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11A: Real-World Evidence: The Evolving Landscape of Regulators, Data, and Integrated Use 9:30am - 12:30pm
12P: Understanding the Bayesian Approach in Decision Making for Anyone Involved in Clinical Trial Design or Interpretation 1:00pm - 4:00pm
21A: Signal Management in Pharmacovigilance 9:30am - 12:30pm
22P: Global Labeling: The Basics of Core Datasheet 1:00pm - 4:00pm
31A: Introduction to Cell and Gene Therapies: Specific Regulatory, CMC, Non-clinical and Clinical Requirements and Considerations 9:00am - 12:30pm
32P: Talking Statistics: Interpreting Statistical Results for Non-Statisticians Involved with Clinical Trials 1:00pm - 4:00pm
Risk-Based Monitoring in Clinical Trials: A Four Year Analysis 10:45am - 11:45am
What’s in the Future for Global Advancements in Patient Engageme... 10:45am - 11:45am
New Alternative Methods-Only IND Application: Distant Dream or I... 10:45am - 11:45am
Diversity and Inclusion Implications for Global Regulatory 10:45am - 11:45am
Negotiating your Next Offer 10:45am - 11:45am
Inspired by Big-Tech and Humbled by Complexity of Clinical Resea... 10:45am - 11:45am
Artificial Intelligence: Delivering on the Promise 10:45am - 11:45am
E9(R1) Implementation: Practical Applications of Using Estimands... 10:45am - 11:45am
ICH E6 R3 Forum: Highlights of What's new and What Changed Regar... 10:45am - 11:45am
Sponsor-CRO Collaborations and the Impact of Decentralized Clini... 10:45am - 11:45am
Cell and Gene Therapies Pulse Check 10:45am - 11:45am
Applying Implementation Science Methods to Generate Evidence to... 10:45am - 11:45am
International Collaboration for Pharmaceutical Quality and Manuf... 1:30pm - 2:30pm
Combating Misinformation with Authoratative Medical Product Info... 1:30pm - 2:30pm
Enhancing the Quality of Safety Data Collection 1:30pm - 2:30pm
Can We Further Innovate Clinical Trial Designs? Lessons Learned... 1:30pm - 2:30pm
Consent is the Oil of Customer Engagement: How to Keep the Omnic... 1:30pm - 2:30pm
WHO Town Hall: The New Era of WHO Listed Authorities (WLAs), Rel... 1:30pm - 2:30pm
Do Surrogate Endpoints Expedite or Hinder Payer Coverage of Drug... 1:30pm - 2:30pm
Advances in Real-World Evidence: Randomized Clinical Trials Dupl... 1:30pm - 2:30pm
Novel Biomarkers and Surrogate Endpoints in a Rare Disease 1:30pm - 2:30pm
Building Trust: Data Privacy in Decentralized Clinical Trials 1:30pm - 2:30pm
Patient Involvement Optimizes Clinical Protocol Design: Real-Wor... 1:30pm - 2:30pm
Contemporary Challenges in Personalized Medicine and Companion D... 1:30pm - 2:30pm
Unleashing the Fearless Quality Professional 1:30pm - 2:30pm
Innovative Digital Health Technologies: Strategies for Successfu... 1:30pm - 2:30pm
Patient-Reported Outcome Measures to Support Oncology Clinical D... 1:30pm - 2:30pm
What's Next in Precision Medicine? Translational Strategies for... 4:15pm - 5:15pm
Creating your Career Plan 101: A Practical Workshop 4:15pm - 5:15pm
Regulatory Cooperation, Coordination, and Reliance in Times of C... 4:15pm - 5:15pm
Digital Endpoint Qualifications in Clinical Trials: Collaboratio... 4:15pm - 5:15pm
Utilizing Wearable Biosensors to Better Manage Patient Safety Du... 4:15pm - 5:15pm
The True Decentralization of Clinical Trials: Benefits and Drawb... 4:15pm - 5:15pm
