DIA 2020 Virtual Global Annual Meeting has ended

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DIA 2020 Virtual Global Annual Meeting

8:00am EDT

SC35: #35: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development TBD

9:00am EDT

SC19: #19: Core Labeling TBD SC22: #22: Data Visualization in the Life Sciences TBD SC24: #24: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model TBD SC21: #21: Real World Evidence: The Evolving Landscape of Regulators, Data and Integrated Use TBD SC25: #25: Regulatory Requirements for IND/NDA Procedures in China TBD SC26: #26: “Has it Happened Already?” Questions of Precedent from which Regulatory Intelligence Can Save You TBD #e-Posters: Professional and Student e-Posters Gallery TBD

11:00am EDT

#0000 OR1: DIA 2020 Virtual Meeting Orientation TBD

12:30pm EDT

#0001 L: Student and Emerging Professionals Forum TBD

1:00pm EDT

#0000 OR2: DIA 2020 Virtual Meeting Orientation TBD

1:30pm EDT

#0002 L: Student and Young Professionals Resume Workshop TBD SC28: #28: Leadership: How to Organize and Lead People in a Work Group TBD SC33: #33: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development Lifecycle TBD SC34: #34: Preparing for a US FDA Advisory Committee Meeting TBD

2:30pm EDT

#0003 SL: The Five Steps to Establish Yourself as an Influencer and Improve Your Professional Communications TBD

4:00pm EDT

#0004 SL: Student Self-Awareness Workshop TBD

8:00am EDT

#100 SL: DIA Global Annual Meeting – Opening DIAmond and Plenary Session TBD

10:15am EDT

#101 SL-CH: Challenges in Advanced Therapy Development: A New Community TBD #102 SL-IT: Advanced Clinical Innovation Theater: Future Forward Trends for Overcoming the Talent Shortage in Clinical Research while Diminishing Risk TBD #103 SL-IT: Veeva Innovation Theater: Annual Industry Report - Trends, Insights, and Strategies to Modernize Clinical Operations TBD #104 SL-IT: ArisGlobal Innovation Theater: Leveraging Automation in PV TBD

11:00am EDT

#105 SL: To Shape the Future of Patient Labeling Across Regions TBD #106 SL: Clinical Trials in a Digital Age: A Modern Approach to an Outdated Model TBD #107 L: Patients First! How FDA is Making Patients a Priority TBD #108 SL: Leveraging Clinical Pharmacology to Transform Real World Data into Real World Evidence for Special Patient Populations TBD #109 L: International Convergence on Regulatory Review and HTA: Getting the “Universal Evidence” We Need for Decisions on Innovation TBD #110 L: Outcomes as a Pathway to Value and Pharma, Payer, Provider Collaboration TBD

12:00pm EDT

#601 NL: Networking Lounge: Real World Evidence TBD #602 NL: Networking Lounge: COVID-19 TBD #603 NL: Networking Lounge: Patient Focused TBD #604 NL: Networking Lounge: Emerging Professionals and Students TBD #605 NL: Networking Lounge: Advanced Therapies TBD #607 NL: Networking Lounge: Digital Technology and Artifical Intelligence TBD #608 NL: Networking Lounge: Data Science TBD #608.1 NL: Networking Lounge: Diversity, Disparities, and Inclusiveness TBD

12:30pm EDT

#111 SL-CH: Collecting Meaningful Patient Experience Data TBD #113 SL-IT: Google Innovation Theater: Enabling Insights and Collaboration Across the Lifesciences Enterprise with Google Cloud and Accenture TBD #115 SL-IT: IQVIA Innovation Theater: COVID-19 Disruption Provides a Pivotal Opportunity to Accelerate Patient Engagement Innovation TBD #116 SL-IT: Parexel Innovation Theater: The Future is Now: The Rise and Rise of Decentralized Clinical Trials During the COVID Pandemic and Beyond TBD #112 L-RT: Round Table Discussion: Patients First! How FDA is Making Patients a Priority TBD

1:00pm EDT

#117 SL-IT: Syneos Health Innovation Theater: Patient Engagement: Driving Better Care and Outcomes TBD #118 SL-IT: WCG Innovation Theater: A Tale of Two Eras: Interpreting Clinical Operations Data Pre- and Post- COVID-19 TBD #118.1 SL-IT: UBC Innovation Theater: Unlocking the Evidence-Generating Potential of the EMR TBD

