Pharma药企

16: InnovationTheaters

#401.1 IT: Box Innovation Theater: From Digital Debt to Strategic Asset - Making Regulated Clinical Content AI-Ready

#401.1 · IT

Pharma药企

03: Data-Tech-AI

#407: The Great Debate: Using AI in Patient-Facing Materials

#407

Pharma药企

06: ProfDevelop-Program-PortfolioMgmt

#410: Managing What Matters: Turning Project Decisions into Portfolio Impact in R&D and Medical

#410

Pharma药企

03: Data-Tech-AI

#406: Enhancing Regulatory Collaboration through Cloud Technologies

#406

Pharma药企

01: ClinSafety-PV-RM

#402: Future Vigilance Approaches: What Data Sources will have the Biggest Impact on Patient Care?

#402

Pharma药企

02: ClinicalTrialOps-Innovation

#404: Evidence-Based Insights Informing Participant Compensation Strategies

#404

Pharma药企

06: ProfDevelop-Program-PortfolioMgmt

#414: How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency

#414

Pharma药企

07: RegCMC-Product Quality

#411: Accelerating US Based Domestic Manufacturing by Leveraging Innovative Regulatory Concepts

#411

Pharma药企

05: PersonalizedMed-ComboProd-Diagnostics

#408: Combined Clinical Trials: A Focus on In Vitro Diagnostics

#408

Pharma药企

07: RegCMC-Product Quality

#411: Accelerating US Based Domestic Manufacturing by Leveraging Innovative Regulatory Concepts

#411

Pharma药企

05: PersonalizedMed-ComboProd-Diagnostics

#408: Combined Clinical Trials: A Focus on In Vitro Diagnostics

#408

Pharma药企

02: ClinicalTrialOps-Innovation

#403: Clinical Operations in Transition: Leadership Perspectives on AI, the Workforce, and the Future of Trial Execution

#403

Pharma药企

07: RegCMC-Product Quality

#411: Accelerating US Based Domestic Manufacturing by Leveraging Innovative Regulatory Concepts

#411

Pharma药企

02: ClinicalTrialOps-Innovation

#417: A Holistic Approach to Achieve Fit for Purpose Clinical Trial: Integrating a Function-Agnostic End-to-End Quality by Design and Risk-Based Quality Management Strategy

#417

Pharma药企

06: ProfDevelop-Program-PortfolioMgmt

#409: Evolving Role of the Quality Professional: The Future of Professional Development in the Age of AI

#409

Pharma药企

08: RegPolicy-Strategy-GlobalCollaboration

#412: FDA Public Posting of Complete Response Letters: A Year in Review, Trends, and Impact Analysis

#412

Pharma药企

08: RegPolicy-Strategy-GlobalCollaboration

#416: Transforming Women’s Health Science: Closing the Innovation Gap and Accelerating Impact

#416

Pharma药企

03: Data-Tech-AI

#434: Next-Generation Data Standards for Real-World Data and Real-World Evidence (FHIR, Dataset-JSON, and the Road Ahead)

#434

Pharma药企

08: RegPolicy-Strategy-GlobalCollaboration

#439.1: From Lag to Lead: Accelerating Global Innovative Medicines Through China’s NMPA

#439.1

Pharma药企

03: Data-Tech-AI

#442: The State of Artificial Intelligence in Regulatory Review and Decision-Making: Perspectives from FDA, EMA, and PMDA

#442

Pharma药企

03: Data-Tech-AI

#433: ICH M11 in Action: Digital Protocols, AI, and Cloud for Patient-Centered Regulatory Science

#433

Pharma药企

08: RegPolicy-Strategy-GlobalCollaboration

#439.1: From Lag to Lead: Accelerating Global Innovative Medicines Through China’s NMPA

#439.1

Pharma药企

09: RD-Quality-Compliance

#443: The Quality Blueprint: How Cross-Functional Leadership and Employee Ownership Drive Clinical Trial Excellence

#443

Pharma药企

10: Stats-EvidenceGeneration-RWE

#444: Driving Efficiency in Clinical Development with Master Protocols

#444

Pharma药企

02: ClinicalTrialOps-Innovation

#431: Expanding Access and Engagement: Lessons from Decentralized Clinical Trial Solutions

#431

Pharma药企

03: Data-Tech-AI

#437: Opportunity, Caution or Reluctance: Global Trends for Regulating AI in Pharmaceutical Manufacturing

