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8:00am • #203 L: ICH 30th Anniversary Series: The Role of Multidisciplinary Topics
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8:00am • #204 L: Implementing Quality by Design for Clinical Trials: New Tools, Case Studies, and Multi-Stakeholder Discussion
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8:00am • #206 L: Regulatory Agility During the COVID-19 Pandemic
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8:00am • #202 L: Novel Approaches to Study Prevalent Chronic Diseases as Alternatives to Large-Scale Clinical Trials
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8:00am • #201 L: Patient-Centricity: How do We Measure Progress in Involving Patients in Drug Development and Drug Safety?
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8:00am • #205 SL: Using Artificial Intelligence to Inform Regulatory and Development Strategies
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9:00am • #208.1 SL-IT: IBM Innovation Theater: New Ways to Apply Decentralized Trials During Covid-19
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9:00am • #208.2 SL-IT: Covance Innovation Theater: Managing Complexity: The COVID-19 Road To Recovery and Restoration
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9:30am • #209 L: Data Driven Monitoring Enabled Through Analytics and Quality Risk Management
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9:30am • #212 L: Qualitative, Quantitative, and Mixed Method Approaches to Capture the Patient Experience
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9:30am • #214 L: GCP Quality and Compliance: The Regulators’ Perspective
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9:30am • #213 L: Project Management in Times of Crisis
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9:30am • #215 L: ACTIV: A Public-Private Partnership to Speed COVID-19 Therapies and Vaccines
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9:30am • #210 SL: Clinical Electronic Structured Harmonized Protocol (CeSHarP): ICH M11 - Status Update
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9:30am • #211 L: Balancing Clinical Trial Disclosure and Transparency With Global Data Protection Regulations
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10:45am • #219 SL-IT: Google Innovation Theater: Next Generation Biomedical and Clinical Research Platform with Google Cloud and Deloitte
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10:45am • #216 L-RT: Round Table Discussion: Patient-Centricity: How Do We Measure Progress in Involving Patients in Drug Development and Drug Safety?
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10:45am • #217 SL-IT: ArisGlobal Innovation Theater: The Evolving Role of CTMS in Risk Management
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10:45am • #218 SL-IT: Veeva Innovation Theater: The Next Big Step Toward a Collaborative Clinical Ecosystem
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11:30am • #225 L: Accelerated Approval and Emerging Surrogate Endpoints
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11:30am • #221 L: Non-Traditional Clinical Trials Require a Non-Traditional Workforce
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11:30am • #224 SL: Sponsor and Regulator Challenges, Risks, and Mitigation Strategies for Ensuring Third-Party Oversight of Vendors: Is Your Study Data at Risk?
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11:30am • #222 L: Patient-Centricity: How Do We Talk to and Listen to Patients?
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11:30am • #220 L: Disruptive Transformation in Safety Organizations
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11:30am • #223 L: Next Generation Analytics: Harnessing the Power of Nonclinical SEND Datasets to Improve Success in Early Clinical Development
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12:30pm • #609 NL: Networking Lounge: Real World Evidence
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12:30pm • #614 NL: Networking Lounge: Advanced Therapies
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12:30pm • #610 NL: Networking Lounge: COVID-19
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12:30pm • #616 NL: Networking Lounge: Diversity, Disparities, and Inclusiveness
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12:30pm • #613 NL: Networking Lounge: Digital Technology and Artifical Intelligence
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12:30pm • #612 NL: Networking Lounge: Emerging Professionals and Students
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12:30pm • #615 NL: Networking Lounge: Data Science
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12:30pm • #611 NL: Networking Lounge: Patient Focused
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12:45pm • #228 SL-IT: Bioclinica Innovation Theater: Rescuing Clinical Adjudication Studies - Special Considerations When Transitioning From an Under-Performing Adjudication Provider
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12:45pm • #226 SL-IT: Intersystems Innovation Theater: Investing in Real-Time, Real World Data to Accelerate Clinical Trials and Enhance Market Access
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1:15pm • #229 L-RT: Round Table Discussion: RIM Working Group Update
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1:30pm • #230 SL-CH: Staying Connected in a Virtual World: Communications Stakeholder Engagement That Drive Results
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1:40pm • #230.2 SL-IT: ConvergeHEALTH by Deloitte Innovation Theater: The Future of Clinical Trials is Now- How Can Digital Transformation Enable More Seamless Recruitment, Increase Patient Engagement, and Improve Adherence and Outcomes?