1:30pm EDT

#119 L: How Do You Oversee and Manage New Centralized/Remote/Site Monitoring Models? What Should you Measure to Gain Insights? TBD #120 L: The Changing Role of the Data Professional TBD #121 SL: Non-Profit Organizations Role in Accelerating Preclinical Compound Testing to Fuel the Rare Disease Clinical Pipeline TBD #122 L: ICH 30th Anniversary Series: Harmonizing Global Requirements for Clinical Trials TBD #123 L: Is Your App a Drug, a Device, or Something Else Entirely? TBD #124 SL: Gene Therapy Manufacturing: How Can Innovation Help Overcome This Anticipated Hurdle? TBD

2:30pm EDT

#125 SL-IT: Covance Innovation Theater: Driving Patient-Centric Trials: Moving Beyond the Hype TBD #126 SL-IT: SAS Innovation Theater: The Role of Augmented Clinical Trials in the Response to COVID-19 and Beyond TBD #127 SL-IT: IQVIA Innovation Theater 2: Digital Patient Orchestration, An Examination of the Patient Journey TBD

3:00pm EDT

#128 SL-IT: Appian Innovation Theater - Bayer: Shaping the Future to Meet Our Needs – A Digital Transformation TBD

3:30pm EDT

#129 SL: The Rare Disease Clinical Outcome Assessment Consortium: Aiming to Fulfill Unmet Drug Development Endpoint Measurement Needs TBD #130 L: Virtual Clinical Trials TBD #131 L: Engaging Patients to Support the Modernization of ClinicalTrials.gov TBD #132 SL: Benchmarking and Identifying Opportunities to Improve Intentional Dose Non-Adherence in Clinical Trials TBD #133 L: FDA’s Considerations on Benefit-Risk Assessment for Human Drug Review TBD #134 L: Should a COVID-19 Vaccination be Legally Mandated and Can HTA Inform That Decision? TBD

8:00am EDT

#201 L: Patient-Centricity: How do We Measure Progress in Involving Patients in Drug Development and Drug Safety? TBD #202 L: Novel Approaches to Study Prevalent Chronic Diseases as Alternatives to Large-Scale Clinical Trials TBD #203 L: ICH 30th Anniversary Series: The Role of Multidisciplinary Topics TBD #204 L: Implementing Quality by Design for Clinical Trials: New Tools, Case Studies, and Multi-Stakeholder Discussion TBD #205 SL: Using Artificial Intelligence to Inform Regulatory and Development Strategies TBD #206 L: Regulatory Agility During the COVID-19 Pandemic TBD

9:00am EDT

#208.1 SL-IT: IBM Innovation Theater: New Ways to Apply Decentralized Trials During Covid-19 TBD #208.2 SL-IT: Covance Innovation Theater: Managing Complexity: The COVID-19 Road To Recovery and Restoration TBD

9:30am EDT

#209 L: Data Driven Monitoring Enabled Through Analytics and Quality Risk Management TBD #210 SL: Clinical Electronic Structured Harmonized Protocol (CeSHarP): ICH M11 - Status Update TBD #211 L: Balancing Clinical Trial Disclosure and Transparency With Global Data Protection Regulations TBD #212 L: Qualitative, Quantitative, and Mixed Method Approaches to Capture the Patient Experience TBD #213 L: Project Management in Times of Crisis TBD #214 L: GCP Quality and Compliance: The Regulators’ Perspective TBD #215 L: ACTIV: A Public-Private Partnership to Speed COVID-19 Therapies and Vaccines TBD

10:45am EDT

#217 SL-IT: ArisGlobal Innovation Theater: The Evolving Role of CTMS in Risk Management TBD #218 SL-IT: Veeva Innovation Theater: The Next Big Step Toward a Collaborative Clinical Ecosystem TBD #219 SL-IT: Google Innovation Theater: Next Generation Biomedical and Clinical Research Platform with Google Cloud and Deloitte TBD #216 L-RT: Round Table Discussion: Patient-Centricity: How Do We Measure Progress in Involving Patients in Drug Development and Drug Safety? TBD

