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Venue: TBD [clear filter]
Monday, June 12
 

9:30am CDT

11A: Real-World Evidence: The Evolving Landscape of Regulators, Data, and Integrated Use TBD

1:00pm CDT

12P: Understanding the Bayesian Approach in Decision Making for Anyone Involved in Clinical Trial Design or Interpretation TBD
 
Tuesday, June 13
 

9:30am CDT

21A: Signal Management in Pharmacovigilance TBD

1:00pm CDT

22P: Global Labeling: The Basics of Core Datasheet TBD
 
Wednesday, June 14
 

9:00am CDT

31A: Introduction to Cell and Gene Therapies: Specific Regulatory, CMC, Non-clinical and Clinical Requirements and Considerations TBD

1:00pm CDT

32P: Talking Statistics: Interpreting Statistical Results for Non-Statisticians Involved with Clinical Trials TBD
 
Monday, June 26
 

10:45am CDT

Artificial Intelligence: Delivering on the Promise TBD Risk-Based Monitoring in Clinical Trials: A Four Year Analysis TBD Sponsor-CRO Collaborations and the Impact of Decentralized Clinical Trials TBD Inspired by Big-Tech and Humbled by Complexity of Clinical Research: Clinical Trial Digital Transformation TBD What’s in the Future for Global Advancements in Patient Engagement and Patient-Focused Medical Product Development? TBD New Alternative Methods-Only IND Application: Distant Dream or Immediate Possibility? TBD ICH E6 R3 Forum: Highlights of What's new and What Changed Regarding Sponsor Responsibilities TBD Cell and Gene Therapies Pulse Check TBD Diversity and Inclusion Implications for Global Regulatory TBD E9(R1) Implementation: Practical Applications of Using Estimands in Protocols, SAPs, Data Standards in Clinical Trials and NDA/BLA Submissions to FDA TBD Applying Implementation Science Methods to Generate Evidence to Improve Access to New Therapeutics: What has Been Learned? TBD Negotiating your Next Offer TBD

1:30pm CDT

Enhancing the Quality of Safety Data Collection TBD Can We Further Innovate Clinical Trial Designs? Lessons Learned and Future Opportunities TBD Patient-Reported Outcome Measures to Support Oncology Clinical Development and Labeling: Responding to FDA’s Draft Guidance TBD Building Trust: Data Privacy in Decentralized Clinical Trials TBD Innovative Digital Health Technologies: Strategies for Successful Integrations, Quality, and Compliance TBD Consent is the Oil of Customer Engagement: How to Keep the Omnichannel Engine Running TBD Patient Involvement Optimizes Clinical Protocol Design: Real-World Experiences and Insights TBD Contemporary Challenges in Personalized Medicine and Companion Diagnostics TBD Unleashing the Fearless Quality Professional TBD Combating Misinformation with Authoratative Medical Product Information TBD Novel Biomarkers and Surrogate Endpoints in a Rare Disease TBD WHO Town Hall: The New Era of WHO Listed Authorities (WLAs), Reliance in Action, and Country and Regional Focus for Regulatory Systems Strengthening TBD International Collaboration for Pharmaceutical Quality and Manufacturing Agility TBD Advances in Real-World Evidence: Randomized Clinical Trials Duplicate, Publication Scandal, and China’s Real-World Evidence Heaven TBD Do Surrogate Endpoints Expedite or Hinder Payer Coverage of Drugs? TBD

4:15pm CDT

Utilizing Wearable Biosensors to Better Manage Patient Safety During Immuno-Oncology Studies TBD Enabling the Use of Randomized Pragmatic Studies to Generate High Quality Real-World Evidence for Regulatory Decisions TBD What Patients and Care Partners are Saying about Hybrid and Decentralized Trials TBD Digital Endpoint Qualifications in Clinical Trials: Collaborations and Applications TBD The True Decentralization of Clinical Trials: Benefits and Drawbacks of Blockchain Technology TBD Best Practices in Effective Gathering of Medical Information Industry Insights TBD How to Assess and Implement Patient Preferences in Decision-Making Along the Medical Product Life Cycle? TBD What's Next in Precision Medicine? Translational Strategies for Dose Optimization in the Age of Project Optimus TBD One Year On: How Quality Briefs are Transforming the Approach to Quality and Driving Innovation to Serve Patients TBD Emerging Therapies and Technologies and Leveraging Opportunities for Engaging with Medicine Regulators to Support Innovation TBD Regulatory Cooperation, Coordination, and Reliance in Times of Crisis: The ICMRA Role TBD The Promise of Vaccine Platforms to Advance Regulatory Science: Where are we Now, Where are we Going, and How do we get There? TBD Challenges in Analytical Development of Cell and Gene Therapy Products, Regulatory Perspectives, and Convergence TBD Supporting Providers in Value-Based Contracts: Machine Learning and Recursive Neural Networks for Outcomes and Treatment Journey Optimization TBD Creating your Career Plan 101: A Practical Workshop TBD
 