#437

Pharma药企

09: RD-Quality-Compliance

#443: The Quality Blueprint: How Cross-Functional Leadership and Employee Ownership Drive Clinical Trial Excellence

#443

Pharma药企

02: ClinicalTrialOps-Innovation

#432: Industry Collaboration 2030: Head, Heart and Gut Perspectives

#432

Pharma药企

08: RegPolicy-Strategy-GlobalCollaboration

#440: Harnessing International Regulatory Reliance and Collaboration to Accelerate Innovation and Patient Access to Medicines

#440

Pharma药企

03: Data-Tech-AI

#437: Opportunity, Caution or Reluctance: Global Trends for Regulating AI in Pharmaceutical Manufacturing

#437

Pharma药企

01: ClinSafety-PV-RM

#430: Responsible use of AI in Pharmacovigilance: Global Perspectives from CIOMS WG XIV

#430

Pharma药企

04: MedAffairs-SciComm

#435: AI Competency Framework for Medical Writers: Essential Skills to Enhance Medical Writing AI Expertise

#435

Pharma药企

04: MedAffairs-SciComm

#435: AI Competency Framework for Medical Writers: Essential Skills to Enhance Medical Writing AI Expertise

#435

Pharma药企

10: Stats-EvidenceGeneration-RWE

#444: Driving Efficiency in Clinical Development with Master Protocols

#444

Pharma药企

08: RegPolicy-Strategy-GlobalCollaboration

#440: Harnessing International Regulatory Reliance and Collaboration to Accelerate Innovation and Patient Access to Medicines

#440

Pharma药企

10: Stats-EvidenceGeneration-RWE

#444: Driving Efficiency in Clinical Development with Master Protocols

#444

Pharma药企

02: ClinicalTrialOps-Innovation

#432: Industry Collaboration 2030: Head, Heart and Gut Perspectives

#432

Pharma药企

08: RegPolicy-Strategy-GlobalCollaboration

#439.1: From Lag to Lead: Accelerating Global Innovative Medicines Through China’s NMPA

#439.1

Pharma药企

03: Data-Tech-AI

#448: Accelerating Regulatory Readiness: A Vision for AI-Enabled Pandemic Preparedness

#448

Pharma药企

03: Data-Tech-AI

#450: Medical Writing Ted Experience

#450

Pharma药企

07: RegCMC-Product Quality

#453: Navigating CMC Challenges for Innovative Cell and Gene Therapy Products: From Starting Materials to Comparability

#453

Pharma药企

06: ProfDevelop-Program-PortfolioMgmt

#452: Mentorship Myth Busters: Moving Beyond Misconceptions

#452

Pharma药企

02: ClinicalTrialOps-Innovation

#447: Enabling Faster Multi-Regional Study Start-Up Through Harmonization and Collaboration

#447

Pharma药企

07: RegCMC-Product Quality

#453: Navigating CMC Challenges for Innovative Cell and Gene Therapy Products: From Starting Materials to Comparability

#453

Pharma药企

02: ClinicalTrialOps-Innovation

#460: Is There an Urgent Need for Global Alignment on External Controls in Clinical Trials?

#460

Pharma药企

10: Stats-EvidenceGeneration-RWE

#459: Bias and Methodological Challenges in External Control Arms Addressing Time-Related Bias, Endpoint Alignment, Unmeasured Confounding

#459

Pharma药企

08: RegPolicy-Strategy-GlobalCollaboration

#457: Understanding the Misconceptions and Myths around Surrogate Endpoints

#457

Pharma药企

08: RegPolicy-Strategy-GlobalCollaboration

#457: Understanding the Misconceptions and Myths around Surrogate Endpoints

#457

Pharma药企

08: RegPolicy-Strategy-GlobalCollaboration

#456: Middle East Town Hall: The Rising Global Innovation Hub - Aligning Regulations and Unlocking Fresh Opportunities

#456

Pharma药企

02: ClinicalTrialOps-Innovation

#447: Enabling Faster Multi-Regional Study Start-Up Through Harmonization and Collaboration

#447

Pharma药企

02: ClinicalTrialOps-Innovation

#454: Accelerating Pediatric Innovation: Leveraging Extrapolation and Global Policy to Transform Drug Development for Children

#454

Pharma药企

07: RegCMC-Product Quality

#453: Navigating CMC Challenges for Innovative Cell and Gene Therapy Products: From Starting Materials to Comparability

#453

Pharma药企

02: ClinicalTrialOps-Innovation

#460: Is There an Urgent Need for Global Alignment on External Controls in Clinical Trials?

