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00: Plenary
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01: ClinSafety-PV
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Forum
Session
Tutorial
02: ClinTrials -ClinOps
All
Forum
Session
Tutorial
Workshop
03: Data-Tech in Clinical Trials
All
Forum
Session
Workshop
04: MedAffairs-SciComm
All
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Session
Workshop
05: Patient Engagement
All
Forum
Session
Workshop
06: PreClinical Dev-EarlyPhaseCR
All
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Session
Workshop
07: ProjectManagement-StrategicPlanning
All
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Session
Workshop
08: RD Quality-Compliance
All
Forum
Session
Tutorial
09: Regulatory
All
Forum
Session
Tutorial
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
13: ProfDevelopment
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Session
Workshop
14: DIAmond
All
Forum
15: Content Hubs
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16: Community Rounds
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17: Networking Opportunities
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18: Posters
All
Poster Presentation
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
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Student Programming
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Monday
, June 13
Virtual
10:00am •
11A: “Has it Happened Already?” Questions of Precedent from Which Regulatory Intelligence Can Save You
2:00pm •
12P: Defining the Clinical Questions of Interest: Why Everyone Developing a Protocol Should Understand Estimands!
Tuesday
, June 14
Virtual
10:00am •
21A: Talking Statistics: Interpreting Statistical Results for Non-Statisticians Involved in Clinical Trials
2:00pm •
22P: Machine Learning in Pharmacovigilance
2:00pm •
23P: Real-World Evidence: The Evolving Landscape of Regulators, Data, and Integrated Use
Wednesday
, June 15
Virtual
10:00am •
32A: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks throughout the Drug Development Lifecycle
10:00am •
31A: Global AdPromo: Considerations for Compliance and Success
2:00pm •
33P: Presentation of Safety Risks Throughout the Product Lifecycle Framework: Key Findings and Practical Uses
Thursday
, June 16
Virtual
8:00am •
41A: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development
2:00pm •
42P: Become a DCT Master: Understanding the Lifecycle of Decentralized Clinical Trials
Monday
, June 20
Exhibit Hall
11:30am •
Luncheon Service
2:15pm •
Refreshment Break
5:00pm •
DIA Welcome Reception supported by Change Healthcare
Exhibit Hall Booth #1719
2:30pm •
Annual Meeting of Members
Exhibit Hall Theater #1
11:50am •
#102 IT: Syneos Health Innovation Theater: Leveraging the Power of Medical Affairs - Overcoming Obstacles to Optimize Product Development
12:35pm •
#106 IT: IQVIA Innovation Theater: Redefining Patient Centricity in a Post-Pandemic Era
2:40pm •
#125 IT: PPD, part of Thermo Fisher Scientific Innovation Theater: Patients as Influencers - How Today’s Patients are Shaping Tomorrow’s Clinical Trial Designs
3:20pm •
#129 IT: Precision for Medicine Innovation Theater: Solving the Unique Central Lab Services Challenges of Precision, Biomarker-Driven Trials
5:15pm •
#147 IT: Care Access Innovation Theater: The DRO Model for Global Clinical Trials: A Demonstrated Transformation that Delivers Game-Changing Speed, Quality, and Access
Exhibit Hall Theater #2
11:50am •
#101 IT: Advanced Clinical Innovation Theater: Implementing Innovative Patient and Site Engagement Strategies for More Predictable Outcomes
12:35pm •