11:30am EDT

#220 L: Disruptive Transformation in Safety Organizations TBD #221 L: Non-Traditional Clinical Trials Require a Non-Traditional Workforce TBD #222 L: Patient-Centricity: How Do We Talk to and Listen to Patients? TBD #223 L: Next Generation Analytics: Harnessing the Power of Nonclinical SEND Datasets to Improve Success in Early Clinical Development TBD #224 SL: Sponsor and Regulator Challenges, Risks, and Mitigation Strategies for Ensuring Third-Party Oversight of Vendors: Is Your Study Data at Risk? TBD #225 L: Accelerated Approval and Emerging Surrogate Endpoints TBD

12:30pm EDT

#609 NL: Networking Lounge: Real World Evidence TBD #610 NL: Networking Lounge: COVID-19 TBD #611 NL: Networking Lounge: Patient Focused TBD #612 NL: Networking Lounge: Emerging Professionals and Students TBD #613 NL: Networking Lounge: Digital Technology and Artifical Intelligence TBD #614 NL: Networking Lounge: Advanced Therapies TBD #615 NL: Networking Lounge: Data Science TBD #616 NL: Networking Lounge: Diversity, Disparities, and Inclusiveness TBD

12:45pm EDT

#226 SL-IT: Intersystems Innovation Theater: Investing in Real-Time, Real World Data to Accelerate Clinical Trials and Enhance Market Access TBD #228 SL-IT: Bioclinica Innovation Theater: Rescuing Clinical Adjudication Studies - Special Considerations When Transitioning From an Under-Performing Adjudication Provider TBD

1:15pm EDT

#229 L-RT: Round Table Discussion: RIM Working Group Update TBD

1:30pm EDT

#230 SL-CH: Staying Connected in a Virtual World: Communications Stakeholder Engagement That Drive Results TBD

1:40pm EDT

#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... TBD

2:00pm EDT

#233 L: Practical Considerations for Robust Evaluation of Risk Minimization Programs: Regulatory, Industry, and Service Provider Insights TBD #234 SL: Practical Solutions for Designing and Conducting a Digital Health Trial TBD #235 SL: Examining Diversity in Clinical Trials TBD #236 L: FDA Data Standards Update TBD #237 L: Patient Voice and Its Role In Bringing Meaningfulness into Selection of Clinical Outcome Measures TBD #238 SL: Utilizing Cloud-Based Platforms in Regulatory Contexts TBD #239 L: The FDA Complex Innovative Trial Design Pilot Program: Case Examples TBD

3:15pm EDT

#241 SL-CH: A Risk-Based Approach to Implement Audit Trail Review and Inspection Readiness Plans in a Data Integrity Conscious World TBD #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? TBD #244 SL-IT: Veeva Innovation Theater: It's Time to Rethink Your EDC TBD #245 SL-IT: Parexel and Microsoft Innovation Theater: #KeepingPatientsFirst - An Integrated Research Platform for COVID-19 TBD #242 L-RT: Round Table Discussion: Examining Diversity in Clinical Trials TBD

4:00pm EDT

#246 SL: FDA Pre-Market Safety Assessment Program TBD #247 SL: Engaging Caregivers in Research and Medical Product Development TBD #248 L: Incorporating the Patient Perspective in a Drug Development Program TBD #249 L: Dynamic Multi-Disciplinary Collaboration for Aggregate Product Safety Assessment and Benefit-Risk Planning TBD #250 L: Projecting a Voice of Confidence in a World of Uncertainty TBD

8:00am EDT

#301 SL: Combining Multiple Real World Data Sources to Maximize Value TBD #302 L: Seamlessly Evolving Global Clinical Trial Liaison Field Medical Resources to Classic MSLs from Phase 3 to Launch TBD #303 SL: Detection of Anomalies in eCOA Data and Metadata for More Pre-Emptive, Evidence-Based Risk Management TBD #304 L: Strategic Directions from Global Medicines Regulators: The ICMRA Statement on Combatting Antimicrobial Resistance TBD #304.1 L: ICH 30th Anniversary: Achievements and Future Prospects TBD #306 L: Defining the Treatment Effect of Interest in Regulatory Submissions: Estimands and ICH E9R1 Final Guidance TBD

9:00am EDT

#307 SL-IT: Salesforce Innovation Theater: Recruit and Engage Trial Participants with a Connected Platform TBD

9:30am EDT

#309 L: If You Build it, Will They Come? What’s Really Needed to Transform Information Flow in Clinical Development TBD #310 L: Global Rare Disease Town Hall TBD #311 L: ICH 30th Anniversary Series: Advancing Pharmaceutical Safety TBD #312 L: Pediatric Development: Can Increasing Collaboration Lead to Fewer Unnecessary Trials? TBD