#460

Pharma药企

00: Plenary

#500: Transforming Obesity Patient Care: Past, Present, and Future Innovation in the Age of GLP-1 Therapies

#500

Pharma药企

00: Plenary

#500: Transforming Obesity Patient Care: Past, Present, and Future Innovation in the Age of GLP-1 Therapies

#500

Pharma药企

16: InnovationTheaters

#501 IT: Weave Bio Innovation Theater: Threading AI Throughout the Drug Development Lifecycle - An Enterprise Lens

#501 · IT

Pharma药企

07: RegCMC-Product Quality

#512: Enhanced Analytical Procedure Development: Principles, Prior Knowledge, and Change Management

#512

Pharma药企

02: ClinicalTrialOps-Innovation

#506: From Barriers to Bridges: Unlocking Research Potential in Primary Care

#506

Pharma药企

02: ClinicalTrialOps-Innovation

#513: Advancing Chronic Disease Development: Insights from FDA, EMA, PMDA, and MHRA

#513

Pharma药企

09: RD-Quality-Compliance

#518: Next Generation Clinical Trial Quality Assurance Using Advanced Analytics

#518

Pharma药企

07: RegCMC-Product Quality

#512: Enhanced Analytical Procedure Development: Principles, Prior Knowledge, and Change Management

#512

Pharma药企

07: RegCMC-Product Quality

#512: Enhanced Analytical Procedure Development: Principles, Prior Knowledge, and Change Management

#512

Pharma药企

02: ClinicalTrialOps-Innovation

#511: AI Risk Scores and Regulatory Forks: Diagnose Your Software’s Regulatory Fate

#511

Pharma药企

08: RegPolicy-Strategy-GlobalCollaboration

#516: Modernizing Nonclinical Safety Assessment: FDA and EMA Roadmaps to Reduce Animal Testing

#516

Pharma药企

09: RD-Quality-Compliance

#518: Next Generation Clinical Trial Quality Assurance Using Advanced Analytics

#518

Pharma药企

02: ClinicalTrialOps-Innovation

#511: AI Risk Scores and Regulatory Forks: Diagnose Your Software’s Regulatory Fate

#511

Pharma药企

03: Data-Tech-AI

#514: Innovation Gridlock: When Misaligned Policies Threaten Progress for Patients

#514

Pharma药企

02: ClinicalTrialOps-Innovation

#506: From Barriers to Bridges: Unlocking Research Potential in Primary Care

#506

Pharma药企

02: ClinicalTrialOps-Innovation

#510: The Trials and Virtues of Founder Led Selling: Rapid Discovery and Validation of Product-Market Fit for ClinTech

#510

Pharma药企

01: ClinSafety-PV-RM

#504: From Conventional to Intelligent: Redefining Pharmacovigilance with AI and Global Collaboration

#504

Pharma药企

02: ClinicalTrialOps-Innovation

#507: Paying Fair: Regulatory and Ethical Challenges in Research Participant Compensation

#507

Pharma药企

09: RD-Quality-Compliance

#518: Next Generation Clinical Trial Quality Assurance Using Advanced Analytics

#518

Pharma药企

03: Data-Tech-AI

#514: Innovation Gridlock: When Misaligned Policies Threaten Progress for Patients

#514

Pharma药企

03: Data-Tech-AI

#508: How Standardized Protocol Data Plus AI Power Patient Centric Studies

#508

Pharma药企

02: ClinicalTrialOps-Innovation

#511: AI Risk Scores and Regulatory Forks: Diagnose Your Software’s Regulatory Fate

#511

Pharma药企

08: RegPolicy-Strategy-GlobalCollaboration

#517: Navigating the New FDA: Insights from Former FDA Chief of Staffs

#517

Pharma药企

07: RegCMC-Product Quality

#512: Enhanced Analytical Procedure Development: Principles, Prior Knowledge, and Change Management

#512

Pharma药企

14: Posters

#520 POS: Professional Poster Session II

#520 · POS

Pharma药企

16: InnovationTheaters

#524 IT: Vivpro Corporation Innovation Theater: AI in Action - Scaling Regulatory Document Generation Across R&D

