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Monday, June 26
 

10:45am CDT

Artificial Intelligence: Delivering on the Promise TBD Risk-Based Monitoring in Clinical Trials: A Four Year Analysis TBD Sponsor-CRO Collaborations and the Impact of Decentralized Clinical Trials TBD Inspired by Big-Tech and Humbled by Complexity of Clinical Research: Clinical Trial Digital Transformation TBD What’s in the Future for Global Advancements in Patient Engagement and Patient-Focused Medical Product Development? TBD New Alternative Methods-Only IND Application: Distant Dream or Immediate Possibility? TBD ICH E6 R3 Forum: Highlights of What's new and What Changed Regarding Sponsor Responsibilities TBD Cell and Gene Therapies Pulse Check TBD Diversity and Inclusion Implications for Global Regulatory TBD E9(R1) Implementation: Practical Applications of Using Estimands in Protocols, SAPs, Data Standards in Clinical Trials and NDA/BLA Submissions to FDA TBD Applying Implementation Science Methods to Generate Evidence to Improve Access to New Therapeutics: What has Been Learned? TBD Negotiating your Next Offer TBD

1:30pm CDT

Enhancing the Quality of Safety Data Collection TBD Can We Further Innovate Clinical Trial Designs? Lessons Learned and Future Opportunities TBD Patient-Reported Outcome Measures to Support Oncology Clinical Development and Labeling: Responding to FDA’s Draft Guidance TBD Building Trust: Data Privacy in Decentralized Clinical Trials TBD Innovative Digital Health Technologies: Strategies for Successful Integrations, Quality, and Compliance TBD Consent is the Oil of Customer Engagement: How to Keep the Omnichannel Engine Running TBD Patient Involvement Optimizes Clinical Protocol Design: Real-World Experiences and Insights TBD Contemporary Challenges in Personalized Medicine and Companion Diagnostics TBD Unleashing the Fearless Quality Professional TBD Combating Misinformation with Authoratative Medical Product Information TBD Novel Biomarkers and Surrogate Endpoints in a Rare Disease TBD WHO Town Hall: The New Era of WHO Listed Authorities (WLAs), Reliance in Action, and Country and Regional Focus for Regulatory Systems Strengthening TBD International Collaboration for Pharmaceutical Quality and Manufacturing Agility TBD Advances in Real-World Evidence: Randomized Clinical Trials Duplicate, Publication Scandal, and China’s Real-World Evidence Heaven TBD Do Surrogate Endpoints Expedite or Hinder Payer Coverage of Drugs? TBD

4:15pm CDT

Utilizing Wearable Biosensors to Better Manage Patient Safety During Immuno-Oncology Studies TBD Enabling the Use of Randomized Pragmatic Studies to Generate High Quality Real-World Evidence for Regulatory Decisions TBD What Patients and Care Partners are Saying about Hybrid and Decentralized Trials TBD Digital Endpoint Qualifications in Clinical Trials: Collaborations and Applications TBD The True Decentralization of Clinical Trials: Benefits and Drawbacks of Blockchain Technology TBD Best Practices in Effective Gathering of Medical Information Industry Insights TBD How to Assess and Implement Patient Preferences in Decision-Making Along the Medical Product Life Cycle? TBD What's Next in Precision Medicine? Translational Strategies for Dose Optimization in the Age of Project Optimus TBD One Year On: How Quality Briefs are Transforming the Approach to Quality and Driving Innovation to Serve Patients TBD Emerging Therapies and Technologies and Leveraging Opportunities for Engaging with Medicine Regulators to Support Innovation TBD Regulatory Cooperation, Coordination, and Reliance in Times of Crisis: The ICMRA Role TBD The Promise of Vaccine Platforms to Advance Regulatory Science: Where are we Now, Where are we Going, and How do we get There? TBD Challenges in Analytical Development of Cell and Gene Therapy Products, Regulatory Perspectives, and Convergence TBD Supporting Providers in Value-Based Contracts: Machine Learning and Recursive Neural Networks for Outcomes and Treatment Journey Optimization TBD Creating your Career Plan 101: A Practical Workshop TBD
 
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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
  • 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
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Featured Topics
  • AI and Machine Learning
  • COVID-19
  • Data Science
  • Decentralized Trials
  • Digital
  • Diversity Equity and Inclusion
  • Innovative Trial Design
  • Patient Perspective
  • Personalized Health Care
  • Regulator Perspective
  • Remote Work
  • RWD-RWE
  • Special Populations
  • Student Programming