Enabling the Use of Randomized Pragmatic Studies to Generate Hig... 4:15pm - 5:15pm
How to Assess and Implement Patient Preferences in Decision-Maki... 4:15pm - 5:15pm
The Promise of Vaccine Platforms to Advance Regulatory Science:... 4:15pm - 5:15pm
One Year On: How Quality Briefs are Transforming the Approach to... 4:15pm - 5:15pm
What Patients and Care Partners are Saying about Hybrid and Dece... 4:15pm - 5:15pm
Supporting Providers in Value-Based Contracts: Machine Learning... 4:15pm - 5:15pm
Emerging Therapies and Technologies and Leveraging Opportunities... 4:15pm - 5:15pm
Best Practices in Effective Gathering of Medical Information Ind... 4:15pm - 5:15pm
Challenges in Analytical Development of Cell and Gene Therapy Pr... 4:15pm - 5:15pm
Innovation Across Medical Affairs Throughout the Global Pandemic 8:30am - 9:30am
ICH M11 Clinical Electronic Structured Harmonized Protocol (CeSH... 8:30am - 9:30am
Ethical Considerations for Conducting Research During Times of D... 8:30am - 9:30am
Pediatrics and the Paradox of Progress: What’s New, What’s Next,... 8:30am - 9:30am
Innovating Patient Recruitment Through Pharmacy Channels 8:30am - 9:30am
Leveraging Analytics, Visualizations, and Decision Science to Dr... 8:30am - 9:30am
International Regulatory Convergence and Collaboration 8:30am - 9:30am
Office of Generic Drugs/Office of Pharmaceutical Quality Town Ha... 8:30am - 9:30am
The Case for Generating Synthetic Data as Real-World Data: Regul... 8:30am - 9:30am
Illuminating Risk Minimization Effectiveness Measurement 8:30am - 9:30am
A Regulatory Pharmaceutical Quality Knowledge Management System... 10:30am - 11:30am
Disrupting the Status Quo: Best Practices for Bringing Together... 10:30am - 11:30am
The Rare Disease Cures Accelerator-Data and Analytics Platform (... 10:30am - 11:30am
Medical Storytelling Inserted Into All Aspects of Medical Affair... 10:30am - 11:30am
Is Mark Cuban Really Solving the Drug Pricing Problem? 10:30am - 11:30am
IMPALA (IntercoMPany quALity Analytics) Industry Consortium: Qua... 10:30am - 11:30am
Good Recruitment Practice Under Regulation (EU) No 536/2014 10:30am - 11:30am
The Future of Regulatory Submissions: Opportunities and Challeng... 10:30am - 11:30am
Benefit-Risk Balance for Medicinal Products: CIOMS Working Group... 10:30am - 11:30am
ANVISA Townhall 10:30am - 11:30am
International Harmonization of Real-World Data/Real-World Eviden... 10:30am - 11:30am
Patient Experience Data in the Label: Closing the Loop 10:30am - 11:30am
The Full Picture: Innovative Software Tools for Data Insight Gen... 10:30am - 11:30am
Post-Pandemic Regulatory Innovation for Clinical Trials and Oppo... 10:30am - 11:30am
Getting Things Done in Drug Development Using Agile Practices 1:15pm - 2:15pm
Quality in the Real World: Diagnosing and Addressing Inaccuracie... 1:15pm - 2:15pm
Using Artificial Intelligence to Illuminate Predictive Relations... 1:15pm - 2:15pm
Meta-Collaboration to Improve Decentralized Trial Excellence: Up... 1:15pm - 2:15pm
Pharmacovigilance: Regulator's Perspectives on Quality Approache... 1:15pm - 2:15pm
Novel Methods for Signal Identification for Medicines and Medica... 1:15pm - 2:15pm
Implementing Digital Health Technologies in Clinical Trials: How... 1:15pm - 2:15pm