#524 · IT

Pharma药企

08: RegPolicy-Strategy-GlobalCollaboration

#538: Innovations in Drug Review: A Global Perspective

#538

Pharma药企

02: ClinicalTrialOps-Innovation

#543: Global Regulatory Perspectives on Bayesian Design and Analysis Informing Regulatory Decision Making

#543

Pharma药企

03: Data-Tech-AI

#532: Applied Innovation for Patients: Implementing AI, Cloud, and Data in Regulatory Science

#532

Pharma药企

02: ClinicalTrialOps-Innovation

#529: Early Outcomes and Strategic Learnings from the DIA Obesity Consortium’s Initial Collaborative Phase

#529

Pharma药企

02: ClinicalTrialOps-Innovation

#530: The Synthetic AI Patient Persona: Augmenting Patient Centricity in Clinical Trials

#530

Pharma药企

09: RD-Quality-Compliance

#542: Quality by Design Revolution: Is There Still a Place for Traditional Clinical Trial Functions?

#542

Pharma药企

02: ClinicalTrialOps-Innovation

#530: The Synthetic AI Patient Persona: Augmenting Patient Centricity in Clinical Trials

#530

Pharma药企

03: Data-Tech-AI

#533: Is Your AI Ready to Scale? Build the Governance Backbone for Reliable Innovation and Trust

#533

Pharma药企

02: ClinicalTrialOps-Innovation

#529: Early Outcomes and Strategic Learnings from the DIA Obesity Consortium’s Initial Collaborative Phase

#529

Pharma药企

02: ClinicalTrialOps-Innovation

#529: Early Outcomes and Strategic Learnings from the DIA Obesity Consortium’s Initial Collaborative Phase

#529

Pharma药企

02: ClinicalTrialOps-Innovation

#529: Early Outcomes and Strategic Learnings from the DIA Obesity Consortium’s Initial Collaborative Phase

#529

Pharma药企

09: RD-Quality-Compliance

#542: Quality by Design Revolution: Is There Still a Place for Traditional Clinical Trial Functions?

#542

Pharma药企

03: Data-Tech-AI

#533: Is Your AI Ready to Scale? Build the Governance Backbone for Reliable Innovation and Trust

#533

Pharma药企

06: ProfDevelop-Program-PortfolioMgmt

#536: Project Management as a Catalyst for Enterprise Transformation

#536

Pharma药企

06: ProfDevelop-Program-PortfolioMgmt

#536: Project Management as a Catalyst for Enterprise Transformation

#536

Pharma药企

04: MedAffairs-SciComm

#539: Labeling as a Strategic Asset: Advancing Patient Voice and Creating Value Through Meaningful Product Communication

#539

Pharma药企

08: RegPolicy-Strategy-GlobalCollaboration

#538: Innovations in Drug Review: A Global Perspective

#538

Pharma药企

04: MedAffairs-SciComm

#539: Labeling as a Strategic Asset: Advancing Patient Voice and Creating Value Through Meaningful Product Communication

#539

Pharma药企

03: Data-Tech-AI

#532: Applied Innovation for Patients: Implementing AI, Cloud, and Data in Regulatory Science

#532

Pharma药企

03: Data-Tech-AI

#533: Is Your AI Ready to Scale? Build the Governance Backbone for Reliable Innovation and Trust

#533

Pharma药企

05: PersonalizedMed-ComboProd-Diagnostics

#553: Latest in Combination Product Industry Trends: Development and Submission Strategies for Success

#553

Pharma药企

05: PersonalizedMed-ComboProd-Diagnostics

#553: Latest in Combination Product Industry Trends: Development and Submission Strategies for Success

#553

Pharma药企

08: RegPolicy-Strategy-GlobalCollaboration

#557: Advancing Global Regulatory Harmonization for Cell and Gene Therapies: Enhancing Access and Innovation

#557

Pharma药企

01: ClinSafety-PV-RM

#561: Unlocking Transformative Value: AI and Advanced Analytics in Good Clinical Practice and Good Pharmacovigilance Practice Quality Assurance

#561

Pharma药企

02: ClinicalTrialOps-Innovation

#559: China Town Hall

#559

Pharma药企

07: RegCMC-Product Quality

#555: Adapting Regulatory Frameworks to Address Mass Distribution of Unapproved or Unauthorized Medicines

#555

Pharma药企

04: MedAffairs-SciComm

#552: Optimizing the Content Ecosystem Through Lean Authoring: A Framework to Meet Regulatory Expectations and Prepare to Automate

