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Monday, June 12
 

9:30am EDT

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

1:00pm EDT

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

9:30am EDT

21A: Signal Management in Pharmacovigilance Virtual

1:00pm EDT

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

9:30am EDT

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

1:00pm EDT

32P: Talking Statistics: Interpreting Statistical Results for Non-Statisticians Involved with Clinical Trials Virtual
 
Thursday, June 15
 

9:30am EDT

41A: Digitalization of the Submission Pathway for Combination Products Virtual
 
Sunday, June 25
 

9:00am EDT

51F: Toolkit Approach to Best Practices in Root Cause Analysis and CAPA Management Workshop TBD 52F: Ecosystem of Digital and Data Innovation Partnerships: Generating Regulatory Grade Evidence in Diverse Patient Populations TBD
 
Monday, June 26
 

9:00am EDT

Opening Plenary: Revolutionizing Life Sciences - How Diversity, Innovation, and Artificial Intelligence are Accelerating the Future of Health

10:45am EDT

Artificial Intelligence: Delivering on the Promise TBD Sponsor-CRO Collaborations and the Impact of Decentralized Clinical Trials TBD Risk-Based Monitoring in Clinical Trials: A Four-Year Analysis TBD Disruptive Medicine Innovation: Combination Products TBD Navigating the Constellation of Efforts to Increase Representation in Clinical Research TBD Inspired by Big-Tech and Humbled by Complexity of Clinical Research: Clinical Trial Digital Transformation TBD Applying Implementation Science Methods to Generate Evidence to Improve Access to New Therapeutics: What has Been Learned? TBD E9(R1) Implementation: Practical Applications of Using Estimands in Protocols, SAPs, Data Standards and Examples of use of Estimands TBD What’s in the Future for Global Advancements in Patient Engagement and Patient-Focused Medical Product Development? TBD Cell and Gene Therapies Pulse Check TBD New Alternative Methods-Only IND/CTA Application: Distant Dream or Immediate Possibility? TBD Moving Into and Advancing In a Project Management Career TBD Data Analytics for Quality Assurance: Shifting the Paradigm from Issue Detection to Quality Evidence Generation TBD Negotiating your Next Offer TBD

12:05pm EDT

Advanced Clinical Innovation Theater: Where Are We, and Where Do We Need to Be? A Multistakeholder Look at the Clinical Research Talent Market Exhibit Hall Theater #2 IQVIA Innovation Theater: Exhibit Hall Theater #1 Yseop Innovation Theater: Exhibit Hall Theater #3

12:45pm EDT

Datacubed Health Innovation Theater: Exhibit Hall Theater #3 Deloitte Innovation Theater: Exhibit Hall Theater #1 RWS Innovation Theater: Exhibit Hall Theater #2

1:30pm EDT

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 Advances in Real-World Evidence: Real-World Data Hybrid Randomized Clinical Trials, Publication Scandal, and China’s Real-World Evidence Heaven TBD Innovative Digital Health Technologies: Strategies for Successful Integrations, Quality, and Compliance TBD Building Trust: Data Privacy in Decentralized Clinical Trials TBD On the Path to Enlightened Conversations: Setting up Structured Content Authoring TBD Beyond the Why: How to Effectively Implement a Patient-Led Approach to Clinical Trial Design and Conduct TBD Contemporary Challenges in Personalized Medicine and Companion Diagnostics TBD Unleashing the Fearless Quality Professional 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 Combating Misinformation with Authoritative Medical Product Information TBD Novel Biomarkers and Surrogate Endpoints in a Rare Disease TBD International Collaboration for Pharmaceutical Quality and Manufacturing Agility TBD Do Surrogate Endpoints Expedite or Hinder Payer Coverage of Drugs? TBD

2:50pm EDT

H1 Innovation Theater: A Race to The Finish in Trial Success - Diversity, Feasibility, and Site Selection Exhibit Hall Theater #3 Parexel Innovation Theater: Early Planning for Clinical Trial Diversity - How Upfront Strategies Avoid Additional Time and Cost Exhibit Hall Theater #1 PPD part of Thermo Fisher Scientific Innovation Theater: Exploring New Perspectives to Optimize Clinical Trial Design Exhibit Hall Theater #2

3:30pm EDT

SAS Institute Innovation Theater: Overcoming Clinical Operations Challenges from Protocol Design to Submission Exhibit Hall Theater #2 eClinical Solutions Innovation Theater: Exhibit Hall Theater #1

4:15pm EDT

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 Creating your Career Plan 101: A Practical Workshop TBD Digital Endpoints in Clinical Trials: Qualifications, Collaborations, and Risk-Based Approaches TBD The True Decentralization of Clinical Trials: Benefits and Drawbacks of Blockchain Technology TBD Supporting Providers in Value-Based Contracts: Machine Learning and Recursive Neural Networks for Outcomes and Treatment Journey Optimization 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 IMPALA (IntercoMPany quALity Analytics) Industry Consortium: Quality Analytics Use Cases and Early Health Authority Feedback TBD Emerging Therapies and Technologies: 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