Demystifying the Common Legal Agreements, Key Terms, and Pitfall... 1:15pm - 2:15pm
Measuring Impact of Patient Engagement Across Research and Devel... 1:15pm - 2:15pm
Asia Town Hall 1:15pm - 2:15pm
Tech-Enabled Narratives: Technology Meets Process FTW (For the W... 1:15pm - 2:15pm
One Dossier and One Timeline for a Post Approval Change: The Sto... 1:15pm - 2:15pm
Global Regulatory Perspectives About Real-World Data: DARWIN EU®... 1:15pm - 2:15pm
The Inflation Reduction Act Price Setting: What are the Impacts... 1:15pm - 2:15pm
Hot off the Press: Site Challenges and Solutions in Workforce an... 1:15pm - 2:15pm
Quality Aspects of FY23-28 User Fee Agreements 4:00pm - 5:00pm
Patient-Preferences and Multistate Models to Enhance Patient-Foc... 4:00pm - 5:00pm
Smarter Approaches to Pharmacovigilance Challenges 4:00pm - 5:00pm
SMART-on-FHIR: Integrating Electronic Health Records as Real-Wor... 4:00pm - 5:00pm
Can Pragmatic Trials Simultaneously Meet the Needs of Regulators... 4:00pm - 5:00pm
Data Analytics for Quality Assurance: Shifting the Paradigm from... 4:00pm - 5:00pm
PMDA Town Hall 4:00pm - 5:00pm
The Many Faces of In-Trial Interviews: Navigating Operational an... 4:00pm - 5:00pm
Globally Accelerating the Drive to eLabeling for All 4:00pm - 5:00pm
Improving Patient Access with Real-World Evidence: A Framework f... 4:00pm - 5:00pm
IDMP and Data Harmonization Methods: How Your Company will be Im... 4:00pm - 5:00pm
An Assessment of the Challenges Associated with Cell and Gene Th... 4:00pm - 5:00pm
Negotiating your Way Through the Vigilance Agreement Maze: Is Th... 4:00pm - 5:00pm
Generating Patient Insights to Inform Health Policy Issues: Poli... 4:00pm - 5:00pm
The Rapidly Changing Landscape of Data Collection and its Implic... 8:30am - 9:30am
Returning Individual Participant Data: A Cultural and Operationa... 8:30am - 9:30am
Using Real-World Data to Evaluate Safety Signals 8:30am - 9:30am
Writing Summary Documents for Rare Disease Submissions: Unique C... 8:30am - 9:30am
Strategies for Benefit-Risk Analysis in Regulatory Submissions 8:30am - 9:30am
Real-World Data Quality: Components and Considerations of Data S... 8:30am - 9:30am
Strategies to Make the Right Virtual Connection: Play and Learn 8:30am - 9:30am
Advancing PV in Africa 8:30am - 9:30am
Leveraging Project Management Skills for Significant Drug Develo... 8:30am - 9:30am
Best Practices for Managing Rare Disease Trials in Latin America... 10:30am - 11:30am
PI 1572 Responsibility and Oversight in Decentralized Clinical T... 10:30am - 11:30am
Health Canada Town Hall 10:30am - 11:30am
Opportunities to Improve Risk Minimization Outcomes with Behavio... 10:30am - 11:30am
Leveraging Data Scientists and Data Managers with Evolving Proto... 10:30am - 11:30am
Registries Aren’t Always the Answer: Novel Designs for Executing... 10:30am - 11:30am
What Can ICH Bring to the Future of Model-Informed Drug Developm... 10:30am - 11:30am
Combining Qualitative and Quantitative Research to Generate With... 10:30am - 11:30am
How Real-World Data from Wearable Biosensors and Artifical Intel... 10:30am - 11:30am
Operationalizing Real-World Data: Methods, Acceptance, and Futur... 10:30am - 11:30am
Reliance in Action: How to Ensure Product Sameness When Using Gl... 10:30am - 11:30am