#105 IT: CRIO Innovation Theater: Creating an EMR to EDC Pipeline Through eSource
2:40pm •
#126 IT: Medable Innovation Theater: The Real R&D Accelerator
3:20pm •
#130 IT: Deloitte Innovation Theater: Sanofi’s Approach to Automating Adverse Event Case Processing Through Machine Learning and Innovation
5:15pm •
#148 IT: Parexel Innovation Theater: An Ethical Framework to Guide the Development of AI in Clinical Research
Exhibit Hall Theater #3
11:50am •
#103 IT: Microsoft Innovation Theater: Accelerating Clinical Research - How a New Collaboration is Driving Digital Data Flow Solutions from Protocol Design to Electronic Data Capture
12:35pm •
#107 IT: SAS Innovation Theater: Level Up! Advancing Clinical Trial Operations with Novel Methods and Richer Data
2:40pm •
#127 IT: RWS Innovation Theater: Advancement Through Adversity - How COVID-Driven Innovations are Becoming Best Practices for Pharmacovigilance
3:20pm •
#128 IT: Castor Innovation Theater: A New Paradigm in CDMS
5:15pm •
#146 IT: Labcorp Innovation Theater: How AI Modeling of Diagnostic Data is Providing Actionable Insights for Difficult to Diagnose Conditions
Level 3 F2 Entrance
12:00pm •
#01 POS : Poster Session I
Room 175
1:15pm •
#108: Support of IND Safety Reporting by the Aggregate Safety Assessment Plan (ASAP)
4:00pm •
#132: ICH E2D Update: Innovations in Collecting Safety Data from Disparate Sources
Room 176
1:15pm •
#109: Risk-Based Monitoring in Clinical Trials: An Evolution of Practices During the COVID Pandemic
4:00pm •
#133: New Tools for Creating Flexible and Sustainable Master Protocols
Room 178
1:15pm •
#110: Adaptive Designs Save Time and Money: Regulatory Agencies Accept Them - Why Aren’t They Used More?
4:00pm •
#134: FDA Update on the Upcoming PDUFA VII Data and Technology Commitment
Room 179
1:15pm •
#111: The Role of Sensors in Clinical Research: Integrating Sensor Generated Data into Data Platforms to Power Clinical Research and Patient Care
4:00pm •
#136: Developing and Implementing a Strategic Framework to Guide Patient Engagement
Room 180
1:15pm •
#112: ICH Q2 (R2) and Q14: Can We Realize the Vision for Risk-Based Approvals of Analytical Procedures and Changes?
4:00pm •
#142: The Future of CMC Regulatory Submissions: Streamlining Activities Using Structured Content and Data Management
Room 183 A
1:30pm •
#116: Incorporating Patient Experience Data in Global R&D
Room 183 B
1:30pm •
#114: Data Integrity Across the Product Lifecycle
4:00pm •
#143: A Targeted Learning Framework for Causal Effect Estimation Using Real-World Data
Room 183 C
1:30pm •
#117: The Translational Value of Animal Models in Rare Diseases
4:00pm •
#144: Value of Patient Experience Data in Healthcare Decision-Making
Room 184
1:30pm •
#118: Real-World Evidence Frameworks Across the World: Three International Perspectives
4:00pm •
#140: ICMRA: COVID-19 Response and International Collaboration
Room 185 AB
1:30pm •
#120: Practical Applications of the Estimand Framework in Novel, Complex Settings
4:00pm •
#138: ICH E8(R1): Regulators' Perspectives on Quality-by-Design of Clinical Studies
Room 185 CD
1:30pm •
#121: Identifying Value and Driving Access to Drug-Based Products Evaluated Using Digital Endpoints
4:00pm •
#131: Innovations for Implementing REMS
Room 186
1:30pm •
#115: Scientific Communication During a Pandemic: The Ethics of Ensuring Accuracy and Combatting Misinformation
4:00pm •
#137: Successful Virtual Partnering
Room 187
1:30pm •
#119: Is it Time to Change the Accelerated Approval Pathway?
4:00pm •
#139: FDA and EMA Benefit-Risk Assessments: Can We Optimize and Is There an Enhanced Role for Sponsors and Patient Preferences?
