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8:00am • #304 L: Strategic Directions from Global Medicines Regulators: The ICMRA Statement on Combatting Antimicrobial Resistance
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8:00am • #306 L: Defining the Treatment Effect of Interest in Regulatory Submissions: Estimands and ICH E9R1 Final Guidance
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8:00am • #301 SL: Combining Multiple Real World Data Sources to Maximize Value
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8:00am • #304.1 L: ICH 30th Anniversary: Achievements and Future Prospects
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8:00am • #302 L: Seamlessly Evolving Global Clinical Trial Liaison Field Medical Resources to Classic MSLs from Phase 3 to Launch
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8:00am • #303 SL: Detection of Anomalies in eCOA Data and Metadata for More Pre-Emptive, Evidence-Based Risk Management
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9:00am • #307 SL-IT: Salesforce Innovation Theater: Recruit and Engage Trial Participants with a Connected Platform
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9:30am • #309 L: If You Build it, Will They Come? What’s Really Needed to Transform Information Flow in Clinical Development
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9:30am • #312 L: Pediatric Development: Can Increasing Collaboration Lead to Fewer Unnecessary Trials?
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9:30am • #310 L: Global Rare Disease Town Hall
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9:30am • #311 L: ICH 30th Anniversary Series: Advancing Pharmaceutical Safety
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10:45am • #313 SL-IT: UBC Innovation Theater: What You Need to Know About Assembling an Integrated Registry
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10:45am • #314 SL-IT: IQVIA Innovation Theater: Modernizing Regulatory Evidence with Real World Studies
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10:45am • #315 SL-IT: Microsoft Innovation Theater: Journey to the Fully Digital Study Starts with Standards
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11:30am • #318 L: Data Strategy and Privacy Compliance in the Age of Digital Health: GDPR, HIPAA, and CCPA Implications
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11:30am • #321 L: Recommendations for a Strategic Response to the COVID-19 Pandemic
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11:30am • #320 L: Advanced Therapy Medicinal Products: Facilitating Individualized Gene Therapies and Cell-Based Therapeutics
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11:30am • #316 SL: Report of CIOMS DILI Working Group
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11:30am • #319 L: Leading Through Complexity: Opportunities, Pitfalls, and Best Practices for Managing Successful Partnerships
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11:30am • #317 L: Evolving Trials for the Digital Age
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12:30pm • #618 NL: Networking Lounge: Real World Evidence
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12:30pm • #624 NL: Networking Lounge: Diversity, Disparities, and Inclusiveness
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12:30pm • #619 NL: Networking Lounge: COVID-19
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12:30pm • #623 NL: Networking Lounge: Data Science
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12:30pm • #620 NL: Networking Lounge: Patient Focused
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12:30pm • #617 NL: Networking Lounge: Emerging Professionals and Students
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12:30pm • #621 NL: Networking Lounge: Advanced Therapies
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12:30pm • #622 NL: Networking Lounge: Digital Technology and Artifical Intelligence
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12:45pm • #323 SL-IT: IQVIA Innovation Theater: Driving Quality Through Innovative Digital Trial Approaches in a Pandemic Era
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12:45pm • #322 L-RT: Round Table Discussion: Data Strategy and Privacy Compliance in the Age of Digital Health: GDPR, HIPAA, and CCPA Implications
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12:45pm • #324 SL-IT: JMP Innovation Theater: Adverse Events in Clinical Trials: When Doctors Require a Statistical Perspective
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1:15pm • #325 SL-IT: Covance Innovation Theater: Tailoring Your Journey Map Using a Data Driven Approach to Accelerate Patient Recruitment and Improve Patient Retention
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1:30pm • #329 SL-CH: The New DIA Statistics and Data Science Community
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2:00pm • #333 SL: Driving Quality Through Innovative Approaches
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2:00pm • #334 L: Best Practices for Virtual Meetings with FDA!
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2:00pm • #332 SL: Optimizing Communication with Patients to Support Meaningful Feedback into the Research Process
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2:00pm • #331 L: Globalization of Medical Information
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2:00pm • #330 L: Application and Validation of Intelligent Automation Technology in PV: Exploring Opportunities within the Individual ICSR Process
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3:15pm • #335 SL-CH: Role of Medical Communications Experts in Building Accelerated Regulatory Dossiers and Securing First-Attempt Approvals
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4:00pm • #338 L: Immunogenicity of Biologics: Clinical Consequences
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4:00pm • #342 L: Drug Pricing in the United States: How and Why is it Different Than in the Rest of the World
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4:00pm • #341 L: Using Data Monitoring Strategies in Detection of Data Anomalies and Trial Misconduct
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4:00pm • #340 SL: Approaches for Cross-Functional Teams to Enhancing Quality of Decision-Making During the Development and Review of Medicines
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4:00pm • #339 SL: The Development of Novel Digital Endpoints
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4:00pm • #343 L: Mindfulness: Beyond Meditation