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2:00pm • #235 SL: Examining Diversity in Clinical Trials
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2:00pm • #238 SL: Utilizing Cloud-Based Platforms in Regulatory Contexts
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2:00pm • #233 L: Practical Considerations for Robust Evaluation of Risk Minimization Programs: Regulatory, Industry, and Service Provider Insights
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2:00pm • #237 L: Patient Voice and Its Role In Bringing Meaningfulness into Selection of Clinical Outcome Measures
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2:00pm • #234 SL: Practical Solutions for Designing and Conducting a Digital Health Trial
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2:00pm • #239 L: The FDA Complex Innovative Trial Design Pilot Program: Case Examples
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2:00pm • #236 L: FDA Data Standards Update
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3:15pm • #245 SL-IT: Parexel and Microsoft Innovation Theater: #KeepingPatientsFirst - An Integrated Research Platform for COVID-19
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3:15pm • #242 L-RT: Round Table Discussion: Examining Diversity in Clinical Trials
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3:15pm • #241 SL-CH: A Risk-Based Approach to Implement Audit Trail Review and Inspection Readiness Plans in a Data Integrity Conscious World
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3:15pm • #244 SL-IT: Veeva Innovation Theater: It's Time to Rethink Your EDC
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3:15pm • #240 L-SB: On the Soapbox: At a Time of High Priced Medicines and a Global Pandemic - How Do We Make Medicines Accessible and Affordable to All?
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4:00pm • #246 SL: FDA Pre-Market Safety Assessment Program
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4:00pm • #248 L: Incorporating the Patient Perspective in a Drug Development Program
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4:00pm • #249 L: Dynamic Multi-Disciplinary Collaboration for Aggregate Product Safety Assessment and Benefit-Risk Planning
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4:00pm • #247 SL: Engaging Caregivers in Research and Medical Product Development
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4:00pm • #250 L: Projecting a Voice of Confidence in a World of Uncertainty
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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
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8:00am • #401 L: Digital Risk Minimization: How Can We Advance Adoption?
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8:00am • #402 L: FDA Perspectives on Modernization of Clinical Trials: Real World Evidence, Decentralized Clinical Trials, and Digital Health Technologies
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8:00am • #406 SL: FDA-PAHO: Landscape Report of Regulatory Situation in the Americas
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8:00am • #405 L: Catalyzing the Integration of Digital Technologies in Healthcare Solutions
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8:00am • #404 L: Incorporating Patient Input into Medical Product Development and the US Food and Drug Administration’s Decision-Making
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8:00am • #403 L: Best Practices in Developing Medical Information Responses
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8:00am • #410 SL: Statistical Considerations for Using External Controls in Clinical Trials
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9:30am • #415 SL: Opportunities and Challenges for Real World Data and Real World Evidence: Dive Into the Details
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9:30am • #414 SL: ICH 30th Anniversary Series: International Harmonization for Pharmaceutical Quality
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9:30am • #412 L: Telling Health Stories for Drug Development
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9:30am • #413 L: Orphan Drug Development in Personalized Medicine
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9:30am • #416 L: Trust: What Makes It: What Breaks It
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9:30am • #411 L: Qualification and Oversight in Decentralized Trials: Practical Considerations for Clinical Operations and Quality Oversight
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10:30am • #417 SL-CH: Information Overload: Best Practices to Manage Information and Remember Where the Information Is!
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11:30am • #421 L: Quantitative Benefit-Risk Assessment: What Methods are Being Used? How Far has Industry Come?
