Clinical Data Management Room 206 #306: Writing Summary Documents for Rare Disease Submissions: Unique Challenges Room 253 C #310: A Case Study for Illumined Therapeutic Development: Shining the Light on ALS Room 210 #307: Leveraging Project Management Skills for Significant Drug Development Deliverables Room 253 B #309: Strategies to Make the Right Connections and Developing Relationships in a Virtual Network Room 252

9:30am EDT

Coffee Break Exhibit Hall

9:45am EDT

#311: Evernorth Innovation Theater: Inclusive Clinical Trial Site Planning Using Social Determinants of Health (SDoH) Exhibit Hall Theater #1 #312: Lokavant Innovation Theater: Accelerated and Predictive Study Planning with Real-World Data-Driven Artificial Intelligence Exhibit Hall Theater #2 #313: Castor Innovation Theater: A Paradigm Shift: - Unleashing the Power of DCT and LLM Exhibit Hall Theater #3

10:30am EDT

#315: Opportunities to Improve Risk Minimization Outcomes with Behavioral Science Room 253 C #314: Registries Aren’t Always the Answer: Novel Designs for Executing Post-Market Pregnancy Requirements Room 205 BC #316: Best Practices for Managing Rare Disease Trials in Latin America as an Emerging Region Room 254 #318: Operationalizing Real-World Data: Methods, Acceptance, and Future Hopes  Room 253 A #317: Leveraging Data Scientists and Data Managers in Clinical Data Management Room 206 #328: How Real-World Data from Wearable Biosensors and Artificial Intelligence (A)I-Based Analytics Is Enabling the Shift from Efficacy to Effectiveness Room 104 AB #319: Is the Hype Real? Real-Life User Experience of Medical Writing Artificial Intelligence Tools for Clinical Study Reports Production Room 252 #320: Combining Qualitative and Quantitative Research to Generate Within-Patient Meaningful Changes in Clinical Outcome Assessments Room 205 A #321: What Can ICH Bring to the Future of Model-Informed Drug Development (MIDD)? Room 204 #322: PI 1572 Responsibility and Oversight in Decentralized Clinical Trials Room 253 B #323: 25-Years After FDAMA: How is FDA Applying the Confirmatory Evidence Standard for Substantial Evidence of Effectiveness? Room 153 AB #325: Health Canada Town Hall Room 157 AB #326: Reliance in Action: How to Ensure Product Sameness When Using Global Supply Chains Room 151 #324: Dose Optimization in Oncology: How Do we Tackle the Tricky Topic of Combinations? Room 156 #327: Patient-Focused Drug Development in Rare Disease Endpoint Selections Room 102

11:30am EDT

Luncheon Service Exhibit Hall

11:45am EDT

#329: Optimal Uses for Long-Term Patient Councils Content Hub NE Lobby #330: Roundtable Discussion: IDMP Standards, Structured Submissions, and Data Harmonization Methods: How Will Your Company will be Impacted? Grand Ballroom Zone 1 #331: Roundtable Discussion: Writing Summary Documents for Rare Disease Submissions: Unique Challenges Grand Ballroom Zone 2 #332: Roundtable Discussion: Strategies for Benefit-Risk Analysis in Regulatory Submissions Grand Ballroom Zone 3

11:50am EDT

#333: IQVIA Innovation Theater: Long Term Follow up for Cell and Gene Therapies – Real-World Approaches to Drive Success Exhibit Hall Theater #1

1:15pm EDT

#339: Operationalizing FDA Medical Queries Room 205 BC #350: Opportunities and Issues with Existing Analytical Technologies for Safety Monitoring of Ongoing Clinical Studies Room 102 #351: Real-World Data: Maximizing Value and Quality Through End-to-End Patient Centricity Room 104 AB #340: Regulatory Insights into Decentralized Clinical Trials Room 254 #348: The Future of Biosimilar and Interchangeable Biologics: Global Development, Harmonization, and the Inflation Reduction Act Room 156 #341: Managing BYOD and Wearables in Clinical Trials: Sustainable Data Collection Room 206 #342: Real-World Data Standards and Protocol Designs for Information Exchange and Data Flow  Room 253 A #343: Introduction to Estimands and Incorporation of the Estimand Framework in Protocols Room 205 A #344: Capturing the Patient Voice Using Longitudinal Qualitative Research Methods in Medical Product Development Room 204 #345: Fostering Cross-Functional Team Success by Leveraging Project Management and Alliance Management Best Practices Room 253 C #352: Performance, Interrupted: Examining Diversity, Equity, and Inclusion Dynamics that can Impact Team Performance in Drug Development Room 252 #346: Industry and Regulators’ Experience with the Implementation and Use of Remote and Electronic Consent Room 253 B #347: FDA Rare Disease Town Hall Room 153 AB #349: Evolving Global Landscape for Addressing Drug Shortages: Innovative Technology and Regulatory Strategies Room 151

