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00: Plenary
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01 - Clinical Safety and Pharmacovigilance
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01: ClinSafety-PV
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02: ClinTrials -ClinOps
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03: Data-Tech in Clinical Trials
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04: MedAffairs-SciComm
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05: Patient Engagement
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06: PreClinical Dev-EarlyPhaseCR
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06 - Translational Sciences and Precision Medicine
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06: TranslationalScience-PrecisionMedicine
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07: ProjectManagement-StrategicPlanning
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08: RD Quality-Compliance
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09: Regulatory
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10: RegCMC-Product Quality
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11: Statistics
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12: Value-Access
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13: ProfDevelopment
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14: DIAmond
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15: Content Hubs
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16: Community Rounds
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17: Networking Opportunities
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18: Posters
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19: InnovationTheaters
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20: Short Courses
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Featured Topics
AI and Machine Learning
COVID-19
Data Science
Decentralized Trials
Digital
Diversity Equity and Inclusion
Innovative Trial Design
Patient Perspective
Personalized Health Care
Regulator Perspective
Remote Work
RWD-RWE
Special Populations
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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
Timezone
Africa/Abidjan
Africa/Accra
Africa/Addis Ababa
Africa/Algiers
Africa/Asmara
Africa/Bamako
Africa/Bangui
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Africa/Bissau
Africa/Blantyre
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Africa/Cairo
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Africa/El Aaiun
Africa/Freetown
Africa/Gaborone
Africa/Harare
Africa/Johannesburg
Africa/Juba
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Africa/Khartoum
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Africa/Maputo
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Africa/Ndjamena
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Africa/Nouakchott
Africa/Ouagadougou
Africa/Porto-Novo
Africa/Sao Tome
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Africa/Windhoek
America/Adak
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Australia/Adelaide
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Australia/Eucla
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Europe/Amsterdam
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Monday
, June 13
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, June 14
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, June 15
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, June 16
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, June 20
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, June 21
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, June 22
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, June 23
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, June 12
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, June 13
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, June 14
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, June 26
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, June 27
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, June 28
Thursday
, June 29
Venue
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
Session Type
00: Plenary
All
Forum
01 - Clinical Safety and Pharmacovigilance
All
Tutorial
01: ClinSafety-PV
All
Forum
Session
Tutorial
Workshop
02: ClinTrials -ClinOps
All
Forum
Session
Tutorial
Workshop
03: Data-Tech in Clinical Trials
All
Forum
Session
Workshop
04: MedAffairs-SciComm
All
Forum
Session
Workshop
05: Patient Engagement
All
Forum
Session
Workshop
06: PreClinical Dev-EarlyPhaseCR
All
Forum
Session
Workshop
06 - Translational Sciences and Precision Medicine
All
Tutorial
06: TranslationalScience-PrecisionMedicine
All
Forum
Session
07: ProjectManagement-StrategicPlanning
All
Forum
Session
Workshop
08: RD Quality-Compliance
All
Forum
Session
Tutorial
Workshop
09: Regulatory
All
Forum
Session
Tutorial
Workshop
10: RegCMC-Product Quality
All
Forum
Session
11: Statistics
All
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Session
Tutorial
Workshop
12: Value-Access
All
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Session
Workshop
13: ProfDevelopment
All
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Session
Workshop
14: DIAmond
All
Forum
15: Content Hubs
All
Workshop
16: Community Rounds
All
Session
17: Networking Opportunities
All
Forum
Session
Social Event
18: Posters
All
Poster Presentation
19: InnovationTheaters
All
Session
20: Short Courses
All
Tutorial
Other Filters
Level
Advanced
Basic
Intermediate
Featured Topics
AI and Machine Learning
COVID-19
Data Science
Decentralized Trials
Digital
Diversity Equity and Inclusion
Innovative Trial Design
Patient Perspective
Personalized Health Care
Regulator Perspective
Remote Work
RWD-RWE
Special Populations
Student Programming