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Tuesday, June 21
 

8:00am CDT

Coffee Service Meeting Rm Lobby Level 1

9:00am CDT

#202: Innovations in Risk Minimization: Methods, Tools, and Design Approaches Room 176 #201: Transforming PV at the MHRA Room 175 #203: The Site Landscape: Data and Discussion of the State of the Clinical Research Site Room 178 #204: Diversity and Inclusion in Clinical Trials: Concrete Strategies for Enhancing Health Equity Room 179 #205: Optimizing Evidence Supporting Fit-for-Purpose Digital Clinical Measures Across the Drug Development Life Cycle Room 180 #206: The Future of Content Authoring and Web Portal Technology, Publishing Stability Calculators: Challenges for Pushing Automation Room 470 B #207: Enhancing Interactions Among Stakeholders to Advance Patient-Focused Drug Development: Landscape of Current Activities Room 183 C #208: Keeping Passion for Project Management Alive Room 470 A

9:15am CDT

#209: New EU Clinical Trial Regulation: Experience So Far Room 184 #210: Challenges of Translational and Early-Phase ASO Development Room 183 B #211: Shifting the Audit Paradigm for a More Effective Outcome Room 186 #212: Where Are We with Antimicrobial Resistance (AMR) in the Regulatory Space? Room 185 AB #213: Reflections on PDUFA: A Look Back at PDUFA VI and A Preview of PDUFA VII Room 187 #214: New Policy Developments in Combination Products Room 185 CD #215: Efforts Toward Global Convergence of CMC and GMP Expectations Room 183 A

10:00am CDT

Coffee Break Exhibit Hall

10:20am CDT

#216 IT: Clario Innovation Theater: Decentralized Clinical Trials - Real Solutions in Real-Time Exhibit Hall Theater #2 #217 IT: Flatiron Health Innovation Theater: Leveraging Access at the Point of Care and Next-Generation Electronic Source (eSource) Technology to Accelerate Clinical Research Exhibit Hall Theater #1 #218 IT: Twilio for Life Sciences Innovation Theater: Delivering Personalized Experiences through Omnichannel Engagement Exhibit Hall Theater #3

11:00am CDT

#219: Post-Approval Safety Studies: Approaches to Assessing Medication Exposure and Potential Safety Risks During Pregnancy Room 176 #220: Collection of Quality Endpoint Data in a Decentralized Trial in Complex Indications: The Practical and Logistical Challenges Room 180 #221: Complying with the EU-CTR Disclosure Standards in the Era of GDPR Room 470 B #222: Patient-Focused Drug Development: Reflecting on a Decade of Insights Room 183 A #224: ICMRA Update: Convergence and Collaboration on COVID-19 - Learning from the Present for the Future Room 179 #223: Meeting Regulatory Expectations: What Needs to be Considered When Using Digital Technologies to Generate Clinical Evidence? Room 175 #225: Solving for ‘Shared Value’ of Cell and Gene Therapy with Real-World Evidence in the Post-Pandemic Healthcare Ecosystem Room 178

11:15am CDT

#227: Approaching the Assessment of Clinical Protocol Complexity Room 183 C #226: Simulating Trial Activities with Patients: Our Experiences Room 185 CD #228: Individualized Therapeutics: Walking the Line Between Research and Treatment Room 183 B #230: Asia Town Hall Room 186 #229: Accelerating Cell and Gene Therapy Development Through International Regulator Collaboration Room 185 AB #231: Leveraging Real-World Evidence for Regulatory Purposes Room 187 #232: Preparing for the Future of Research and Development:10-Years of Multistakeholder Innovation, Collaboration, and Transformation Room 184

12:00pm CDT

#02 POS: Poster Session II Level 3 F2 Entrance Luncheon Service Exhibit Hall Community Networking Lunch Exh Hall Community Area

12:25pm CDT

#233 IT: JMP Statistical Discovery Innovation Theater: Interactive Safety Assessment Reports to Aggregate, Filter, and Subgroup Clinical Trial Data Exhibit Hall Theater #2 #234 IT: Labcorp Innovation Theater: The Labcorp Patient Recruitment Ecosystem - Designing a Better Clinical Trial Experience Exhibit Hall Theater #3 #235 IT: Veeva Innovation Theater: Clinical Trials Prepare for a Digital, Connected Future Exhibit Hall Theater #1

12:30pm CDT

#237 RT : Round Table Discussion: Individualized Therapeutics: Walking the Line Between Research and Treatment Room 375 A Zone 2 #236 RT: Round Table Discussion: FDA Update on the Upcoming PDUFA VII Data and Technology Commitment Room 375 A Zone 1

12:45pm CDT

#237.2 CH: Location, Location, Location: Building the Next Generation of Community-Based Clinical Trial Site Networks Room 470 A #237.1 CH: Emerging Editorial Policies, Researcher, and Author Standards in Promoting Diversity, Inclusion, and Equity in Cancer Research Room 470 B #003 STU: Career Ladder or Career Lattice? Strategies for Career Development Room 471 A

1:05pm CDT

#238 IT: Precision for Medicine Innovation Theater: Bridging Clinical Operations and Translational Science to Meet Critical Endpoints in Precision Medicine Trials Exhibit Hall Theater #1 #239 IT: IQVIA Innovation Theater: Delivering Better Outcomes with Connected Intelligence Exhibit Hall Theater #2 #240 IT: Microsoft Innovation Theater: The New Reality of Work in Pharma - How Mixed Reality is Modernizing Operations, Accelerating Research and Improving Patient Engagement Exhibit Hall Theater #3