Tuesday, June 27
 

8:30am CDT

Illuminating Risk Minimization Effectiveness Measurement TBD Ethical Considerations for Conducting Research During Times of Disruption TBD Innovating Patient Recruitment Through Pharmacy Channels TBD ICH M11 Clinical Electronic Structured Harmonized Protocol (CeSHarP): Enabling Consistency and Information Exchange TBD The Case for Generating Synthetic Data as Real-World Data: Regulatory and Planning Perspectives  TBD Innovation Across Medical Affairs Throughout the Global Pandemic TBD Leveraging Analytics, Visualizations, and Decision Science to Drive Strategic Decision Making TBD International Regulatory Convergence and Collaboration TBD Pediatrics and the Paradox of Progress: What’s New, What’s Next, What’s Needed? TBD Office of Generic Drugs/Office of Pharmaceutical Quality Town Hall TBD

10:30am CDT

Benefit-Risk Balance for Medicinal Products: CIOMS Working Group XII Report TBD Good Recruitment Practice Under Regulation (EU) No 536/2014 TBD The Future of Regulatory Submissions: Opportunities and Challenges TBD Medical Storytelling Inserted Into All Aspects of Medical Affairs TBD Disrupting the Status Quo: Best Practices for Bringing Together Patients and Medical Staff to Positively Impact Trial Diversity TBD The Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP) Collaboratory: Facilitation of Medical Product Development for Rare Diseases TBD IMPALA (IntercoMPany quALity Analytics) Industry Consortium: Quality Analytics Use Cases and Early Health Authority Feedback TBD ANVISA Townhall TBD International Harmonization of Real-World Data/Real-World Evidence Use and Acceptance by Health Authorities: Time to Make it Right! TBD Patient Experience Data in the Label: Closing the Loop TBD Post-Pandemic Regulatory Innovation for Clinical Trials and Opportunities for Global Alignment TBD A Regulatory Pharmaceutical Quality Knowledge Management System to Improve the Availability of Quality Medicines TBD The Full Picture: Innovative Software Tools for Data Insight Generation TBD Is Mark Cuban Really Solving the Drug Pricing Problem? TBD

1:15pm CDT

Novel Methods for Signal Identification for Medicines and Medical Devices TBD Hot off the Press: Site Challenges and Solutions in Workforce and Technology TBD Meta-Collaboration to Improve Decentralized Trial Excellence: Updates from the Collaboration Landscape TBD Global Regulatory Perspectives About Real-World Data: DARWIN EU®, FDA, and Other Current Initiatives TBD Tech-Enabled Narratives: Technology Meets Process FTW (For the Win!) TBD Measuring Impact of Patient Engagement Across Research and Development TBD Using Artificial Intelligence to Illuminate Predictive Relationships and Discover Biomarkers from Clinical, Molecular, and Digital Data TBD Getting Things Done in Drug Development Using Agile Practices TBD Pharmacovigilance: Regulator's Perspectives on Quality Approaches to Additional Risk-Minimization Measures and Post-Pandemic Inspection Reflections TBD Asia Town Hall TBD Implementing Digital Health Technologies in Clinical Trials: How to Apply New Resources to Address Key Questions TBD One Dossier and One Timeline for a Post Approval Change: The Story of a Regulatory Reliance Pilot! TBD Quality in the Real World: Diagnosing and Addressing Inaccuracies and Gaps in Routinely Collected Patient Data TBD The Inflation Reduction Act Price Setting: What are the Impacts on Biopharmaceutical Innovation from Different Perspectives? TBD Demystifying the Common Legal Agreements, Key Terms, and Pitfalls for Non-Legal Professionals TBD

