Loading…
Simple
Expanded
Grid
By Venue
Level: Intermediate [clear filter]
Monday, June 26
 

9:00am EDT

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

10:45am EDT

#101: Artificial Intelligence: Delivering on the Promise Room 205 BC #103: Sponsor-CRO Collaborations and the Impact of Decentralized Clinical Trials Room 253 A #102: Risk-Based Monitoring in Clinical Trials: A Four-Year Analysis Room 254 #110: Disruptive Medicine Innovation: Combination Products Room 153 AB #114: Navigating the Constellation of Efforts to Increase Representation in Clinical Research Room 210 #104: Inspired by Big-Tech and Humbled by Complexity of Clinical Research: Clinical Trial Digital Transformation Room 206 #112: Applying Implementation Science Methods to Generate Evidence to Improve Access to New Therapeutics: What has Been Learned? Room 104 AB #111: E9(R1) Implementation: Practical Applications of Using Estimands in Protocols, SAPs, Data Standards and Examples of use of Estimands Room 102 #105: What’s in the Future for Global Advancements in Patient Engagement and Patient-Focused Medical Product Development? Room 205 A #106: New Alternative Methods-Only IND/CTA Application: Distant Dream or Immediate Possibility? Room 253 C #109: Cell and Gene Therapies Pulse Check Room 156

12:00pm EDT

#115: Blockchain-Based Technologies for Clinical Research: Distinguishing Myth from Reality Content Hub NE Lobby

1:30pm EDT

#125: Enhancing the Quality of Safety Data Collection Room 205 BC #126: Can We Further Innovate Clinical Trial Designs? Lessons Learned and Future Opportunities Room 206 #127: Patient-Reported Outcome Measures to Support Oncology Clinical Development and Labeling: Responding to FDA’s Draft Guidance Room 254 #138: Advances in Real-World Evidence: Real-World Data Hybrid Randomized Clinical Trials, Publication Scandal, and China’s Real-World Evidence Heaven Room 102 #129: Innovative Digital Health Technologies: Strategies for Successful Integrations, Quality, and Compliance Room 253 A #128: Building Trust: Data Privacy in Decentralized Clinical Trials Room 252 #130: On the Path to Enlightened Conversations: Setting up Structured Content Authoring Room 253 C #131: Beyond the Why: How to Effectively Implement a Patient-Led Approach to Clinical Trial Design and Conduct Room 205 A #132: Contemporary Challenges in Personalized Medicine and Companion Diagnostics Room 253 B #133: Unleashing the Fearless Quality Professional Room 204 #134: Accelerated Approval in Rare Diseases: The Role of Novel Biomarker, Surrogate Endpoints, and Other Innovative Approaches in Expediting Development Room 153 AB #137: International Collaboration for Pharmaceutical Quality and Manufacturing Agility Room 151

4:15pm EDT

#149: Utilizing Wearable Biosensors to Better Manage Patient Safety During Immuno-Oncology Studies Room 205 BC #152: Digital Endpoints in Clinical Trials: Qualifications, Collaborations, and Risk-Based Approaches Room 206 #153: The True Decentralization of Clinical Trials: Benefits and Drawbacks of Blockchain Technology Room 253 A #154: Best Practices in Effective Gathering of Medical Information Industry Insights Room 253 C #156: What's Next in Precision Medicine? Translational Strategies for Dose Optimization in the Age of Project Optimus Room 102 #157: IMPALA (IntercoMPany quALity Analytics) Industry Consortium: Quality Analytics Use Cases and Early Health Authority Feedback Room 253 B #158: Emerging Therapies and Technologies: Leveraging Opportunities for Engaging in Pre-Competitive Research and with Medicine Regulators to Support Innovation Room 153 AB #160: Regulatory Cooperation, Coordination, and Reliance in Times of Crisis: The ICMRA Role Room 104 AB #159: The Promise of Vaccine Platforms to Advance Regulatory Science: Where are we Now, Where are we Going, and How do we get There? Room 156
 
Tuesday, June 27
 

8:30am EDT

#212: Full Exposure: Artificial Intelligence to Advance, Replace, and Add Efficiency for Patient Benefit Room 210 #201: Completing the Risk Management Cycle: Review of Risk Management Effectiveness Room 205 BC #204: ICH M11 Clinical Electronic Structured Harmonized Protocol (CeSHarP): Enabling Consistency and Information Exchange Room 206 #205: The Case for Generating Synthetic Data as Real-World Data: Regulatory and Planning Perspectives  Room 253 A #207: Utilizing Analytics, Visualizations, and Decision Science to Drive Strategic Decision Making Room 204 #136: WHO Town Hall: The New Era of WHO Listed Authorities (WLAs), Reliance in Action, and Country and Regional Focus for Regulatory Systems Strengthening Room 205 A #208: NMPA Town Hall Room 151 #209: International Regulatory Convergence and Collaboration Room 153 AB #210: Pediatrics and the Paradox of Progress: What’s New, What’s Next, What’s Needed? Room 157 AB #211: Office of Generic Drugs/Office of Pharmaceutical Quality Town Hall Room 156