5:30pm EDT

CRIO Innovation Theater: It’s all About the Sites! Sponsors - Reimagine your Approach to Clinical Trials Exhibit Hall Theater #1
 
Tuesday, June 27
 

8:30am EDT

Full Exposure: Artificial Intelligence to Advance, Replace, and Add Efficiency for Patient Benefit TBD Completing the Risk Management Cycle: Review of Risk Management Effectiveness 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 Utilizing Analytics, Visualizations, and Decision Science to Drive Strategic Decision Making TBD International Regulatory Convergence and Collaboration TBD NMPA Town Hall 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

9:45am EDT

Clario Innovation Theater: Go Slow to go Fast - Strategies and Techniques for Expanding Inclusion in Flexible Clinical Trials (DCT, Hybrid, etc.) Exhibit Hall Theater #2 Flatiron Innovation Theater: Exhibit Hall Theater #1 Merative Innovation Theater: Decentralized Clinical Trials are Here to Stay – But how do we Work to Execute them Smoothly? Exhibit Hall Theater #3

10:30am EDT

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 Time for Alignment? A Policy Landscape Update on the Use and Acceptance of Real-World Data/Real-World Evidence for Regulatory Purposes TBD The Full Picture: Innovative Software Tools for Data Insight Generation 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 How to Make Good Decisions Quickly TBD One Year On: How Quality Briefs are Transforming the Approach to Quality and Driving Innovation to Serve Patients TBD ANVISA Town Hall TBD Post-Pandemic Regulatory Innovation for Clinical Trials and Opportunities for Global Alignment TBD Patient Experience Data in the Label: Closing the Loop TBD A Regulatory Pharmaceutical Quality Knowledge Management System to Improve the Availability of Quality Medicines TBD Is Mark Cuban Really Solving the Drug Pricing Problem? TBD

11:50am EDT

Deep 6 AI Innovation Theater: Unlocking the Power of a Precision Research Ecosystem - Enhancing Decision-Making with Deep 6 AI's Clinical Trial Acceleration Software Exhibit Hall Theater #3 Deloitte Innovation Theater: Exhibit Hall Theater #2 Quest Innovation Theater: Exhibit Hall Theater #1

12:30pm EDT

endpoint Clinical Innovation Theater: How to Get the Most Out of Your Diversified Digital Network Exhibit Hall Theater #2 Medable Innovation Theater: Better Together - How Industry Leaders are Shaping a New Era of Drug Development Exhibit Hall Theater #3 IQVIA Innovation Theater: Exhibit Hall Theater #1

1:15pm EDT

Novel Methods for Signal Identification for Medicines and Medical Devices TBD Meta-Collaboration to Improve Decentralized Trial Excellence: Updates from the Collaboration Landscape TBD Hot off the Press: Site Challenges and Solutions in Workforce and Technology TBD Global Regulatory Perspectives About Real-World Data: DARWIN EU®, FDA, and Other Current Initiatives TBD Quality in the Real World: Identifying and Addressing Inaccuracies and Gaps in Routinely Collected Patient Data TBD Tech-Enabled Narratives: Technology Meets Process FTW (For the Win!) TBD Measuring Impact of Patient Engagement Across Research and Development TBD Agile Project Management Practitioners Tackle Challenges Within the Life Sciences TBD Biotech Operations and Venture Funding: Key Legal Considerations 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 The Inflation Reduction Act Price Setting: What are the Impacts on Biopharmaceutical Innovation from Different Perspectives? TBD

2:35pm EDT

Calyx Innovation Theater: Experience of Using Artificial Intelligence Technology to Identify Biomarkers in Clinical Trials Exhibit Hall Theater #3 Fortrea Innovation Theater: Key Components to Achieving Patient-Centric Trial Design - How the Pandemic Unlocked the Potential for Flexibility in Trial Execution Exhibit Hall Theater #2 Parexel Innovation Theater: Scaling Large Language Models in Clinical Research for Unprecedented Efficiencies Exhibit Hall Theater #1

3:15pm EDT

UBC Innovation Theater: Exhibit Hall Theater #2

4:00pm EDT

Smarter Approaches to Pharmacovigilance Challenges TBD Negotiating your Way Through the Vigilance Agreement Maze: Is There a Better Way? TBD The Many Faces of In-Trial Interviews: Navigating Operational and Scientific Waters to Optimize Value for Clinical Trials TBD Patient-Preferences and Multistate Models to Enhance Patient-Focus of Traditional Endpoints in Oncology TBD SMART-on-FHIR: Integrating Electronic Health Records as Real-World Data TBD IDMP Standards, Structured Submissions, and Data Harmonization Methods: How Will Your Company will be Impacted? TBD On the Path to Enlightened Conversations: Implementing Structured Content Authoring (Part 2) TBD Globally Accelerating the Drive to eLabeling for All TBD An Assessment of the Challenges Associated with Cell and Gene Therapies: Are Digital Health Technologies the Way Forward? TBD Modernizing Clinical Trials: A Regulatory Perspective TBD Quality Aspects of FY23-28 User Fee Agreements TBD PMDA Town Hall TBD Improving Patient Access with Real-World Evidence: A Framework for Coverage and Formulary Decisions TBD
 
