Loading…
Attending this event?
arrow_back View All Dates
Wednesday, June 22
 

8:00am CDT

Coffee Service Meeting Rm Lobby Level 1

9:00am CDT

#301: Uses of Artificial Intelligence for PV in the Context of COVID 19 Room 178 #302: Mission-Driven Research Partners: How Patient Advocacy Organizations Can Help Advance Your Therapeutic R&D Programs Room 176 #303: Grappling with Uncertainty: Pediatric Gene Therapy Trials and Ethics Room 470 A #304: Transformation of the Data Manager to the Data Scientist Room 470 B #305: What’s New at ICH? From the E11A Pediatric Extrapolation Guideline to Model Informed Drug Development (MIDD) Room 175 #306: Leveraging Best Practices and Tools from the Discipline of Project Management to Uphold Quality, Protect Patient Safety, and Optimize Financial Budgets in a World of Complexities Room 183 C #307: Improve the Speed and Cost of Clinical Trials With Bayesian Approaches: Unpacked for Non-Statisticians Room 180

9:15am CDT

#308: Community and Patient Engagement: Putting Research into Context Room 183 B #309: Pharmacovigilance Quality: Key Considerations Room 187 #310: BsUFA III and GDUFA III: Increasing FDA’s Authority to Enhance Competition Room 185 AB #311: Ahead of Analyses: Planning, Designing, and Pre-Specifying Observational Studies Room 185 CD #312: COVID-19 360°: Embedding Global Best Practices in Routine Regulatory Action and Preparing for the Next Pandemic Room 184 #313: China Town Hall Room 186

10:00am CDT

Coffee Break Exhibit Hall

10:20am CDT

#314 IT: Datacubed Health Innovation Theater: How Innovations in ePRO Are Powering Better Patient Engagement Exhibit Hall Theater #1 #315 IT: RxTROSPECT Innovation Theater: Oncology - Expediting Strategy Exhibit Hall Theater #2 #316 IT: ATCOR Medical Innovation Theater: Non-Invasive Central BP Monitoring - Improving Efficiency and Success of Drug Development Exhibit Hall Theater #3

11:00am CDT

#317: Let’s Make a PV Agreement: Four Solutions You Can Use to Enhance Your Entire PVA Process Room 175 #318: Rare Disease Data Sharing: A Value Proposition Room 178 #319: Ensuring Diversity in Clinical Trials Room 179 #321: FHIR in Clinical Research Room 180 #320: De-Risking Decentralized: Understanding the Dimensions of Risk and Maximizing Data Quality in Decentralized Trials Room 176 #322: Risky Business – The Sequel: Successfully Manage Program-Level Risk Room 470 A #323: Remote GMP Assessments, Inspections and Audits : Here to Stay? Room 186

11:15am CDT

#324: The Value of Medical Writing: The Regulator's Perspective, Development of Professional Medical Writers as Successful Leaders Room 183 C #325: Assessing and Integrating Patient Preferences into Treatment and Clinical Trial Design Room 183 A #326: China’s Biopharma Innovation Landscape and Trends Room 187 #327: New Approaches to Inspections Room 185 AB #328: Approaches to Health Authority Collaboration: Are They Fit-for-Purpose and How Should They Evolve Post-Pandemic? Room 183 B #329: Complex Innovative Design: What’s in Name? A Global Perspective on the Changing Design Landscape Room 185 CD #330: Leveraging Real-World Evidence to Address Diversity Gaps in Randomized Clinical Trials: Regulatory, Clinical, and Other Considerations Room 184

12:00pm CDT

Luncheon Service Exhibit Hall

12:25pm CDT

#331 IT: IQVIA Innovation Theater: Real World Evidence (RWE) to Enhance Clinical Development Exhibit Hall Theater #1 #332 IT: Deloitte Innovation Theater: Ushering in Next-Gen Regulatory Intelligence Exhibit Hall Theater #2 #333 IT: Curebase Innovation Theater: Learning by Doing - An Analysis of a Curebase DCT Patient Experience Exhibit Hall Theater #3

12:30pm CDT

#334 RT: Round Table Discussion: The Value of Medical Writing: The Regulator's Perspective, Development of Professional Medical Writers as Successful Leaders Room 375 A Zone 1 #335 RT: Round Table Discussion: Value of Patient Experience Data in Healthcare Decision-Making Room 375 A Zone 2

12:45pm CDT

#336 CH: Reviewing FDA's Draft Guidance on PROs in Oncology Trials: How This Affects Future Measurement Strategy and Study Designs Room 470 B #005 STU: Hashtag Your Way to a Job: How to Use Social Media to Promote Yourself and Start Your Career Room 471 A

1:05pm CDT

#337 IT: Yseop Innovation Theater: Automate Medical Writing with Artificial Intelligence (AI) Exhibit Hall Theater #3 #338 IT: Evernorth Innovation Theater: Trends in Behavioral Health - Effects of Telehealth, Medications, and Outpatient Treatment on Total Cost of Care Exhibit Hall Theater #2 #339 IT: Parexel Innovation Theater: FSP Futureview - Building Infrastructure and Talent for a Flexible Future Exhibit Hall Theater #1