10:45am EDT

#313 SL-IT: UBC Innovation Theater: What You Need to Know About Assembling an Integrated Registry TBD #314 SL-IT: IQVIA Innovation Theater: Modernizing Regulatory Evidence with Real World Studies TBD #315 SL-IT: Microsoft Innovation Theater: Journey to the Fully Digital Study Starts with Standards TBD

11:30am EDT

#316 SL: Report of CIOMS DILI Working Group TBD #317 L: Evolving Trials for the Digital Age TBD #318 L: Data Strategy and Privacy Compliance in the Age of Digital Health: GDPR, HIPAA, and CCPA Implications TBD #319 L: Leading Through Complexity: Opportunities, Pitfalls, and Best Practices for Managing Successful Partnerships TBD #320 L: Advanced Therapy Medicinal Products: Facilitating Individualized Gene Therapies and Cell-Based Therapeutics TBD #321 L: Recommendations for a Strategic Response to the COVID-19 Pandemic TBD

12:30pm EDT

#617 NL: Networking Lounge: Emerging Professionals and Students TBD #618 NL: Networking Lounge: Real World Evidence TBD #619 NL: Networking Lounge: COVID-19 TBD #620 NL: Networking Lounge: Patient Focused TBD #621 NL: Networking Lounge: Advanced Therapies TBD #622 NL: Networking Lounge: Digital Technology and Artifical Intelligence TBD #623 NL: Networking Lounge: Data Science TBD #624 NL: Networking Lounge: Diversity, Disparities, and Inclusiveness TBD

12:45pm EDT

#323 SL-IT: IQVIA Innovation Theater: Driving Quality Through Innovative Digital Trial Approaches in a Pandemic Era TBD #324 SL-IT: JMP Innovation Theater: Adverse Events in Clinical Trials: When Doctors Require a Statistical Perspective TBD #322 L-RT: Round Table Discussion: Data Strategy and Privacy Compliance in the Age of Digital Health: GDPR, HIPAA, and CCPA Implications TBD

1:15pm EDT

#325 SL-IT: Covance Innovation Theater: Tailoring Your Journey Map Using a Data Driven Approach to Accelerate Patient Recruitment and Improve Patient Retention TBD

1:30pm EDT

#329 SL-CH: The New DIA Statistics and Data Science Community TBD

2:00pm EDT

#330 L: Application and Validation of Intelligent Automation Technology in PV: Exploring Opportunities within the Individual ICSR Process TBD #331 L: Globalization of Medical Information TBD #332 SL: Optimizing Communication with Patients to Support Meaningful Feedback into the Research Process TBD #333 SL: Driving Quality Through Innovative Approaches TBD #334 L: Best Practices for Virtual Meetings with FDA! TBD

3:15pm EDT

#335 SL-CH: Role of Medical Communications Experts in Building Accelerated Regulatory Dossiers and Securing First-Attempt Approvals TBD

4:00pm EDT

#338 L: Immunogenicity of Biologics: Clinical Consequences TBD #339 SL: The Development of Novel Digital Endpoints TBD #340 SL: Approaches for Cross-Functional Teams to Enhancing Quality of Decision-Making During the Development and Review of Medicines TBD #341 L: Using Data Monitoring Strategies in Detection of Data Anomalies and Trial Misconduct TBD #342 L: Drug Pricing in the United States: How and Why is it Different Than in the Rest of the World TBD #343 L: Mindfulness: Beyond Meditation TBD

8:00am EDT

#401 L: Digital Risk Minimization: How Can We Advance Adoption? TBD #402 L: FDA Perspectives on Modernization of Clinical Trials: Real World Evidence, Decentralized Clinical Trials, and Digital Health Technologies TBD #403 L: Best Practices in Developing Medical Information Responses TBD #404 L: Incorporating Patient Input into Medical Product Development and the US Food and Drug Administration’s Decision-Making TBD #406 SL: FDA-PAHO: Landscape Report of Regulatory Situation in the Americas TBD #405 L: Catalyzing the Integration of Digital Technologies in Healthcare Solutions TBD #410 SL: Statistical Considerations for Using External Controls in Clinical Trials TBD