Wednesday, June 28
 

8:30am EDT

Pharmacovigilance in Africa: Nigeria and Ghana Health Authorities Share their Perspectives TBD Using Real-World Data to Evaluate Safety Signals TBD Strategies for Benefit-Risk Analysis in Regulatory Submissions 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 A Case Study for Illumined Therapeutic Development: Shining the Light on ALS TBD Leveraging Project Management Skills for Significant Drug Development Deliverables TBD Strategies to Make the Right Connections and Developing Relationships in a Virtual Network TBD

9:45am EDT

Evernorth Innovation Theater: Inclusive Clinical Trial Site Planning Using Social Determinants of Health (SDoH) Exhibit Hall Theater #1 Lokavant Innovation Theater: Exhibit Hall Theater #2

10:30am EDT

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 Region TBD Operationalizing Real-World Data: Methods, Acceptance, and Future Hopes  TBD Leveraging Data Scientists and Data Managers in Clinical Data Management TBD How Real-World Data from Wearable Biosensors and Artificial Intelligence (A)I-Based Analytics Is Enabling the Shift from Efficacy to Effectiveness 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 Health Canada Town Hall TBD Dose Optimization in Oncology: How Do we Tackle the Tricky Topic of Combinations? 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

11:50am EDT

IQVIA Innovation Theater: Long Term Follow up for Cell and Gene Therapies – Real-World Approaches to Drive Success Exhibit Hall Theater #1

1:15pm EDT

Operationalizing FDA Medical Queries 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 Regulatory Insights into Decentralized Clinical Trials TBD The Future of Biosimilar and Interchangeable Biologics: Global Development, Harmonization, and the Inflation Reduction Act TBD Managing BYOD and Wearables in Clinical Trials: Sustainable Data Collection TBD Real-World Data Standards and Protocol Designs for Information Exchange and Data Flow  TBD Introduction to Estimands and Incorporation of the Estimand Framework in Protocols TBD Capturing the Patient Voice Using Longitudinal Qualitative Research Methods in Medical Product Development TBD Fostering Cross-Functional Team Success by Leveraging Project Management and Alliance Management Best Practices TBD Performance, Interrupted: Examining Diversity, Equity, and Inclusion Dynamics that can Impact Team Performance in Drug Development TBD Industry and Regulators’ Experience with the Implementation and Use of Remote Consent TBD FDA Rare Disease Town Hall TBD Evolving Global Landscape for Addressing Drug Shortages: Innovative Technology and Regulatory Strategies TBD

4:00pm EDT

Assessing Safety in Rare Disease and Gene Therapy 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 and Visualizing Analyses Interactively TBD Can Pragmatic Trials Simultaneously Meet the Needs of Regulators, Payers, and Clinical Care? TBD Critically Thinking Organization: An Action-Oriented Workshop for Leaders TBD Modernizing the Clinical Trials Environment in Europe: ACT EU and the New EU Clinical Trial Regulation TBD Ethics-by-Design: Embedding Ethics into Uses of Data and Artificial Intelligence in the Pharmaceutical Industry 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 ICH Work to Harmonize Requirements for Safe and Effective Medicines: What’s in It for Patients? TBD
 
Thursday, June 29
 

8:30am EDT

Implementing the Program Safety Analysis Plan and Enhancing Ongoing Aggregate Review with an Interactive Open-Sourced Tool TBD Reverse-Engineering Digital Endpoints to Improve Trial Design and Expand Diversity and Access TBD Demystifying Statistical Concepts for ANYONE Involved with Clinical Trials TBD Effective Use of Intelligent Automation in Clinical and Regulatory TBD Implementation of the New EU Clinical Trials Regulation TBD CIOMS: What it Does and the Guideline on Patient Involvement in the Development, Regulation, and Safe Use of Medicines TBD The Value of Patient-Centric Communication Strategies TBD Crafting the Message: Driving Drug Development Through Compelling Governance Interactions TBD ACCESS Consortium: What's Next? 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

9:45am EDT

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 EMA-FDA Question Time TBD

11:15am EDT

FDA Town Hall TBD
 
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  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
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  • 05: Patient Engagement
  • 06: TranslationalScience-PrecisionMedicine
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  • 19: InnovationTheaters
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Monday, June 12
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  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient Engagement
  • 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
  • 19: InnovationTheaters
  • 20: Short Courses
    • Exhibit Hall Theater #1
    Exhibit Hall Theater #2
    Exhibit Hall Theater #3
    TBD
    Virtual