4:00pm CDT

Negotiating your Way Through the Vigilance Agreement Maze: Is There a Better Way? TBD Smarter Approaches to Pharmacovigilance Challenges TBD Can Pragmatic Trials Simultaneously Meet the Needs of Regulators, Payers and Clinical Care? TBD The Many Faces of In-Trial Interviews: Navigating Operational and Scientific Waters to Optimize Value for Clinical Trials TBD IDMP and Data Harmonization Methods: How Your Company will be Impacted TBD SMART-on-FHIR: Integrating Electronic Health Records as Real-World Data TBD Generating Patient Insights to Inform Health Policy Issues: Policy Patient Engagement Research Councils (PERCs) TBD An Assessment of the Challenges Associated with Cell and Gene Therapies: Are Digital Health Technologies the Way Forward? TBD Data Analytics for Quality Assurance: Shifting the Paradigm from Issue Detection to Quality Evidence Generation TBD Globally Accelerating the Drive to eLabeling for All TBD PMDA Town Hall TBD Quality Aspects of FY23-28 User Fee Agreements TBD Patient-Preferences and Multistate Models to Enhance Patient-Focus of Traditional Endpoints in Oncology TBD Improving Patient Access with Real-World Evidence: A Framework for Coverage and Formulary Decisions TBD
 
Wednesday, June 28
 

8:30am CDT

Advancing PV in Africa TBD Using Real-World Data to Evaluate Safety Signals TBD Returning Individual Participant Data: A Cultural and Operational Shift Towards Personalized Clinical Trial Options TBD Real-World Data Quality: Components and Considerations of Data Sources Used for Regulatory Decision-Making TBD The Rapidly Changing Landscape of Data Collection and its Implications for Clinical Data Management TBD Writing Summary Documents for Rare Disease Submissions: Unique Challenges TBD Leveraging Project Management Skills for Significant Drug Development Deliverables TBD Strategies for Benefit-Risk Analysis in Regulatory Submissions TBD Strategies to Make the Right Virtual Connection: Play and Learn TBD

10:30am CDT

Opportunities to Improve Risk Minimization Outcomes with Behavioral Science TBD Registries Aren’t Always the Answer: Novel Designs for Executing Post-Market Pregnancy Requirements TBD Best Practices for Managing Rare Disease Trials in Latin America as an Emerging Trial TBD Leveraging Data Scientists and Data Managers with Evolving Protocol Designs   TBD Operationalizing Real-World Data: Methods, Acceptance, and Future Hopes  TBD Is the Hype Real? Real-Life User Experience of Medical Writing Artifcial Intelligence Tools for Clinical Study Reports Production TBD Combining Qualitative and Quantitative Research to Generate Within-Patient Meaningful Changes in Clinical Outcome Assessments TBD What Can ICH Bring to the Future of Model-Informed Drug Development (MIDD)? TBD PI 1572 Responsibility and Oversight in Decentralized Clinical Trials TBD 25-Years After FDAMA: How is FDA Applying the Confirmatory Evidence Standard for Substantial Evidence of Effectiveness? TBD Dose Optimization in Oncology: How Do we Tackle the Tricky Topic of Combinations? TBD Health Canada Town Hall TBD Reliance in Action: How to Ensure Product Sameness When Using Global Supply Chains TBD Patient-Focused Drug Development in Rare Disease Endpoint Selections TBD How Real-World Data from Wearable Biosensors and Artifical Intelligence (A)I-Based Analytics Is Enabling the Shift from Efficacy to Effectiveness TBD