Room 375 A Zone 1
2:30pm •
#124 RT: Round Table Discussion: Support of IND Safety Reporting by the Aggregate Safety Assessment Plan (ASAP)
Room 470 A
9:00am •
Annual Meeting Orientation
1:15pm •
#113: Fostering Innovation and Psychological Safety
2:30pm •
#122 CH: Transgender and Non-Binary Patients’ Inclusivity in Clinical Research: How Far Have We Come and Where Are We Going Next?
4:00pm •
#145: Design Thinking: The Empathy Map
Room 470 B
12:15pm •
#104 CH: What Do Patients Want From Digital Solutions? Considerations for Access, Self Determination of Their Data and Portability
2:30pm •
#123 CH: Mastering the Science of Medical Writing Communications
4:00pm •
#135: Demystifying the Delivery of Healthcare Economic Information (HCEI) by Medical Affairs and Market Access Personnel
Room 471 A
3:00pm •
#002 STU: Collective Connections: Networking with Leaders
4:00pm •
DIA Student Case Competition Presentation
Room Skyline 375 CDE
10:00am •
#100: Opening Plenary: The Future of Healthcare
Skyline Ballroom Foyer
8:00am •
Coffee Service
Tuesday
, June 21
Exh Hall Community Area
12:00pm •
Community Networking Lunch
Exhibit Hall
10:00am •
Coffee Break
12:00pm •
Luncheon Service
2:45pm •
Refreshment Break
Exhibit Hall Theater #1
10:20am •
#217 IT: Flatiron Health Innovation Theater: Leveraging Access at the Point of Care and Next-Generation Electronic Source (eSource) Technology to Accelerate Clinical Research
12:25pm •
#235 IT: Veeva Innovation Theater: Clinical Trials Prepare for a Digital, Connected Future
1:05pm •
#238 IT: Precision for Medicine Innovation Theater: Bridging Clinical Operations and Translational Science to Meet Critical Endpoints in Precision Medicine Trials
3:10pm •
#259 IT: UBC Innovation Theater: Modernizing Observational Research and Decentralized Studies with Patient Mediated Electronic Medical Record Release
3:50pm •
#263 IT: Certara Innovation Theater: Optimizing Patient Narrative Technology - Automating the Complicated and Creating Efficiency
Exhibit Hall Theater #2
10:20am •
#216 IT: Clario Innovation Theater: Decentralized Clinical Trials - Real Solutions in Real-Time
12:25pm •
#233 IT: JMP Statistical Discovery Innovation Theater: Interactive Safety Assessment Reports to Aggregate, Filter, and Subgroup Clinical Trial Data
1:05pm •
#239 IT: IQVIA Innovation Theater: Delivering Better Outcomes with Connected Intelligence
3:10pm •
#258 IT: IBM Watson Health Innovation Theater: User Centricity in Clinical Data Management - The Next Revolution for eClinical Solutions
3:50pm •
#264 IT: Veeva Innovation Theater: Defining Digital Trials to Operationalize Decentralized Trials
Exhibit Hall Theater #3
10:20am •
#218 IT: Twilio for Life Sciences Innovation Theater: Delivering Personalized Experiences through Omnichannel Engagement
12:25pm •
#234 IT: Labcorp Innovation Theater: The Labcorp Patient Recruitment Ecosystem - Designing a Better Clinical Trial Experience
1:05pm •
#240 IT: Microsoft Innovation Theater: The New Reality of Work in Pharma - How Mixed Reality is Modernizing Operations, Accelerating Research and Improving Patient Engagement
3:10pm •
#260 IT : Appian Innovation Theater: Shape the clinical trials journey by bringing people, process and data together on a unified platform
3:50pm •
#265 IT: M-Files Innovation Theater: Does your Document Management System Support your Growth Trajectory? A Charles River Labs Story
Level 3 F2 Entrance
12:00pm •
#02 POS: Poster Session II
Meeting Rm Lobby Level 1
8:00am •
Coffee Service
Room 175
9:00am •
#201: Transforming PV at the MHRA
11:00am •
#223: Meeting Regulatory Expectations: What Needs to be Considered When Using Digital Technologies to Generate Clinical Evidence?
