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Tuesday, June 29
 

8:00am EDT

#201 IT: WCG Innovation Theater: Tailored Preparation for Site Success and Trial Continuity - WCG Site Augmentation TBD #202 IT: Unqork Innovation Theater: Unqork for Clinical Trials TBD

9:00am EDT

#203 SS: Spotlight Symposia: Important Gaps to Fill with Diversity and Inclusion in Clinical Trials - Moving Beyond Recognition to Action TBD #204 SS: Spotlight Symposia: Tales from the Front: Patient Equity and Engagement in Practice from Trial Design Through Execution TBD #205 SS: Spotlight Symposia: Three Paths to Success in a Post-COVID World TBD

9:30am EDT

#206 CH L: Acceleration of Clinical Research by Simultaneously Leveraging Real-World and Clinical Trials Data TBD #209 IT: Medidata Innovation Theater: Engaging Patients Pre- and Post-trial with Registries TBD #207 IT: IQVIA Innovation Theater: Driving the Digitization of Clinical Development – Understanding the Impact of Innovative Digital Approaches TBD #208 IT: Oracle Innovation Theater: Untangling the Integration Mess of Today’s Digital eClinical TBD

10:00am EDT

#210 SL: Assuring Access to Safe Medicines in Pregnancy and Lactation: International Regulators Perspective TBD #211 SL: Managing Global Trials in Latin America: Covid Impact Update TBD #212 SL: Post COVID: Sites Evolving Role in the Clinical Trial Ecosystem TBD #214 SL: Developing a Best-in-Class Learning and Performance Program for the MSLs of Today and the Future TBD #215 SL: Pediatric Engagement in Research: Young People Have a Voice TBD #213 SL: Perspectives on Real-World Data/Evidence Collection Through Expanded Access During the Covid-19 Pandemic TBD #216 SL: Brave New World: Early Clinical Trials in a Pandemic TBD #217 SL: Project Management in Times of Crisis: Perspectives from PMs Supporting COVID-19 Related Projects TBD #218 SL: Novel and Innovative Approaches to Inspections: Verification of Quality and Compliance Using Remote Methodologies and New Technology TBD #219 SL: Advancing Medicines’ Regulation in Europe: Key Strategies to 2025 TBD #220 L: Office of Generic Drugs and Office of Pharmaceutical Quality Generics Town Hall TBD #221 SL: Global Harmonization of Complex and Innovative Trial Designs TBD

11:00am EDT

#222 CH L: Patient-Reported Outcomes: Going Beyond Clinical Trials TBD #223 IT: PPD Innovation Theater: Capacity Management Through Upheaval TBD #224 IT: Syneos Health Innovation Theater: Partnering to Innovate - The Way Forward for Decentralized Clinical Trials TBD #253 IT: Generis Innovation Theater: Optimizing Regulatory Affairs with Structured Content Authoring TBD

11:30am EDT

#225 SL: International Coalition of Medicines Regulatory Authorities (ICMRA): Harnessing Achievements During COVID-19 for the Future TBD

12:00pm EDT

#225.1 NTW: How to Ensure Quality in Cell and Gene Therapies TBD

12:30pm EDT

#227 IT: Quest Diagnostics Innovation Theater: Healthcare Analytics Solutions, LeveragingPatient-Centric Data to Empower Pharmaceutical Organizations and CROs TBD #228 IT: Certara Synchrogenix Innovation Theater: Medical Writing and Submission Compilation Made Easy - Technology Solutions from Regulatory Experts TBD #226 IT: Statistics & Data Corporation (SDC) Innovation Theater: Artificial Intelligence and Machine Learning - Infrastructure and Team Architecture Enabling Efficient Capabilities TBD

1:00pm EDT

#229 RT L: Round Table Discussion: Implicit Bias in Early Phase Clinical Trials: The Sociocultural Implications of Advancing the Science TBD

1:15pm EDT

#231 IT: Parexel International Innovation Theater: A Collaborative Trial Delivery Platform to Expedite Research TBD #230 IT: ERT Innovation Theater: Check Your Blind Spots: A Holistic Approach to Patient-Centric Decentralized Clinical Trials TBD

1:30pm EDT

#233 CH L: The Clinical Impact of Medical Information for Healthcare Professionals TBD #235 SC L: Solution Circle: Conducting Clinical Trials in China TBD