2:15pm EDT

Refreshment Break Exhibit Hall

2:30pm EDT

#353: Roundtable Discussion: Operationalizing FDA Medical Queries Grand Ballroom Zone 1 #355: Roundtable Discussion: Crafting the Message: Driving Drug Development Through Compelling Governance Interactions Grand Ballroom Zone 3 #354: Roundtable Discussion: Real-World Data: Maximizing Value and Quality through End-to-End Patient Centricity Grand Ballroom Zone 2

4:00pm EDT

#362: Assessing Safety in Rare Disease and Gene Therapy Room 205 BC #372: Patient and Quality Impacts of Restrictions on the Use of Titanium Dioxide (TiO2) in Medicines Room 151 #373: From 1000's of Tables to Summarizing and Interactively Exploring Clinical Trials Data Room 102 #364: Can Pragmatic Trials Simultaneously Meet the Needs of Regulators, Payers, and Clinical Care? Room 254 #374: Critically Thinking Organization: An Action-Oriented Workshop for Leaders Room 252 #363: Modernizing the Clinical Trials Environment in Europe: ACT EU and the New EU Clinical Trial Regulation Room 253 A #365: Ethics-by-Design: Embedding Ethics into Uses of Data and Artificial Intelligence in the Pharmaceutical Industry Room 206 #366: Patient-Generated Health Data and Real-World Evidence: How Can They Be Used to Accelerate Patient Engagement and Diversity? Room 205 A #367: Leading Cross-Functional Teams Through Mergers, Divestments, and Acquisitions Room 253 C #368: Quality by Design for Real-World Evidence Studies Room 253 B #369: Mobilizing Cooperation with the African Medicines Agency Room 153 AB #370: Regulatory Reliance: Addressing Gaps to Harmonize and Enhance Uptake Globally Room 156 #371: ICH Work to Harmonize Requirements for Safe and Effective Medicines: What’s in It for Patients? Room 157 AB
 
Thursday, June 29
 

8:00am EDT

Coffee Service North Lobby

8:30am EDT

#401: Implementing the Program Safety Analysis Plan and Enhancing Ongoing Aggregate Review with an Interactive Open-Sourced Tool Room 205 BC #402: Reverse-Engineering Digital Endpoints to Improve Trial Design and Expand Diversity and Access Room 254 #411: Demystifying Statistical Concepts for ANYONE Involved with Clinical Trials Room 204 #403: Effective Use of Intelligent Automation in Clinical and Regulatory Room 206 #404: Implementation of the New EU Clinical Trials Regulation Room 253 C #405: CIOMS: What it Does and the Guideline on Patient Involvement in the Development, Regulation, and Safe Use of Medicines Room 205 A #406: The Value of Patient-Centric Communication Strategies Room 253 A #407: Crafting the Message: Driving Drug Development Through Compelling Governance Interactions Room 252 #408: FDA Sponsor Interaction: Best Practices and New PDUFA Formal Meetings Room 153 AB #409: ACCESS Consortium: What's Next? Room 156 #410: International Medical Device Regulators Forum (IMDRF) and Technological Innovation: How International Medical Device Harmonization is Impacting Drug Strategy Room 157 AB

9:45am EDT

#412: Reporting of Pre- and Postmarket Safety Reports to FDA Adverse Event Reporting System (FAERS) Using ICH E2B Standards Room 204 #413: The Other Side of the Table: Drug Development Professionals Share Their Experiences Participating as Patients in Trials Room 205 BC #414: Process Automation and Artificial Intelligence in the Field: Practical Applications Room 206 #415: Statistical Applications of Machine Learning (ML) and Artificial Intelligence (AI) in Drug Development and Success Stories of Application Room 205 A #416: EMA-FDA Question Time Room 210

10:45am EDT

Coffee Break Outside Room 210

11:15am EDT

#417: FDA Town Hall Room 210
 
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Virtual
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient Engagement
  • 06: TranslationalScience-PrecisionMedicine
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics
  • 12: Value-Access
  • 13: ProfDevelopment
  • 14: DIAmond
  • 15: Content Hubs
  • 16: Community Rounds
  • 17: Networking Opportunities
  • 18: Posters
  • 19: InnovationTheaters
  • 20: Short Courses
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Featured Topics
  • Artificial Intelligence (AI)
  • Benefit - Risk
  • Cell and Gene Therapy
  • Decentralized Clinical Trials (DCTs)
  • Digital Technology
  • Diversity Equity and Inclusion (DEI)
  • Dose Optimization
  • Endpoints
  • Ethics
  • Patient Focused
  • Rare Disease
  • Real-World Data (RWD) - Real-World Evidence (RWE)
  • Regulator Thinking
  • Regulatory Collaboration
  • Student Programming