1:45pm •
#242: Risk Minimization for Health Products: What are we Learning for an Improved Path Forward
4:15pm •
#267: Improving Safety Data Through Innovative Use of Technology
Room 176
9:00am •
#202: Innovations in Risk Minimization: Methods, Tools, and Design Approaches
11:00am •
#219: Post-Approval Safety Studies: Approaches to Assessing Medication Exposure and Potential Safety Risks During Pregnancy
1:45pm •
#243: Technology-Enabled Clinical Trials Using Electronic Health Record (EHR)-Derived Real-World Data: Opportunities and Limitations
4:15pm •
#276: Rethinking Fundamental ICH CMC Guidelines: Analytical Procedures, Stability, Specifications, and Risk Assessment
Room 178
9:00am •
#203: The Site Landscape: Data and Discussion of the State of the Clinical Research Site
11:00am •
#225: Solving for ‘Shared Value’ of Cell and Gene Therapy with Real-World Evidence in the Post-Pandemic Healthcare Ecosystem
1:45pm •
#241: Drug Safety in Africa: New PV Horizons
4:15pm •
#266: FDA's Updates on Ensuring Post Market Safety and Surveillance for Generic Drugs
Room 179
9:00am •
#204: Diversity and Inclusion in Clinical Trials: Concrete Strategies for Enhancing Health Equity
11:00am •
#224: ICMRA Update: Convergence and Collaboration on COVID-19 - Learning from the Present for the Future
1:45pm •
#244: Planning and Conducting Efficient, High-Quality Decentralized Trials: A Multi-Stakeholder Initiative
4:15pm •
#274: Regulatory Convergence Successes and Opportunities
Room 180
9:00am •
#205: Optimizing Evidence Supporting Fit-for-Purpose Digital Clinical Measures Across the Drug Development Life Cycle
11:00am •
#220: Collection of Quality Endpoint Data in a Decentralized Trial in Complex Indications: The Practical and Logistical Challenges
1:45pm •
#245: Understanding the Consumer's Journey for Information From Searching for Information to Using Information
4:15pm •
#270: Recommendations for Conducting Bring Your Own “Device” (BYOD) Clinical Studies
Room 183 A
9:15am •
#215: Efforts Toward Global Convergence of CMC and GMP Expectations
11:00am •
#222: Patient-Focused Drug Development: Reflecting on a Decade of Insights
2:00pm •
#249: Regulatory-Grade Real-World Evidence: Distilling to Practice
4:15pm •
#268: Life Science Research Innovation Powered by Real-World Data
Room 183 B
9:15am •
#210: Challenges of Translational and Early-Phase ASO Development
11:15am •
#228: Individualized Therapeutics: Walking the Line Between Research and Treatment
2:00pm •
#251: Data Science, Text Analytics, and Machine Learning to Derive Insights from Clinical Quality, Compliance, and Real-World Data
4:15pm •
#275.1: PMDA Town Hall
Room 183 C
9:00am •
#207: Enhancing Interactions Among Stakeholders to Advance Patient-Focused Drug Development: Landscape of Current Activities
11:15am •
#227: Approaching the Assessment of Clinical Protocol Complexity
2:00pm •
#250: Patients as Central Partners in COA Design
4:15pm •
#269: Strategic Planning in Selecting the Right Countries and Sites for Clinical Trials
Room 184
9:15am •
#209: New EU Clinical Trial Regulation: Experience So Far
11:15am •
#232: Preparing for the Future of Research and Development:10-Years of Multistakeholder Innovation, Collaboration, and Transformation
2:00pm •
#252: International Collaborations: What’s New in Oncology?
4:15pm •
#271: Building the First Cloud-Based Submission Review Collaboration Platform
Room 185 AB
9:15am •
#212: Where Are We with Antimicrobial Resistance (AMR) in the Regulatory Space?