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11:30am • #422 L: How the FDA’s MyStudies Platform is Accelerating the Use of Digital Technology in Clinical Research and Clinical Trials
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11:30am • #423 L: Reusing What You Wrote the First Time: Deja Vu All Over Again
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11:30am • #424 L: Keep Calm and Carry On: Mindfulness to Increase Work Productivity
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2:00pm • #431 L: FDA Town Hall
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5:00pm • #507 OD: ON DEMAND - Managing Global Clinical Trials in Emerging Regions: Latin America
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5:00pm • #522 OD: ON DEMAND - Online Medical Information Resources and Channels
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5:00pm • #524 OD: ON DEMAND - Storyboarding for Key Message Alignment in Marketing Applications
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5:00pm • #502 OD: ON DEMAND - Unblinding The New Face of the Local Safety Officer
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5:00pm • #511 OD: ON DEMAND - Design and Implementation of Multiregional Clinical Trials (MRCT) Using ICH E17 Guidelines
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5:00pm • #567 OD: ON DEMAND - Real World Use of Real World Evidence
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5:00pm • #555 OD: ON DEMAND - Updates of Drug Evaluation and Inspection in China
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5:00pm • #541 OD: ON DEMAND - Electronic Informed Consent: Global Perspectives
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5:00pm • #564 OD: On DEMAND - Communicating Value to Payers Pre-Approval in the US
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5:00pm • #539 OD: ON DEMAND - Revolutionizing Project Management Through Building Your Culture and Emotional Intelligence
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5:00pm • #516 OD: ON DEMAND - Deploying Machine Learning in Data Management
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5:00pm • #538 OD: ON DEMAND - Project Management Playbook to Effective Stakeholder Management
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5:00pm • #528 OD: ON DEMAND - Communicate and Co-Create with Patients Across the Medicines Development Lifecycle: Principles and Best Practices
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5:00pm • #551 OD: ON DEMAND - Advancing Clinical Trial Innovation Through Model-Informed Drug Development
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5:00pm • #553 OD: ON DEMAND - What Makes Real World Data Trustworthy: A Focus on Design and Data
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5:00pm • #566 OD: ON DEMAND - Subscription Models to Incentive Antimicrobial Innovation
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5:00pm • #550 OD: ON DEMAND - PMDA Town Hall: The Path of a New Chief Executive Since His Appointment
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5:00pm • #521 OD: ON DEMAND - Data Related International Policy and Strategy: EVDAS, E2B (R3), GDPR
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5:00pm • #544 OD: ON DEMAND - Pharmacovigilance Inspections: Leveraging Inspection Intelligence as a Driver of Quality in Your Organization
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5:00pm • #558 OD: ON DEMAND - Quality Considerations for Complex Drugs
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5:00pm • #510 OD: ON DEMAND - Journey of TMF Reference Model in Driving Inspection Readiness: The Decade's Impact, the Evolution to Come
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5:00pm • #505 OD: ON DEMAND - Older People Can’t Use ePRO and Other Industry Myths: An Interactive Debate
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5:00pm • #526 OD: ON DEMAND - Assessing the Adoption of Clinical Trial Results Summary Disclosure to Patients and the Public
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5:00pm • #532 OD: ON DEMAND - Setting a Strategic Foundation for Mutually Beneficial Collaborations Between Industry and Patient Organizations
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5:00pm • #552 OD: ON DEMAND - Regulatory Barriers to Entry for Biosimilars
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5:00pm • #529 OD: ON DEMAND - Impact Patient Centered Initiatives in Clinical Trial Design and Execution
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5:00pm • #534 OD: ON DEMAND - Bridging Bench to Bedside With Novel Biomarkers
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5:00pm • #547 OD: ON DEMAND - New Drugs Regulatory Program Modernization
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5:00pm • #563 OD: ON DEMAND - Best Practices for Randomization and Re-Randomization in Clinical Trials
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5:00pm • #531 OD: ON DEMAND - Global Commission Harnessing Cutting-Edge Technology to Accelerate Diagnosis of Rare Diseases in Children
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5:00pm • #543 OD: ON DEMAND - Opportunities and Challenges for ICH E6 (GCP) Renovation
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5:00pm • #568 OD: ON DEMAND - Gaslighting at Work: How to Recognize and Respond to this Unique Form of Harassment
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5:00pm • #556 OD: ON DEMAND - Demystifying Global Device Requirements: High Level Comparison of Current Expectations
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5:00pm • #530 OD: ON DEMAND - The DEEP Model: Long-Term Commitment to Partnering With Patients
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5:00pm • #559 OD: ON DEMAND - Replication of Randomized Controlled Trials Using Real World Data: What Does Good Look Like?