1:45pm CDT

#340: Monitoring COVID-19 Vaccine Safety Room 178 #342: Democratizing Data for Cancer Research and Real-World Evidence Generation Room 176 #341: New Approaches to Site Selection in Clinical Trials Room 175 #343: Redefining the Value Proposition for Innovation: Connecting Data, Technology, and Quality to Improve Outcomes Room 179 #344: Managing Up and Managing Down: Developing and Advocating for Your Medical Writing Team Room 470 A #345: Statistical Issues in Master Protocols: Beyond Type I Error and Concurrent Controls Room 180 #346: New Global Team: Building and Leading Remote Teams and Non-Fulltime Equivalents (FTEs) Room 470 B

2:00pm CDT

#347: Enabling Digital Transformation in Health Care and Clinical Trials Room 184 #348: Research and Innovation to Enhance Patient Access to Topical Dermatological Products in the US Room 185 AB #349: The Power and Uncertainty of Data: How it Can be Used to Drive Efficiency While Recognizing its Limitations Room 186 #350: The Transformation of Quality Assurance: The Roadmap Room 185 CD #351: Health Canada Town Hall Room 183 A #352: FDA Rare Disease Town Hall Room 187 #353: Planning for the Worst: Approaches for Drug Shortage Avoidance Room 183 B #354: How Can Population Decisions Makers and Pharmaceutical Companies Engage Collaborative Research? Room 183 C

2:45pm CDT

Refreshment Break Exhibit Hall

3:00pm CDT

#355 RT: Round Table Discussion: Mission-Driven Research Partners: How Patient Advocacy Organizations Can Help Advance Your Therapeutic R&D Programs Room 375 A Zone 1 #356 RT: Round Table Discussion: Planning for the Worst: Approaches for Drug Shortage Avoidance Room 375 A Zone 2

3:10pm CDT

#357 IT: Labcorp Innovation Theater: Transforming the Patient Experience in Decentralized Clinical Trials Exhibit Hall Theater #3 #358 IT: Axiom Innovation Theater: Saving Patient Lives – The Value of Time Exhibit Hall Theater #1 #359 IT: Calyx Innovation Theater: Meeting Regulatory Expectations on IRT Data Ownership Exhibit Hall Theater #2

3:15pm CDT

#360 CH: Considerations for Establishing Meaningful Change for Digital Endpoints Derived From DHT Drug Development Tools Room 470 A #361 CH: Separating the AI Hype From Reality: A Primer on NLP (Natural Language Processing) Room 470 B

3:50pm CDT

#362 IT: PointClickCare Innovation Theater: LTPAC EHR Data - Patients Included! Exhibit Hall Theater #1 #363 IT: ZS Innovation Theater: Shaping the Future of Clinical Development - A Novel Approach for Today’s Siloed Model Exhibit Hall Theater #3 #364 IT: Florence Healthcare Innovation Theater: Design Better Trials with Always-On Connectivity to Sites - A Case Study Exhibit Hall Theater #2

4:15pm CDT

#365: Field of Dreams: If We Build it, Will they Come? Using Implementation Science to Improve Digital Risk-Minimization Tools Room 175 #366: Development of Standard Core Sets of Clinical Outcome Assessments and Related Endpoints Room 178 #367: Local Conduct for Global Clinical Trials: Focus on Japan, Latin America, and Africa Room 176 #368: Sneak Peak: First Share from Initiatives of a Global Collaboration to Address Barriers to Decentralized Trial Scale and Adoption Room 183 A #370: Where Are we Really on Data Interoperability? Room 185 AB #369: Approaches to Addressing Diversity and Inclusion in Clinical Research Room 185 CD #371: Reimbursement, Compensation, and Incentives: Best Practices for Payments to Research Participants Room 180 #372: Accelerating Innovation Through Investing Room 186 #373: Effective Oversight Strategies of CROs and Digital Technology Vendors: How to Comply with Health Authority Expectations Room 183 B #374: Around the World: Regulator Perspectives on Decentralized Clinical Trials Room 184 #375: The Global Impact of ORBIS: Case Studies and Perspectives Room 187 #376: How to Manage Device Design Changes Under EU MDR Room 183 C #377: Choosing the Most Convincing Clinical Endpoints in Cancer Clinical Trials: How to Balance Different Perspectives? Room 470 B #378: US Health Care System Adoption of a Class of New Technologies for the Treatment of Alzheimer’s Disease: Access Challenges and Opportunities Room 179 #379: Search Within: Maximize your Strengths and Possibilities Room 470 A
 
Filter sessions
Apply filters to sessions.
Filtered by Date - 
Clear filter
Monday, June 13
Tuesday, June 14
Wednesday, June 15
Thursday, June 16
Monday, June 20
Tuesday, June 21
Wednesday, June 22
Thursday, June 23
Monday, June 12
Tuesday, June 13
Wednesday, June 14
Monday, June 26
Tuesday, June 27
Wednesday, June 28
Thursday, June 29
  • 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