11:15am •
#229: Accelerating Cell and Gene Therapy Development Through International Regulator Collaboration
2:00pm •
#253: Efforts to Improve Diversity of Clinical Trial Participants
4:15pm •
#277: Quantitative Benefit-Risk Approaches in Drug Development and Approval: Examples from FDA and Industry
Room 185 CD
9:15am •
#214: New Policy Developments in Combination Products
11:15am •
#226: Simulating Trial Activities with Patients: Our Experiences
1:45pm •
#247: Paying for Digital Health: What Evidence is Needed?
4:15pm •
#275: How to Interact with Regulators to Qualify a Digital Mobility Outcome?
Room 186
9:15am •
#211: Shifting the Audit Paradigm for a More Effective Outcome
11:15am •
#230: Asia Town Hall
2:00pm •
#248: Healthcare Datasets as Assets: Secure and Compliant Valuation and Transaction Methods
4:15pm •
#272: Fit-for-Purpose Patient Preference Studies: Emerging Recommendations from IMI PREFER
Room 187
9:15am •
#213: Reflections on PDUFA: A Look Back at PDUFA VI and A Preview of PDUFA VII
11:15am •
#231: Leveraging Real-World Evidence for Regulatory Purposes
2:00pm •
#254: Overcoming Challenges in Pediatric Product Development
4:15pm •
#278: FDA Real-World Evidence Guidance for Regulatory Approval: Implications for Evidence Needs for Payers and Population-Based Decision Makers and Healthcare Providers
Room 375 A Zone 1
12:30pm •
#236 RT: Round Table Discussion: FDA Update on the Upcoming PDUFA VII Data and Technology Commitment
3:00pm •
#256 RT: Round Table Discussion: Technology-Enabled Clinical Trials Using Electronic Health Record (EHR)-Derived Real-World Data: Opportunities and Limitations
Room 375 A Zone 2
12:30pm •
#237 RT : Round Table Discussion: Individualized Therapeutics: Walking the Line Between Research and Treatment
3:00pm •
#257 RT: Round Table Discussion: Enhancing Interactions Among Stakeholders to Advance Patient-Focused Drug Development: Landscape of Current Activities
Room 470 A
9:00am •
#208: Keeping Passion for Project Management Alive
12:45pm •
#237.2 CH: Location, Location, Location: Building the Next Generation of Community-Based Clinical Trial Site Networks
2:00pm •
#255: Demystifying Statistical Concepts for Non-Statisticians Involved with Clinical Trials
3:30pm •
#261 CH: How Drug Development Will Change Post-COVID
4:15pm •
#279: Decision Making and Decision Science;: Learn to Make Better Business and Life Decisions from Patients that Used Decision Science
Room 470 B
9:00am •
#206: The Future of Content Authoring and Web Portal Technology, Publishing Stability Calculators: Challenges for Pushing Automation
11:00am •
#221: Complying with the EU-CTR Disclosure Standards in the Era of GDPR
12:45pm •
#237.1 CH: Emerging Editorial Policies, Researcher, and Author Standards in Promoting Diversity, Inclusion, and Equity in Cancer Research
1:45pm •
#246: Project Management Across the Healthcare Continuum
3:30pm •
#262 CH: Mentoring 101
4:15pm •
#273: IMPALA (IntercoMPany quALity Analytics) Industry Group: Data Science Development and Other Collaboration Updates
Room 471 A
12:45pm •
#003 STU: Career Ladder or Career Lattice? Strategies for Career Development
4:15pm •
Poster Showcase Session
5:00pm •
DIA Publications Meet and Greet: Overview and Opportunities
Wednesday
, June 22
Exhibit Hall
10:00am •
Coffee Break
12:00pm •
Luncheon Service
2:45pm •
Refreshment Break
Exhibit Hall Theater #1
10:20am •
#314 IT: Datacubed Health Innovation Theater: How Innovations in ePRO Are Powering Better Patient Engagement
12:25pm •
#331 IT: IQVIA Innovation Theater: Real World Evidence (RWE) to Enhance Clinical Development
1:05pm •
#339 IT: Parexel Innovation Theater: FSP Futureview - Building Infrastructure and Talent for a Flexible Future
3:10pm •
#358 IT: Axiom Innovation Theater: Saving Patient Lives – The Value of Time
3:50pm •
#362 IT: PointClickCare Innovation Theater: LTPAC EHR Data - Patients Included!