1:45pm CDT

#241: Drug Safety in Africa: New PV Horizons Room 178 #242: Risk Minimization for Health Products: What are we Learning for an Improved Path Forward Room 175 #244: Planning and Conducting Efficient, High-Quality Decentralized Trials: A Multi-Stakeholder Initiative Room 179 #243: Technology-Enabled Clinical Trials Using Electronic Health Record (EHR)-Derived Real-World Data: Opportunities and Limitations Room 176 #245: Understanding the Consumer's Journey for Information From Searching for Information to Using Information Room 180 #246: Project Management Across the Healthcare Continuum Room 470 B #247: Paying for Digital Health: What Evidence is Needed? Room 185 CD

2:00pm CDT

#248: Healthcare Datasets as Assets: Secure and Compliant Valuation and Transaction Methods Room 186 #249: Regulatory-Grade Real-World Evidence: Distilling to Practice Room 183 A #250: Patients as Central Partners in COA Design Room 183 C #251: Data Science, Text Analytics, and Machine Learning to Derive Insights from Clinical Quality, Compliance, and Real-World Data Room 183 B #252: International Collaborations: What’s New in Oncology? Room 184 #254: Overcoming Challenges in Pediatric Product Development Room 187 #253: Efforts to Improve Diversity of Clinical Trial Participants Room 185 AB #255: Demystifying Statistical Concepts for Non-Statisticians Involved with Clinical Trials Room 470 A

2:45pm CDT

Refreshment Break Exhibit Hall

3:00pm CDT

#256 RT: Round Table Discussion: Technology-Enabled Clinical Trials Using Electronic Health Record (EHR)-Derived Real-World Data: Opportunities and Limitations Room 375 A Zone 1 #257 RT: Round Table Discussion: Enhancing Interactions Among Stakeholders to Advance Patient-Focused Drug Development: Landscape of Current Activities Room 375 A Zone 2

3:10pm CDT

#258 IT: IBM Watson Health Innovation Theater: User Centricity in Clinical Data Management - The Next Revolution for eClinical Solutions Exhibit Hall Theater #2 #259 IT: UBC Innovation Theater: Modernizing Observational Research and Decentralized Studies with Patient Mediated Electronic Medical Record Release Exhibit Hall Theater #1 #260 IT : Appian Innovation Theater: Shape the clinical trials journey by bringing people, process and data together on a unified platform Exhibit Hall Theater #3

3:30pm CDT

#261 CH: How Drug Development Will Change Post-COVID Room 470 A #262 CH: Mentoring 101 Room 470 B

3:50pm CDT

#263 IT: Certara Innovation Theater: Optimizing Patient Narrative Technology - Automating the Complicated and Creating Efficiency Exhibit Hall Theater #1 #264 IT: Veeva Innovation Theater: Defining Digital Trials to Operationalize Decentralized Trials Exhibit Hall Theater #2 #265 IT: M-Files Innovation Theater: Does your Document Management System Support your Growth Trajectory? A Charles River Labs Story Exhibit Hall Theater #3

4:15pm CDT

Poster Showcase Session Room 471 A #267: Improving Safety Data Through Innovative Use of Technology Room 175 #266: FDA's Updates on Ensuring Post Market Safety and Surveillance for Generic Drugs Room 178 #268: Life Science Research Innovation Powered by Real-World Data Room 183 A #269: Strategic Planning in Selecting the Right Countries and Sites for Clinical Trials Room 183 C #270: Recommendations for Conducting Bring Your Own “Device” (BYOD) Clinical Studies Room 180 #271: Building the First Cloud-Based Submission Review Collaboration Platform Room 184 #272: Fit-for-Purpose Patient Preference Studies: Emerging Recommendations from IMI PREFER Room 186 #273: IMPALA (IntercoMPany quALity Analytics) Industry Group: Data Science Development and Other Collaboration Updates Room 470 B #274: Regulatory Convergence Successes and Opportunities Room 179 #275.1: PMDA Town Hall Room 183 B #275: How to Interact with Regulators to Qualify a Digital Mobility Outcome? Room 185 CD #276: Rethinking Fundamental ICH CMC Guidelines: Analytical Procedures, Stability, Specifications, and Risk Assessment Room 176 #277: Quantitative Benefit-Risk Approaches in Drug Development and Approval: Examples from FDA and Industry Room 185 AB #278: FDA Real-World Evidence Guidance for Regulatory Approval: Implications for Evidence Needs for Payers and Population-Based Decision Makers and Healthcare Providers Room 187 #279: Decision Making and Decision Science;: Learn to Make Better Business and Life Decisions from Patients that Used Decision Science Room 470 A

5:00pm CDT

DIA Publications Meet and Greet: Overview and Opportunities Room 471 A
 
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  • 00: Plenary
  • 01 - Clinical Safety and Pharmacovigilance
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Tech in Clinical Trials
  • 04: MedAffairs-SciComm
  • 05: Patient Engagement
  • 06: PreClinical Dev-EarlyPhaseCR
  • 06 - Translational Sciences and Precision Medicine
  • 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
    • Exh Hall Community Area
    Exhibit Hall
    Exhibit Hall Booth #1719
    Exhibit Hall Theater #1
    Exhibit Hall Theater #2
    Exhibit Hall Theater #3
    Level 3 F2 Entrance
    Meeting Rm Lobby Level 1
    Meeting Room Lobby
    Room 175
    Room 176
    Room 178
    Room 179
    Room 180
    Room 183 A
    Room 183 B
    Room 183 C
    Room 184
    Room 185 AB
    Room 185 CD
    Room 186
    Room 187
    Room 375 A Zone 1
    Room 375 A Zone 2
    Room 470 A
    Room 470 B
    Room 471 A
    Room Skyline 375 CDE
    Skyline Ballroom Foyer
    TBD
    Virtual