Is the Hype Real? Real-Life User Experience of Medical Writing A... 10:30am - 11:30am
Dose Optimization in Oncology: How Do we Tackle the Tricky Topic... 10:30am - 11:30am
Patient-Focused Drug Development in Rare Disease Endpoint Select... 10:30am - 11:30am
25-Years After FDAMA: How is FDA Applying the Confirmatory Evide... 10:30am - 11:30am
The Future of Biosimilar and Interchangeable Biologics: Global D... 1:15pm - 2:15pm
Real-World Data: Maximizing Value and Quality Through End-to-End... 1:15pm - 2:15pm
Industry and Regulators’ Experience with the Implementation and... 1:15pm - 2:15pm
Evolving Global Landscape for Addressing Drug Shortages: Innovat... 1:15pm - 2:15pm
Capturing the Patient Voice Using Longitudinal Qualitative Resea... 1:15pm - 2:15pm
Performance, Interrupted: Examining Diversity, Equity, and Inclu... 1:15pm - 2:15pm
Operationalizing FDA Medical Queries 1:15pm - 2:15pm
FDA Rare Disease Town Hall 1:15pm - 2:15pm
Regulatory Insights into Decentralized Clinical Trials 1:15pm - 2:15pm
Fostering Cross-Functional Team Success with Project Management... 1:15pm - 2:15pm
Opportunities and Issues with Existing Analytical Technologies f... 1:15pm - 2:15pm
Today’s Episode of Clinical Research Talk Explores Clinical Adju... 1:15pm - 2:15pm
Managing BYOD and Wearables in Clinical Trials: Sustainable Data... 1:15pm - 2:15pm
Estimands and Designing of the Clinical Trial and Protocol Struc... 1:15pm - 2:15pm
Patient and Quality Impacts of Restrictions on the Use of Titani... 4:00pm - 5:00pm
Critically Thinking Organization: An Action-Oriented Workshop fo... 4:00pm - 5:00pm
Assessing Safety in Rare Disease Gene Therapy 4:00pm - 5:00pm
Leading Cross-Functional Teams Through Mergers, Divestments, and... 4:00pm - 5:00pm
From 1000's of Tables to Summarizing Clinical Trials Graphically 4:00pm - 5:00pm
Quality by Design for Real-World Evidence Studies 4:00pm - 5:00pm
Regulatory Reliance: Addressing Gaps to Harmonize and Enhance Up... 4:00pm - 5:00pm
Patient-Generated Health Data and Real-World Evidence: How Can T... 4:00pm - 5:00pm
Modernizing the Clinical Trials Environment in Europe: ACT EU an... 4:00pm - 5:00pm
Mobilizing Cooperation with the African Medicines Agency 4:00pm - 5:00pm
Crafting the Message: Driving Drug Development Through Compellin... 8:30am - 9:30am
FDA Sponsor Interaction: Best Practices and New PDUFA Formal Mee... 8:30am - 9:30am
Effective Use of Intelligent Automation in Clinical and Regulato... 8:30am - 9:30am
Implementing the Program Safety Analysis Plan and Enhancing Ongo... 8:30am - 9:30am
International Medical Device Regulators Forum (IMDRF) and Techno... 8:30am - 9:30am
The Value of Patient-Centric Communication Strategies 8:30am - 9:30am
Demystifying Statistical Concepts for ANYONE Involved with Clini... 8:30am - 9:30am
A Global Sponsor Perspective on Implementation of the New EU Cli... 8:30am - 9:30am
The Other Side of the Table: Drug Development Professionals Shar... 9:45am - 10:45am
Reporting of Pre- and Postmarket Safety Reports to FDA Adverse E... 9:45am - 10:45am
Statistical Applications of Machine Learning (ML) and Artificial... 9:45am - 10:45am
Process Automation and Artificial Intelligence in the Field: Pra... 9:45am - 10:45am
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