Exhibit Hall Theater #2
10:20am •
#315 IT: RxTROSPECT Innovation Theater: Oncology - Expediting Strategy
12:25pm •
#332 IT: Deloitte Innovation Theater: Ushering in Next-Gen Regulatory Intelligence
1:05pm •
#338 IT: Evernorth Innovation Theater: Trends in Behavioral Health - Effects of Telehealth, Medications, and Outpatient Treatment on Total Cost of Care
3:10pm •
#359 IT: Calyx Innovation Theater: Meeting Regulatory Expectations on IRT Data Ownership
3:50pm •
#364 IT: Florence Healthcare Innovation Theater: Design Better Trials with Always-On Connectivity to Sites - A Case Study
Exhibit Hall Theater #3
10:20am •
#316 IT: ATCOR Medical Innovation Theater: Non-Invasive Central BP Monitoring - Improving Efficiency and Success of Drug Development
12:25pm •
#333 IT: Curebase Innovation Theater: Learning by Doing - An Analysis of a Curebase DCT Patient Experience
1:05pm •
#337 IT: Yseop Innovation Theater: Automate Medical Writing with Artificial Intelligence (AI)
3:10pm •
#357 IT: Labcorp Innovation Theater: Transforming the Patient Experience in Decentralized Clinical Trials
3:50pm •
#363 IT: ZS Innovation Theater: Shaping the Future of Clinical Development - A Novel Approach for Today’s Siloed Model
Meeting Rm Lobby Level 1
8:00am •
Coffee Service
Room 175
9:00am •
#305: What’s New at ICH? From the E11A Pediatric Extrapolation Guideline to Model Informed Drug Development (MIDD)
11:00am •
#317: Let’s Make a PV Agreement: Four Solutions You Can Use to Enhance Your Entire PVA Process
1:45pm •
#341: New Approaches to Site Selection in Clinical Trials
4:15pm •
#365: Field of Dreams: If We Build it, Will they Come? Using Implementation Science to Improve Digital Risk-Minimization Tools
Room 176
9:00am •
#302: Mission-Driven Research Partners: How Patient Advocacy Organizations Can Help Advance Your Therapeutic R&D Programs
11:00am •
#320: De-Risking Decentralized: Understanding the Dimensions of Risk and Maximizing Data Quality in Decentralized Trials
1:45pm •
#342: Democratizing Data for Cancer Research and Real-World Evidence Generation
4:15pm •
#367: Local Conduct for Global Clinical Trials: Focus on Japan, Latin America, and Africa
Room 178
9:00am •
#301: Uses of Artificial Intelligence for PV in the Context of COVID 19
11:00am •
#318: Rare Disease Data Sharing: A Value Proposition
1:45pm •
#340: Monitoring COVID-19 Vaccine Safety
4:15pm •
#366: Development of Standard Core Sets of Clinical Outcome Assessments and Related Endpoints
Room 179
11:00am •
#319: Ensuring Diversity in Clinical Trials
1:45pm •
#343: Redefining the Value Proposition for Innovation: Connecting Data, Technology, and Quality to Improve Outcomes
4:15pm •
#378: US Health Care System Adoption of a Class of New Technologies for the Treatment of Alzheimer’s Disease: Access Challenges and Opportunities
Room 180
9:00am •
#307: Improve the Speed and Cost of Clinical Trials With Bayesian Approaches: Unpacked for Non-Statisticians
11:00am •
#321: FHIR in Clinical Research
1:45pm •
#345: Statistical Issues in Master Protocols: Beyond Type I Error and Concurrent Controls
4:15pm •
#371: Reimbursement, Compensation, and Incentives: Best Practices for Payments to Research Participants
Room 183 A
11:15am •
#325: Assessing and Integrating Patient Preferences into Treatment and Clinical Trial Design
2:00pm •
#351: Health Canada Town Hall
4:15pm •
#368: Sneak Peak: First Share from Initiatives of a Global Collaboration to Address Barriers to Decentralized Trial Scale and Adoption
Room 183 B
9:15am •
#308: Community and Patient Engagement: Putting Research into Context
11:15am •
#328: Approaches to Health Authority Collaboration: Are They Fit-for-Purpose and How Should They Evolve Post-Pandemic?