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5:00pm • #512 OD: ON DEMAND - Pediatric Clinical Trial Design and Ethical Considerations: Understanding Prospect of Direct Benefit and Risk
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5:00pm • #542 OD: ON DEMAND - Impact of Advanced Data Analytics Capabilities on Quality and Compliance Activities: Overview and Case Studies
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5:00pm • #537 OD: ON DEMAND - Combination Therapies of Investigational Agents
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5:00pm • #504 OD: ON DEMAND - What Does THAT Mean? Communicating Study Risks and Benefits in Patient-Friendly Language
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5:00pm • #565 OD: ON DEMAND - Considerations for Long-Term Outcomes Data Collection for Value-Based Payment Arrangements
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5:00pm • #540 OD: ON DEMAND - Recipe for Transformation to Higher-Performing Teams
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5:00pm • #515 OD: ON DEMAND - Artificial Intelligence: Use Cases from Real Trials
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5:00pm • #504.1 OD: ON DEMAND - The Opioid Epidemic: Top Ten Lessons in Regulatory Science
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5:00pm • #503 OD: ON DEMAND - MedDRA® Labeling Groupings for Enhanced Communication of Safety Concepts: Cinderella’s Glass Slipper?
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5:00pm • #508 OD: ON DEMAND - Optimizing Study Start Up Processes: Site Selection, Budgeting, and Contracting
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5:00pm • #506 OD: ON DEMAND - The Power of Real World Data and the Innovative Approaches for Usage
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5:00pm • #533 OD: ON DEMAND - Phase 1 Cell and Gene Therapy Research: Special Considerations for CMC, Regulatory Approvals, and Site Preparation
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5:00pm • #549 OD: ON DEMAND - Translating Frequently Collected Patient Experience Data into Meaningful Trial Endpoints
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5:00pm • #560 OD: ON DEMAND - Using Data Visualization to Drive Meaningful Insights
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5:00pm • #513 OD: ON DEMAND - Templates That Do More: How We Are Accelerating Drug Development via Structured Content Reuse
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5:00pm • #571 OD: CRO Leadership Awards
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5:00pm • #557 OD: ON DEMAND - N-Nitrosamines Contamination Case Lessons Learned
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5:00pm • #562 OD: ON DEMAND - Utilization of Bayesian Statistics in Clinical Trials
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5:00pm • #509 OD: ON DEMAND - Faster, Better, Cheaper: The Changing Role of Real World Data in Drug Development
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5:00pm • #519 OD: ON DEMAND - Applying the Concepts of Good Clinical Practice in Real World Evidence
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5:00pm • #514 OD: ON DEMAND - Single-Sponsor Master Protocol: Development and Regulatory Experience with a Complex Innovative Design (CID)
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5:00pm • #554 OD: ON DEMAND - Strengthening Food and Drug Regulatory Systems Abroad: Recommendations from the FDA-Commissioned NASEM Report
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5:00pm • #527 OD: ON DEMAND - Patient Preferences in the Medical Product Lifecycle: Evolving Uses, Stakeholder Considerations, and Applications
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5:00pm • #545 OD: ON DEMAND - Clinical Safety: Approaches to Assure Compliance in the Pharmacovigilance and GCP Interface
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5:00pm • #517 OD: ON DEMAND - Getting Real About Data Sharing for Drug Development and Drug Safety: What COVID-19 is Teaching us About the Possibilities and How to Move From Anomaly to Precedent
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5:00pm • #501 OD: ON DEMAND - Advancing Risk Management: What Can Evidence-Based Practices to Disseminate Healthcare Evidence into Practice Teach Us?
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5:00pm • #518 OD: ON DEMAND - Advancing Clinical Research Through Fast Healthcare Interoperability Resources: An Industry Perspective of Where We Are and Where To Go
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5:00pm • #561 OD: ON DEMAND - Hype or Hope: Quantifying the Risk of Patients with Complex Diseases
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5:00pm • #520 OD: ON DEMAND - Wearables
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5:00pm • #535 OD: ON DEMAND - Developing Products by the FDA Animal Rule: Working with FDA and Real World Challenges
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5:00pm • #546 OD: ON DEMAND - Quality Oversight of Pharmacovigilance Processes
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5:00pm • #570 OD: ON DEMAND - Networking for Everyone: Extrovert/Introvert/Centrovert
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5:00pm • #536 OD: ON DEMAND - Microbiome Therapies Beyond Fecal Microbiota Transplantation: Challenges and Opportunities