9:30am EDT

#411 L: Qualification and Oversight in Decentralized Trials: Practical Considerations for Clinical Operations and Quality Oversight TBD #412 L: Telling Health Stories for Drug Development TBD #413 L: Orphan Drug Development in Personalized Medicine TBD #414 SL: ICH 30th Anniversary Series: International Harmonization for Pharmaceutical Quality TBD #415 SL: Opportunities and Challenges for Real World Data and Real World Evidence: Dive Into the Details TBD #416 L: Trust: What Makes It: What Breaks It TBD

10:30am EDT

#417 SL-CH: Information Overload: Best Practices to Manage Information and Remember Where the Information Is! TBD

11:30am EDT

#421 L: Quantitative Benefit-Risk Assessment: What Methods are Being Used? How Far has Industry Come? TBD #422 L: How the FDA’s MyStudies Platform is Accelerating the Use of Digital Technology in Clinical Research and Clinical Trials TBD #423 L: Reusing What You Wrote the First Time: Deja Vu All Over Again TBD #424 L: Keep Calm and Carry On: Mindfulness to Increase Work Productivity TBD

2:00pm EDT

#431 L: FDA Town Hall TBD

5:00pm EDT

#501 OD: ON DEMAND - Advancing Risk Management: What Can Evidence-Based Practices to Disseminate Healthcare Evidence into Practice Teach Us? TBD #502 OD: ON DEMAND - Unblinding The New Face of the Local Safety Officer TBD #503 OD: ON DEMAND - MedDRA® Labeling Groupings for Enhanced Communication of Safety Concepts: Cinderella’s Glass Slipper? TBD #504 OD: ON DEMAND - What Does THAT Mean? Communicating Study Risks and Benefits in Patient-Friendly Language TBD #504.1 OD: ON DEMAND - The Opioid Epidemic: Top Ten Lessons in Regulatory Science TBD #505 OD: ON DEMAND - Older People Can’t Use ePRO and Other Industry Myths: An Interactive Debate TBD #506 OD: ON DEMAND - The Power of Real World Data and the Innovative Approaches for Usage TBD #507 OD: ON DEMAND - Managing Global Clinical Trials in Emerging Regions: Latin America TBD #508 OD: ON DEMAND - Optimizing Study Start Up Processes: Site Selection, Budgeting, and Contracting TBD #509 OD: ON DEMAND - Faster, Better, Cheaper: The Changing Role of Real World Data in Drug Development TBD #510 OD: ON DEMAND - Journey of TMF Reference Model in Driving Inspection Readiness: The Decade's Impact, the Evolution to Come TBD #511 OD: ON DEMAND - Design and Implementation of Multiregional Clinical Trials (MRCT) Using ICH E17 Guidelines TBD #512 OD: ON DEMAND - Pediatric Clinical Trial Design and Ethical Considerations: Understanding Prospect of Direct Benefit and Risk TBD #513 OD: ON DEMAND - Templates That Do More: How We Are Accelerating Drug Development via Structured Content Reuse TBD #514 OD: ON DEMAND - Single-Sponsor Master Protocol: Development and Regulatory Experience with a Complex Innovative Design (CID) TBD #515 OD: ON DEMAND - Artificial Intelligence: Use Cases from Real Trials TBD #516 OD: ON DEMAND - Deploying Machine Learning in Data Management TBD #518 OD: ON DEMAND - Advancing Clinical Research Through Fast Healthcare Interoperability Resources: An Industry Perspective of Where We Are and Where To Go TBD #519 OD: ON DEMAND - Applying the Concepts of Good Clinical Practice in Real World Evidence TBD #520 OD: ON DEMAND - Wearables TBD #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 TBD #521 OD: ON DEMAND - Data Related International Policy and Strategy: EVDAS, E2B (R3), GDPR TBD #522 OD: ON DEMAND - Online Medical Information Resources and Channels TBD #524 OD: ON DEMAND - Storyboarding for Key Message Alignment in Marketing Applications TBD #526 OD: ON DEMAND - Assessing the Adoption of Clinical Trial Results Summary Disclosure to Patients and the Public TBD #530 OD: ON DEMAND - The DEEP Model: Long-Term Commitment to Partnering With Patients TBD #531 OD: ON DEMAND - Global Commission Harnessing Cutting-Edge Technology to Accelerate Diagnosis of Rare Diseases in Children TBD #532 OD: ON DEMAND - Setting a Strategic