2:00pm •
#353: Planning for the Worst: Approaches for Drug Shortage Avoidance
4:15pm •
#373: Effective Oversight Strategies of CROs and Digital Technology Vendors: How to Comply with Health Authority Expectations
Room 183 C
9:00am •
#306: Leveraging Best Practices and Tools from the Discipline of Project Management to Uphold Quality, Protect Patient Safety, and Optimize Financial Budgets in a World of Complexities
11:15am •
#324: The Value of Medical Writing: The Regulator's Perspective, Development of Professional Medical Writers as Successful Leaders
2:00pm •
#354: How Can Population Decisions Makers and Pharmaceutical Companies Engage Collaborative Research?
4:15pm •
#376: How to Manage Device Design Changes Under EU MDR
Room 184
9:15am •
#312: COVID-19 360°: Embedding Global Best Practices in Routine Regulatory Action and Preparing for the Next Pandemic
11:15am •
#330: Leveraging Real-World Evidence to Address Diversity Gaps in Randomized Clinical Trials: Regulatory, Clinical, and Other Considerations
2:00pm •
#347: Enabling Digital Transformation in Health Care and Clinical Trials
4:15pm •
#374: Around the World: Regulator Perspectives on Decentralized Clinical Trials
Room 185 AB
9:15am •
#310: BsUFA III and GDUFA III: Increasing FDA’s Authority to Enhance Competition
11:15am •
#327: New Approaches to Inspections
2:00pm •
#348: Research and Innovation to Enhance Patient Access to Topical Dermatological Products in the US
4:15pm •
#370: Where Are we Really on Data Interoperability?
Room 185 CD
9:15am •
#311: Ahead of Analyses: Planning, Designing, and Pre-Specifying Observational Studies
11:15am •
#329: Complex Innovative Design: What’s in Name? A Global Perspective on the Changing Design Landscape
2:00pm •
#350: The Transformation of Quality Assurance: The Roadmap
4:15pm •
#369: Approaches to Addressing Diversity and Inclusion in Clinical Research
Room 186
9:15am •
#313: China Town Hall
11:00am •
#323: Remote GMP Assessments, Inspections and Audits : Here to Stay?