#552

Pharma药企

08: RegPolicy-Strategy-GlobalCollaboration

#560: Novel Endpoints, Biomarkers, and Digital Tools: Strategies for Regulatory Acceptance and Scientific Alignment

#560

Pharma药企

02: ClinicalTrialOps-Innovation

#548: Clinical Research Training for Community Cancer Centers: A Pilot to Extend Clinical Trials into Diverse Catchment Areas

#548

Pharma药企

05: PersonalizedMed-ComboProd-Diagnostics

#563: Oncology Pathways Under Pressure: From CAR-T Access Today to Longevity-Driven Care Tomorrow

#563

Pharma药企

05: PersonalizedMed-ComboProd-Diagnostics

#553: Latest in Combination Product Industry Trends: Development and Submission Strategies for Success

#553

Pharma药企

08: RegPolicy-Strategy-GlobalCollaboration

#558: Advancing Pediatric Drug Development in Asia through Real-World Evidence and Regulatory Innovation

#558

Pharma药企

04: MedAffairs-SciComm

#552: Optimizing the Content Ecosystem Through Lean Authoring: A Framework to Meet Regulatory Expectations and Prepare to Automate

#552

Pharma药企

05: PersonalizedMed-ComboProd-Diagnostics

#553: Latest in Combination Product Industry Trends: Development and Submission Strategies for Success

#553

Pharma药企

01: ClinSafety-PV-RM

#561: Unlocking Transformative Value: AI and Advanced Analytics in Good Clinical Practice and Good Pharmacovigilance Practice Quality Assurance

#561

Pharma药企

08: RegPolicy-Strategy-GlobalCollaboration

#560: Novel Endpoints, Biomarkers, and Digital Tools: Strategies for Regulatory Acceptance and Scientific Alignment

#560

Pharma药企

07: RegCMC-Product Quality

#611: Future of Enhanced Product Development: Enabled Through new ICH Guidelines

#611

Pharma药企

02: ClinicalTrialOps-Innovation

#612: Achieving Regulatory-Grade Pragmatism in Streamlined Trials Embedded in Clinical Practice

#612

Pharma药企

03: Data-Tech-AI

#606: Enhancing Clinical Trial Oversight: Using Statistical Outlier Detection with Generative AI for Protocol Deviation Analysis

#606

Pharma药企

03: Data-Tech-AI

#606: Enhancing Clinical Trial Oversight: Using Statistical Outlier Detection with Generative AI for Protocol Deviation Analysis

#606

Pharma药企

02: ClinicalTrialOps-Innovation

#604: Counting the Cost: Translating Participant Burden into Fair Compensation

#604

Pharma药企

03: Data-Tech-AI

#606: Enhancing Clinical Trial Oversight: Using Statistical Outlier Detection with Generative AI for Protocol Deviation Analysis

#606

Pharma药企

06: ProfDevelop-Program-PortfolioMgmt

#610: From Dysfunctions to Dynamics: Mapping Hidden Assumptions to Strengthen Trust, Debate, and Accountability

#610

Pharma药企

08: RegPolicy-Strategy-GlobalCollaboration

#615: Navigating the FDA Commissioner's National Priority Voucher Program: Implementation Insights and Strategic Impact

#615

Pharma药企

02: ClinicalTrialOps-Innovation

#616: How to Accelerate Utilization of Decentralized Clinical Trial: What are Issues to Perform Decentralized Clinical Trial?

#616

Pharma药企

07: RegCMC-Product Quality

#611: Future of Enhanced Product Development: Enabled Through new ICH Guidelines

#611

Pharma药企

02: ClinicalTrialOps-Innovation

#603: Case Studies on AI-Enabled and Analytical Practices and Solutions Reducing Site and Participant Burden in Clinical Trials

#603

Pharma药企

07: RegCMC-Product Quality

#611: Future of Enhanced Product Development: Enabled Through new ICH Guidelines

#611

Pharma药企

02: ClinicalTrialOps-Innovation

#612: Achieving Regulatory-Grade Pragmatism in Streamlined Trials Embedded in Clinical Practice

#612

Pharma药企

02: ClinicalTrialOps-Innovation

#612: Achieving Regulatory-Grade Pragmatism in Streamlined Trials Embedded in Clinical Practice

#612

Pharma药企

02: ClinicalTrialOps-Innovation

#603: Case Studies on AI-Enabled and Analytical Practices and Solutions Reducing Site and Participant Burden in Clinical Trials