1:15pm CDT

Operationalizing FDA Medical Queries TBD Regulatory Insights into Decentralized Clinical Trials TBD Today’s Episode of Clinical Research Talk Explores Clinical Adjudication and Practical Applications of Artifical Intelligence and Natural Language Processing TBD Managing BYOD and Wearables in Clinical Trials: Sustainable Data Collection TBD Estimands and Designing of the Clinical Trial and Protocol Structure TBD Capturing the Patient Voice Using Longitudinal Qualitative Research Methods in Medical Product Development TBD Fostering Cross-Functional Team Success with Project Management and Alliance Management Best Practices TBD Industry and Regulators’ Experience with the Implementation and Use of Remote Consent TBD FDA Rare Disease Town Hall TBD The Future of Biosimilar and Interchangeable Biologics: Global Development, Harmonization, and the Inflation Reduction Act TBD Evolving Global Landscape for Addressing Drug Shortages: Innovative Strategies in the Area of Regulatory and Technology TBD Opportunities and Issues with Existing Analytical Technologies for Safety Monitoring of Ongoing Clinical Studies TBD Real-World Data: Maximizing Value and Quality Through End-to-End Patient Centricity TBD Performance, Interrupted: Examining Diversity, Equity, and Inclusion Dynamics that can Impact Team Performance in Drug Development TBD

4:00pm CDT

Assessing Safety in Rare Disease Gene Therapy TBD Modernizing the Clinical Trials Environment in Europe: ACT EU and the New EU Clinical Trial Regulation TBD Patient-Generated Health Data and Real-World Evidence: How Can They Be Used to Accelerate Patient Engagement and Diversity? TBD Leading Cross-Functional Teams Through Mergers, Divestments, and Acquisitions TBD Quality by Design for Real-World Evidence Studies TBD Mobilizing Cooperation with the African Medicines Agency TBD Regulatory Reliance: Addressing Gaps to Harmonize and Enhance Uptake Globally TBD Patient and Quality Impacts of Restrictions on the Use of Titanium Dioxide (TiO2) in Medicines TBD From 1000's of Tables to Summarizing Clinical Trials Graphically TBD Critically Thinking Organization: An Action-Oriented Workshop for Leaders TBD
 
Thursday, June 29
 

8:30am CDT

Implementing the Program Safety Analysis Plan and Enhancing Ongoing Aggregate Review with an Interactive Open Sourced Tool TBD Effective Use of Intelligent Automation in Clinical and Regulatory TBD A Global Sponsor Perspective on Implementation of the New EU Clinical Trials Regulation TBD The Value of Patient-Centric Communication Strategies TBD Crafting the Message: Driving Drug Development Through Compelling Governance Interactions TBD FDA Sponsor Interaction: Best Practices and New PDUFA Formal Meetings TBD International Medical Device Regulators Forum (IMDRF) and Technological Innovation: How International Medical Device Harmonization is Impacting Drug Strategy TBD Demystifying Statistical Concepts for ANYONE Involved with Clinical Trials TBD

9:45am CDT

Reporting of Pre- and Postmarket Safety Reports to FDA Adverse Event Reporting System (FAERS) Using ICH E2B Standards TBD The Other Side of the Table: Drug Development Professionals Share Their Experiences Participating as Patients in Trials TBD Process Automation and Artificial Intelligence in the Field: Practical Applications TBD Statistical Applications of Machine Learning (ML) and Artificial Intelligence (AI) in Drug Development and Success Stories of Application TBD
 
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  • 00: Plenary
  • 01 - Clinical Safety and Pharmacovigilance
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Tech in Clinical Trials
  • 04: MedAffairs-SciComm
  • 05: Patient Engagement
  • 06: PreClinical Dev-EarlyPhaseCR
  • 06 - Translational Sciences and Precision Medicine
  • 06: TranslationalScience-PrecisionMedicine
  • 07: ProjectManagement-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: Networking Opportunities
  • 18: Posters
  • 19: InnovationTheaters
  • 20: Short Courses
    • Exh Hall Community Area
    Exhibit Hall
    Exhibit Hall Booth #1719
    Exhibit Hall Theater #1
    Exhibit Hall Theater #2
    Exhibit Hall Theater #3
    Level 3 F2 Entrance
    Meeting Rm Lobby Level 1
    Meeting Room Lobby
    Room 175
    Room 176
    Room 178
    Room 179
    Room 180
    Room 183 A
    Room 183 B
    Room 183 C
    Room 184
    Room 185 AB
    Room 185 CD
    Room 186
    Room 187
    Room 375 A Zone 1
    Room 375 A Zone 2
    Room 470 A
    Room 470 B
    Room 471 A
    Room Skyline 375 CDE
    Skyline Ballroom Foyer
    TBD
    Virtual