Foundation for Mutually Beneficial Collaborations Between Industry and Patient Organizations TBD #527 OD: ON DEMAND - Patient Preferences in the Medical Product Lifecycle: Evolving Uses, Stakeholder Considerations, and Applications TBD #529 OD: ON DEMAND - Impact Patient Centered Initiatives in Clinical Trial Design and Execution TBD #528 OD: ON DEMAND - Communicate and Co-Create with Patients Across the Medicines Development Lifecycle: Principles and Best Practices TBD #533 OD: ON DEMAND - Phase 1 Cell and Gene Therapy Research: Special Considerations for CMC, Regulatory Approvals, and Site Preparation TBD #534 OD: ON DEMAND - Bridging Bench to Bedside With Novel Biomarkers TBD #535 OD: ON DEMAND - Developing Products by the FDA Animal Rule: Working with FDA and Real World Challenges TBD #536 OD: ON DEMAND - Microbiome Therapies Beyond Fecal Microbiota Transplantation: Challenges and Opportunities TBD #537 OD: ON DEMAND - Combination Therapies of Investigational Agents TBD #538 OD: ON DEMAND - Project Management Playbook to Effective Stakeholder Management TBD #539 OD: ON DEMAND - Revolutionizing Project Management Through Building Your Culture and Emotional Intelligence TBD #540 OD: ON DEMAND - Recipe for Transformation to Higher-Performing Teams TBD #542 OD: ON DEMAND - Impact of Advanced Data Analytics Capabilities on Quality and Compliance Activities: Overview and Case Studies TBD #543 OD: ON DEMAND - Opportunities and Challenges for ICH E6 (GCP) Renovation TBD #544 OD: ON DEMAND - Pharmacovigilance Inspections: Leveraging Inspection Intelligence as a Driver of Quality in Your Organization TBD #545 OD: ON DEMAND - Clinical Safety: Approaches to Assure Compliance in the Pharmacovigilance and GCP Interface TBD #546 OD: ON DEMAND - Quality Oversight of Pharmacovigilance Processes TBD #541 OD: ON DEMAND - Electronic Informed Consent: Global Perspectives TBD #547 OD: ON DEMAND - New Drugs Regulatory Program Modernization TBD #550 OD: ON DEMAND - PMDA Town Hall: The Path of a New Chief Executive Since His Appointment TBD #551 OD: ON DEMAND - Advancing Clinical Trial Innovation Through Model-Informed Drug Development TBD #552 OD: ON DEMAND - Regulatory Barriers to Entry for Biosimilars TBD #553 OD: ON DEMAND - What Makes Real World Data Trustworthy: A Focus on Design and Data TBD #554 OD: ON DEMAND - Strengthening Food and Drug Regulatory Systems Abroad: Recommendations from the FDA-Commissioned NASEM Report TBD #555 OD: ON DEMAND - Updates of Drug Evaluation and Inspection in China TBD #549 OD: ON DEMAND - Translating Frequently Collected Patient Experience Data into Meaningful Trial Endpoints TBD #556 OD: ON DEMAND - Demystifying Global Device Requirements: High Level Comparison of Current Expectations TBD #557 OD: ON DEMAND - N-Nitrosamines Contamination Case Lessons Learned TBD #558 OD: ON DEMAND - Quality Considerations for Complex Drugs TBD #559 OD: ON DEMAND - Replication of Randomized Controlled Trials Using Real World Data: What Does Good Look Like? TBD #560 OD: ON DEMAND - Using Data Visualization to Drive Meaningful Insights TBD #561 OD: ON DEMAND - Hype or Hope: Quantifying the Risk of Patients with Complex Diseases TBD #562 OD: ON DEMAND - Utilization of Bayesian Statistics in Clinical Trials TBD #563 OD: ON DEMAND - Best Practices for Randomization and Re-Randomization in Clinical Trials TBD #564 OD: On DEMAND - Communicating Value to Payers Pre-Approval in the US TBD #565 OD: ON DEMAND - Considerations for Long-Term Outcomes Data Collection for Value-Based Payment Arrangements TBD #566 OD: ON DEMAND - Subscription Models to Incentive Antimicrobial Innovation TBD #567 OD: ON DEMAND - Real World Use of Real World Evidence TBD #568 OD: ON DEMAND - Gaslighting at Work: How to Recognize and Respond to this Unique Form of Harassment TBD #570 OD: ON DEMAND - Networking for Everyone: Extrovert/Introvert/Centrovert TBD #571 OD: CRO Leadership Awards TBD