2:00pm •
#349: The Power and Uncertainty of Data: How it Can be Used to Drive Efficiency While Recognizing its Limitations
4:15pm •
#372: Accelerating Innovation Through Investing
Room 187
9:15am •
#309: Pharmacovigilance Quality: Key Considerations
11:15am •
#326: China’s Biopharma Innovation Landscape and Trends
2:00pm •
#352: FDA Rare Disease Town Hall
4:15pm •
#375: The Global Impact of ORBIS: Case Studies and Perspectives
Room 375 A Zone 1
12:30pm •
#334 RT: Round Table Discussion: The Value of Medical Writing: The Regulator's Perspective, Development of Professional Medical Writers as Successful Leaders
3:00pm •
#355 RT: Round Table Discussion: Mission-Driven Research Partners: How Patient Advocacy Organizations Can Help Advance Your Therapeutic R&D Programs
Room 375 A Zone 2
12:30pm •
#335 RT: Round Table Discussion: Value of Patient Experience Data in Healthcare Decision-Making
3:00pm •
#356 RT: Round Table Discussion: Planning for the Worst: Approaches for Drug Shortage Avoidance
Room 470 A
9:00am •
#303: Grappling with Uncertainty: Pediatric Gene Therapy Trials and Ethics
11:00am •
#322: Risky Business – The Sequel: Successfully Manage Program-Level Risk
1:45pm •
#344: Managing Up and Managing Down: Developing and Advocating for Your Medical Writing Team
3:15pm •
#360 CH: Considerations for Establishing Meaningful Change for Digital Endpoints Derived From DHT Drug Development Tools
4:15pm •
#379: Search Within: Maximize your Strengths and Possibilities
Room 470 B
9:00am •
#304: Transformation of the Data Manager to the Data Scientist
12:45pm •
#336 CH: Reviewing FDA's Draft Guidance on PROs in Oncology Trials: How This Affects Future Measurement Strategy and Study Designs
1:45pm •
#346: New Global Team: Building and Leading Remote Teams and Non-Fulltime Equivalents (FTEs)
3:15pm •
#361 CH: Separating the AI Hype From Reality: A Primer on NLP (Natural Language Processing)
4:15pm •
#377: Choosing the Most Convincing Clinical Endpoints in Cancer Clinical Trials: How to Balance Different Perspectives?
Room 471 A
12:45pm •
#005 STU: Hashtag Your Way to a Job: How to Use Social Media to Promote Yourself and Start Your Career
Thursday
, June 23
Meeting Rm Lobby Level 1
8:00am •
Coffee Service
Meeting Room Lobby
11:00am •
Coffee Break
Room 175
10:00am •
#404: Combination Product Safety: A Journey of Organizational Transformation
Room 176
10:00am •
#405: How the Heck do I Get this Digital Endpoint to Work in my Clinical Trial? Nuts and Bolts for Trials Teams
Room 178
10:00am •
#406: The PCORnet Response to COVID-19: The Importance of Partnerships, Data, and Digital Innovations to Provide Fast Answers
Room 179
10:00am •
#407: Methodologies Used to Aggregate Real-World Data and Clinical Trial Data
Room 180
10:00am •
#408: Writing at Lightspeed: Optimizing Submission Dossiers in Today’s Environment Through Better Processes, Planning, and Technology
Room 183 A
10:00am •
#411: FDA Oncology Center of Excellence’s Real-Time Oncology Review Program: 2022 Update
Room 183 C
10:00am •
#413: Where Next? Targeting Value Assessment and Contracting Optimizing Adoption, Use, and Payment for Technologies and Therapies in Care
Room 184
10:00am •
#415: EMA-FDA Question Time
11:30am •
#416: FDA Town Hall
Room 185 AB
10:00am •
#409: How to Build and Support a Culture that Values Critical Thinking and Open, Proactive Dialogue About Quality
Room 185 CD
10:00am •
#412: Novel Visualization Tools for Safety Assessment: An Initiative Based on Multidisciplinary Collaboration
Room 187
10:00am •
#410: Addressing Gaps in the Use of Real-World Evidence for Regulatory Decision-Making
Room 375 A Zone 1
9:00am •
#402 RT: Round Table Discussion: Reimbursement, Compensation, and Incentives: Best Practices for Payments to Research Participants
Room 470 A
9:15am •
#403 CH: Who Should Be in the Room to Discuss Risk-Based Quality Management (RBQM) for a Clinical Trial Protocol?
Room 470 B
10:00am •
#414: Optimizing the Pharma Workforce for Trial Success in the Digital Era
Room 471 A
9:00am •
#007 STU: It’s About the Journey Not the Destination: Lessons Learned in Professional Development
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