2:00pm EDT

#236 L: Systems Thinking: A Better Way of Safety Management Planning TBD #237 SL: Diversity in Clinical Research: Practical Strategies for Taking Personal Action TBD #238 SL: Are External Control Arms Ready for Primetime? TBD #241 SL: Opportunities for Harmonization of Clinical Trial Information in Regulatory Documents TBD #242 L: Navigating Non-Trial Preapproval Access as a Patient TBD #243 SL: Epigenetic Drugs: Taking it to the Clinic- An Up-and-Coming Mode of Targeting Disease TBD #244 SL: How to Stay Grounded in Project Management Best Practices While Moving at the Speed of Light Integrating a New Company TBD #245 SL: GCP Quality and Compliance: The Regulator’s Perspective TBD #239 L: Quality by Design for Clinical Trials: A Hands-On, Multi-Stakeholder Workshop TBD #246 SL: Global Regulatory Harmonization for Increased Patient Access to Medicines Through the International Council for Harmonisation (ICH) TBD #248 L: Supporting Quality/CMC Development in Early Access Approaches (PRIME/Breakthrough Designation) TBD #249 SL: Innovative Statistical Strategies and Designs in Oncology Drug Development TBD #250 SL: How Can Real-World Evidence be Communicated Compliantly to Payers or Healthcare Providers? TBD #240 SL: Driving Change Globally: Transforming the Regulators as Early Digital Adopters TBD #247 SL: Update on FDA's Real-World Evidence Program: Current FDA Demonstration Projects TBD

3:00pm EDT

#250.1 RT L: Round Table Discussion: FDA Perspectives on Modernization of Clinical Trials: Clinical Practice Data, Decentralized Trials, Digital Health Technologies TBD #251 RT L: Round Table Discussion: Advancing Medicines’ Regulation in Europe: Key Strategies to 2025 TBD #251.1 NTW: Patient Scholar Meet Up TBD #252 SS: Spotlight Symposia: Managing Stakeholders in the Decentralized and Hybrid Clinical TrialEcosystem TBD #252.1 SS: Spotlight Symposia: Requirements of Site Training Technology in the New Research Landscape TBD

3:15pm EDT

#232 IT: DocuSign Innovation Theater: Maintain Compliance While Serving a New Generation of Digital-First Customers TBD #254 IT: Deloitte (ConvergeHEALTH) Innovation Theater: Using AI to Drive Clinical Data Automation TBD #254.1 IT: Labcorp Drug Development Innovation Theater: ICYMI - Game on! How Gamification Drives Engagement in Pediatric and Adolescent Clinical Trials TBD

4:00pm EDT

#255 SL: Treating Covid-19 Patients with Unproven Interventions Outside Trials: EUAs, Expanded Access, Right to Try, and Off-Label Use TBD #256 SL: Innovative and Efficient Trial Designs and Statistical Approaches in Small Patient Populations: Rare Diseases and Pediatrics TBD #258 SL: Effective Medical and Scientific Stakeholder Engagement: Are Digital Solutions The Answer? TBD #259 SL: Parents Just Don’t Understand: Does This Apply to Healthcare Too? TBD #260 SL: What Do We Do Now? Why You Need A Resource for Ethical Questions During Drug Development TBD #261 SL: Innovative Approaches to Trial Execution, Quality, and Compliance TBD #262 SL: Frameworks for Digital Endpoints via the IND Pathway TBD #263 SL: Pandemic Preparedness: Accelerating Treatments to Overcome Antimicrobial Resistance TBD #257 SL: Is There a Role for Federal Incentives to Stimulate Greater Diversity in Clinical Trials? TBD #264 SL: Multinational Collaborative CMC Review for Efficient and Rapid Product Approval TBD #265 SL: A Regulatory/Industry Panel on Estimands: Alignment of the Clinical Objective, Trial Design, Analysis, and Interpretation TBD
 
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  • Filter By Venue Virtual Meeting
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  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Data Standards
  • 04: MedAffairs-SciComm
  • 05: Patient Engagement
  • 06: PreClin Dev-EarlyPhaseCR
  • 07: ProjMgt-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: Posters
  • 18: Networking Opportunities
  • 19: Short Courses
  • 20: Early Access Content
  • 21: InnovationTheaters
  • 22: Solution Circles
  • 23: Spotlight Symposia
  • 24: Lunch-and-Learn
  • Beginner
  • Featured Topics
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TBD
Virtual Event
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Data Standards
  • 04: MedAffairs-SciComm
  • 05: Patient Engagement
  • 06: PreClin Dev-EarlyPhaseCR
  • 07: ProjMgt-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: Posters
  • 18: Networking Opportunities
  • 19: Short Courses
  • 20: Early Access Content
  • 21: InnovationTheaters
  • 22: Solution Circles
  • 23: Spotlight Symposia
  • 24: Lunch-and-Learn
  • Beginner
  • Advanced
  • Beginner
  • Intermediate
  • Featured Topics
  • Artificial Intelligence
  • Collaboration
  • COVID-19 - Pandemic
  • Digital Technology
  • Diversity Equity and Inclusion
  • HTA
  • Innovative Trial Design
  • Novel Therapeutic Approaches
  • Patient Focused
  • Regulator Thinking
  • RWD-RWE
  • Special Populations
  • Student Programming
  • What's Next