#603

Pharma药企

08: RegPolicy-Strategy-GlobalCollaboration

#615: Navigating the FDA Commissioner's National Priority Voucher Program: Implementation Insights and Strategic Impact

#615

Pharma药企

03: Data-Tech-AI

#606: Enhancing Clinical Trial Oversight: Using Statistical Outlier Detection with Generative AI for Protocol Deviation Analysis

#606

Pharma药企

06: ProfDevelop-Program-PortfolioMgmt

#610: From Dysfunctions to Dynamics: Mapping Hidden Assumptions to Strengthen Trust, Debate, and Accountability

#610

Pharma药企

08: RegPolicy-Strategy-GlobalCollaboration

#615: Navigating the FDA Commissioner's National Priority Voucher Program: Implementation Insights and Strategic Impact

#615

Pharma药企

05: PersonalizedMed-ComboProd-Diagnostics

#630: Streamlining Regulatory Frameworks for Complex Generic Development: Global Extractables and Leachables Harmonization

#630

Pharma药企

08: RegPolicy-Strategy-GlobalCollaboration

#636: The Next Frontier: Autoimmune Cell and Gene Therapy, Regulation, and Patient Access

#636

Pharma药企

04: MedAffairs-SciComm

#634: Access Unlocked: Collaborative Strategies for Navigating Regulatory and Payor Landscapes

#634

Pharma药企

03: Data-Tech-AI

#625: Building AI Governance Frameworks: Classification, Validation and Regulatory Alignment in Life Sciences

#625

Pharma药企

04: MedAffairs-SciComm

#634: Access Unlocked: Collaborative Strategies for Navigating Regulatory and Payor Landscapes

#634

Pharma药企

02: ClinicalTrialOps-Innovation

#624: Optimizing Protocol Data Collection to Reduce Site and Patient Participation Burden

#624

Pharma药企

09: RD-Quality-Compliance

#637: Destigmatizing 483 Observations

#637

Pharma药企

06: ProfDevelop-Program-PortfolioMgmt

#631: Bold Leadership: Embolden Your Team for Smart Risk-Taking

#631

Pharma药企

06: ProfDevelop-Program-PortfolioMgmt

#632: Program Manager: Jack of All Trades, Master of None?

#632

Pharma药企

02: ClinicalTrialOps-Innovation

#627: Patient-Directed Data Sharing: Enabling Innovations While Including Patients in Decisions about Secondary Data Use

#627

Pharma药企

06: ProfDevelop-Program-PortfolioMgmt

#631: Bold Leadership: Embolden Your Team for Smart Risk-Taking

#631

Pharma药企

04: MedAffairs-SciComm

#628: Beyond the Keyboard: Elevating Regulatory Writing with a Business Mindset

#628

Pharma药企

04: MedAffairs-SciComm

#634: Access Unlocked: Collaborative Strategies for Navigating Regulatory and Payor Landscapes

#634

Pharma药企

03: Data-Tech-AI

#626: Navigating the Regulatory Labyrinth: How Well Do Language Models Read the Fine Print?

#626

Pharma药企

03: Data-Tech-AI

#651: Regulatory CMC and Product Quality Hot Topics Discussion

#651

Pharma药企

03: Data-Tech-AI

#651: Regulatory CMC and Product Quality Hot Topics Discussion

#651

Pharma药企

03: Data-Tech-AI

#658: Navigating the Rules of Innovation: Regulatory Expectations for Generative AI Use Cases

#658

Pharma药企

03: Data-Tech-AI

#658: Navigating the Rules of Innovation: Regulatory Expectations for Generative AI Use Cases

#658

Pharma药企

03: Data-Tech-AI

#646: Accelerating AI-Enabled Drug Discovery and Development with Federated Computing

#646

Pharma药企

01: ClinSafety-PV-RM

#643: Utilizing Signal Detection Methodologies: A Toolkit for Diverse Product Types

#643

Pharma药企

01: ClinSafety-PV-RM

#653: Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII Across the Product Lifecycle

#653

Pharma药企

03: Data-Tech-AI

#651: Regulatory CMC and Product Quality Hot Topics Discussion

#651

Pharma药企

08: RegPolicy-Strategy-GlobalCollaboration

#655: Navigating the New US and EU Rare Disease Regulatory Framework and Global Harmonization Efforts

#655

Pharma药企

06: ProfDevelop-Program-PortfolioMgmt

#650: Leading for Growth: Unlocking Individual Potential in Your Team

#650

Pharma药企

04: MedAffairs-SciComm

#648: Medical Affairs: Drivers of Scientific Impact and Strategic Value in Healthcare

#648

Pharma药企

01: ClinSafety-PV-RM

#653: Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII Across the Product Lifecycle

#653

Pharma药企

02: ClinicalTrialOps-Innovation

#647: Not Can, but Should: How do we WANT AI/ML to Transform Clinical Development?