10:30am EDT

#216: Benefit-Risk Balance for Medicinal Products: CIOMS Working Group XII Report Room 205 BC #217: Good Recruitment Practice Under Regulation (EU) No 536/2014 Room 254 #218: The Future of Regulatory Submissions: Opportunities and Challenges Room 206 #224: Time for Alignment? A Policy Landscape Update on the Use and Acceptance of Real-World Data/Real-World Evidence for Regulatory Purposes Room 153 AB #220: Disrupting the Status Quo: Best Practices for Bringing Together Patients and Medical Staff to Positively Impact Trial Diversity Room 205 A #221: The Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP) Collaboratory: Facilitation of Medical Product Development for Rare Diseases Room 252 #227: ANVISA Town Hall Room 253 A #225: Post-Pandemic Regulatory Innovation for Clinical Trials and Opportunities for Global Alignment Room 156 #226: Patient Experience Data in the Label: Closing the Loop Room 157 AB

12:30pm EDT

#238: Simultaneous Writing of Clinical Reports, Summaries, and Overview for Submissions: Is this the New Normal? Content Hub NE Lobby

1:15pm EDT

#242: Novel Methods for Signal Identification for Medicines and Medical Devices Room 205 BC #244: Meta-Collaboration to Improve Decentralized Trial Excellence: Updates from the Collaboration Landscape Room 254 #243: Hot off the Press: Site Challenges and Solutions in Workforce and Technology Room 253 A #245: Global Regulatory Perspectives About Real-World Data: DARWIN EU®, FDA, and Other Current Initiatives Room 206 #253: Quality in the Real World: Identifying and Addressing Inaccuracies and Gaps in Routinely Collected Patient Data Room 102 #246: Tech-Enabled Narratives: Technology Meets Process FTW (For the Win!) Room 253 C #247: Measuring Impact of Patient Engagement Across Research and Development Room 205 A #248: Agile Project Management Practitioners Tackle Challenges Within the Life Sciences Room 204 #255: Future- Proofing your Career: The Essential Guide for all Things Legal and Venture Capital for Biopharma Professionals Room 252 #249: Pharmacovigilance: Regulator's Perspectives on Quality Approaches to Additional Risk-Minimization Measures and Post-Pandemic Inspection Reflections Room 253 B #251: Asia Town Hall Room 153 AB #250: Implementing Digital Health Technologies in Clinical Trials: How to Apply New Resources to Address Key Questions Room 156 #252: One Dossier and One Timeline for a Post Approval Change: The Story of a Regulatory Reliance Pilot! Room 151 #254: The Inflation Reduction Act Price Setting: What are the Impacts on Biopharmaceutical Innovation from Different Perspectives? Room 104 AB

2:30pm EDT

#256: Patients’ Engagement in Drug Development and in Public Private Partnerships Content Hub NE Lobby

3:15pm EDT

#263: RIM Reference Model: An Approach to RIM Data Harmonization and Improving Efficiency, Compliance, and Interoperability Content Hub NE Lobby

4:00pm EDT

#268: Smarter Approaches to Pharmacovigilance Challenges Room 205 BC #267: Negotiating your Way Through the Vigilance Agreement Maze: Is There a Better Way? Room 204 #270: SMART-on-FHIR: Integrating Electronic Health Records as Real-World Data Room 206 #271: IDMP Standards, Structured Submissions, and Data Harmonization Methods: How Will Your Company be Impacted? Room 253 A #272: On the Path to Enlightened Conversations: Implementing Structured Content Authoring (Part 2) Room 253 C #276: Globally Accelerating the Drive to eLabeling for All Room 156 #273: An Assessment of the Challenges Associated with Cell and Gene Therapies: Are Digital Health Technologies the Way Forward? Room 205 A #274: Modernizing Clinical Trials: A Regulatory Perspective Room 253 B #277: Quality and CMC Aspects of Recent US Legislation: Challenges and Opportunities Room 151 #275: PMDA Town Hall Room 153 AB #279: Improving Patient Access with Real-World Evidence: A Framework for Coverage and Formulary Decisions Room 104 AB
 