#647

Pharma药企

04: MedAffairs-SciComm

#648: Medical Affairs: Drivers of Scientific Impact and Strategic Value in Healthcare

#648

Pharma药企

10: Stats-EvidenceGeneration-RWE

#659: Real World Evidence in Regulatory Decision-Making: Challenges, Innovations, and Impact

#659

Pharma药企

03: Data-Tech-AI

#702: Cross-Functional Agentic End-to-End Dossier Preparation: Where are we Today and Progress Towards Realizing the Vision

#702

Pharma药企

03: Data-Tech-AI

#706: AI-Enabled Structured CMC Submissions: Leveraging Cloud Technology for Enhanced Collaboration and Analysis

#706

Pharma药企

03: Data-Tech-AI

#706: AI-Enabled Structured CMC Submissions: Leveraging Cloud Technology for Enhanced Collaboration and Analysis

#706

Pharma药企

03: Data-Tech-AI

#703: How RA/QA Leaders can Optimize AI and Reduce Risk as Industry Moves from the Wild West to its Inevitable Second Phase - Categorization

#703

Pharma药企

04: MedAffairs-SciComm

#704: The View from the Top: What is the Future of Medical Writing?

#704

Pharma药企

01: ClinSafety-PV-RM

#709: PV Compliance DIY: How to Find and Fix Quality Issues Before They Find You

#709

Pharma药企

02: ClinicalTrialOps-Innovation

#711: Role of External Data in Confirmatory Clinical Trial: Current Landscape and Future Perspectives

#711

Pharma药企

08: RegPolicy-Strategy-GlobalCollaboration

#708: Patient Preference Studies in Clinical Trial Design and Submissions: Enhancing Patient-Centricity with Insights from ICH E22

#708

Pharma药企

03: Data-Tech-AI

#702: Cross-Functional Agentic End-to-End Dossier Preparation: Where are we Today and Progress Towards Realizing the Vision

#702

Pharma药企

04: MedAffairs-SciComm

#704: The View from the Top: What is the Future of Medical Writing?

#704

Pharma药企

08: RegPolicy-Strategy-GlobalCollaboration

#708: Patient Preference Studies in Clinical Trial Design and Submissions: Enhancing Patient-Centricity with Insights from ICH E22

#708

Pharma药企

04: MedAffairs-SciComm

#704: The View from the Top: What is the Future of Medical Writing?

#704

Pharma药企

02: ClinicalTrialOps-Innovation

#711: Role of External Data in Confirmatory Clinical Trial: Current Landscape and Future Perspectives

#711

Pharma药企

02: ClinicalTrialOps-Innovation

#711: Role of External Data in Confirmatory Clinical Trial: Current Landscape and Future Perspectives

#711

Pharma药企

03: Data-Tech-AI

#702: Cross-Functional Agentic End-to-End Dossier Preparation: Where are we Today and Progress Towards Realizing the Vision

#702

Pharma药企

00: Plenary

#713: No More Incremental Change: The Radical Future of Healthcare

#713

Pharma药企

02: ClinicalTrialOps-Innovation

#403: Clinical Operations in Transition: Leadership Perspectives on AI, the Workforce, and the Future of Trial Execution

#403

Pharma药企

06: ProfDevelop-Program-PortfolioMgmt

#409: Evolving Role of the Quality Professional: The Future of Professional Development in the Age of AI

#409

Pharma药企

02: ClinicalTrialOps-Innovation

#436: Aligning Strategy with Execution: Leveraging Integrated Program Plans, Project, Program, and Portfolio Management, and AI to Advance Drug Development

#436

Pharma药企

01: ClinSafety-PV-RM

#430: Responsible use of AI in Pharmacovigilance: Global Perspectives from CIOMS WG XIV

#430

Pharma药企

06: ProfDevelop-Program-PortfolioMgmt

#452: Mentorship Myth Busters: Moving Beyond Misconceptions

#452

Pharma药企

02: ClinicalTrialOps-Innovation

#449: Study Participants Want to Know When AI is Processing Their Medical Data: Perceptions of AI and Operational Implications

#449

Pharma药企

16: InnovationTheaters

#522 IT: Artos, Inc Innovation Theater: AI Isn't About Generating Documents, it's About Generating Data

#522 · IT

Pharma药企

01: ClinSafety-PV-RM

#561: Unlocking Transformative Value: AI and Advanced Analytics in Good Clinical Practice and Good Pharmacovigilance Practice Quality Assurance

#561

Pharma药企

06: ProfDevelop-Program-PortfolioMgmt

#554: Reverse Pitches: How Pharma Actually Buys

#554

Pharma药企

04: MedAffairs-SciComm

#628: Beyond the Keyboard: Elevating Regulatory Writing with a Business Mindset

#628

Pharma药企

05: PersonalizedMed-ComboProd-Diagnostics

#630: Streamlining Regulatory Frameworks for Complex Generic Development: Global Extractables and Leachables Harmonization

#630

Pharma药企

02: ClinicalTrialOps-Innovation

#654: India Town Hall: India’s Evolving Regulatory Landscape - Policy Reforms and Digital Systems Accelerating Innovation

#654

Pharma药企

02: ClinicalTrialOps-Innovation

#645: Clinical Trial Experience Surveys: Sponsor Wide Implementation Across Countries and Therapy Areas

#645

Pharma药企

01: ClinSafety-PV-RM

#709: PV Compliance DIY: How to Find and Fix Quality Issues Before They Find You

#709

Pharma药企

01: ClinSafety-PV-RM

#700: Insights Regarding Implementation of the ASAP Process

#700

Pharma药企

01: ClinSafety-PV-RM

#700: Insights Regarding Implementation of the ASAP Process

#700

Pharma药企

02: ClinicalTrialOps-Innovation

#654: India Town Hall: India’s Evolving Regulatory Landscape - Policy Reforms and Digital Systems Accelerating Innovation

#654

Pharma药企

01: ClinSafety-PV-RM

#700: Insights Regarding Implementation of the ASAP Process

#700

CROCRO

16: InnovationTheaters

#401.3 IT: IQVIA Innovation Theater: Transforming Clinical Development - Harnessing AI for Predictive Simulation and Agentic Automation

#401.3 · IT

CROCRO

16: InnovationTheaters

#401.1 IT: Box Innovation Theater: From Digital Debt to Strategic Asset - Making Regulated Clinical Content AI-Ready

#401.1 · IT

CROCRO

16: InnovationTheaters

#425 IT: Parexel Innovation Theater: The Connected Submission - How AI, Automation, and Intelligence are Changing the Regulatory Ecosystem

#425 · IT

CROCRO

10: Stats-EvidenceGeneration-RWE

#459: Bias and Methodological Challenges in External Control Arms Addressing Time-Related Bias, Endpoint Alignment, Unmeasured Confounding

#459

CROCRO

16: InnovationTheaters

#502 IT: IQVIA Innovation Theater: From Insight to Impact - Leveraging Patient Experience Data Through Technology and AI

#502 · IT

CROCRO

16: InnovationTheaters

#503 IT: Parexel Innovation Theater: Human-Centered AI - A Dual-Layer Model for Clinical Research Excellence

#503 · IT

CROCRO

02: ClinicalTrialOps-Innovation

#519: Patient Registries: Basket Trial or Basket Case?

#519

CROCRO

02: ClinicalTrialOps-Innovation

#515: Leveraging Federated AI and Open Data to Transform Oncology Research and Development

#515

CROCRO

16: InnovationTheaters

#523 IT: Syneos Health Innovation Theater: More Doesn't Guarantee Better - Why AI Success Depends on Organizational Agility, Not Just the Tech

#523 · IT

CROCRO

03: Data-Tech-AI

#625: Building AI Governance Frameworks: Classification, Validation and Regulatory Alignment in Life Sciences

#625

CROCRO

09: RD-Quality-Compliance

#637: Destigmatizing 483 Observations

#637

CROCRO

09: RD-Quality-Compliance

#637: Destigmatizing 483 Observations

#637

CROCRO

02: ClinicalTrialOps-Innovation

#647: Not Can, but Should: How do we WANT AI/ML to Transform Clinical Development?

#647

CROCRO

01: ClinSafety-PV-RM

#701: No Report Left Behind: Human-Centered Safety Reporting

#701