Wednesday, June 28
 

8:30am EDT

#301: Using Real-World Data to Evaluate Safety Signals Room 205 A #302: Pharmacovigilance in Africa: Nigeria and Ghana Health Authorities Share their Perspectives Room 205 BC #308: Strategies for Benefit-Risk Analysis in Regulatory Submissions Room 204 #303: Returning Individual Participant Data: A Cultural and Operational Shift Towards Personalized Clinical Trial Options Room 254 #305: Real-World Data Quality: Components and Considerations of Data Sources Used for Regulatory Decision-Making Room 253 A #304: The Rapidly Changing Landscape of Data Collection and its Implications for Clinical Data Management Room 206 #306: Writing Summary Documents for Rare Disease Submissions: Unique Challenges Room 253 C #310: A Case Study for Illumined Therapeutic Development: Shining the Light on ALS Room 210 #307: Leveraging Project Management Skills for Significant Drug Development Deliverables Room 253 B

10:30am EDT

#315: Opportunities to Improve Risk Minimization Outcomes with Behavioral Science Room 253 C #314: Registries Aren’t Always the Answer: Novel Designs for Executing Post-Market Pregnancy Requirements Room 205 BC #316: Best Practices for Managing Rare Disease Trials in Latin America as an Emerging Region Room 254 #318: Operationalizing Real-World Data: Methods, Acceptance, and Future Hopes  Room 253 A #317: Leveraging Data Scientists and Data Managers in Clinical Data Management Room 206 #328: How Real-World Data from Wearable Biosensors and Artificial Intelligence (A)I-Based Analytics Is Enabling the Shift from Efficacy to Effectiveness Room 104 AB #319: Is the Hype Real? Real-Life User Experience of Medical Writing Artificial Intelligence Tools for Clinical Study Reports Production Room 252 #320: Combining Qualitative and Quantitative Research to Generate Within-Patient Meaningful Changes in Clinical Outcome Assessments Room 205 A #321: What Can ICH Bring to the Future of Model-Informed Drug Development (MIDD)? Room 204 #322: PI 1572 Responsibility and Oversight in Decentralized Clinical Trials Room 253 B #323: 25-Years After FDAMA: How is FDA Applying the Confirmatory Evidence Standard for Substantial Evidence of Effectiveness? Room 153 AB #325: Health Canada Town Hall Room 157 AB #326: Reliance in Action: How to Ensure Product Sameness When Using Global Supply Chains Room 151 #324: Dose Optimization in Oncology: How Do we Tackle the Tricky Topic of Combinations? Room 156

11:45am EDT

#329: Optimal Uses for Long-Term Patient Councils Content Hub NE Lobby

1:15pm EDT

#339: Operationalizing FDA Medical Queries Room 205 BC #350: Opportunities and Issues with Existing Analytical Technologies for Safety Monitoring of Ongoing Clinical Studies Room 102 #341: Managing BYOD and Wearables in Clinical Trials: Sustainable Data Collection Room 206 #342: Real-World Data Standards and Protocol Designs for Information Exchange and Data Flow  Room 253 A #343: Introduction to Estimands and Incorporation of the Estimand Framework in Protocols Room 205 A #344: Capturing the Patient Voice Using Longitudinal Qualitative Research Methods in Medical Product Development Room 204 #345: Fostering Cross-Functional Team Success by Leveraging Project Management and Alliance Management Best Practices Room 253 C #352: Performance, Interrupted: Examining Diversity, Equity, and Inclusion Dynamics that can Impact Team Performance in Drug Development Room 252 #346: Industry and Regulators’ Experience with the Implementation and Use of Remote and Electronic Consent Room 253 B #347: FDA Rare Disease Town Hall Room 153 AB #349: Evolving Global Landscape for Addressing Drug Shortages: Innovative Technology and Regulatory Strategies Room 151

4:00pm EDT

#362: Assessing Safety in Rare Disease and Gene Therapy Room 205 BC #372: Patient and Quality Impacts of Restrictions on the Use of Titanium Dioxide (TiO2) in Medicines Room 151 #373: From 1000's of Tables to Summarizing and Interactively Exploring Clinical Trials Data Room 102 #374: Critically Thinking Organization: An Action-Oriented Workshop for Leaders Room 252 #363: Modernizing the Clinical Trials Environment in Europe: ACT EU and the New EU Clinical Trial Regulation Room 253 A #365: Ethics-by-Design: Embedding Ethics into Uses of Data and Artificial Intelligence in the Pharmaceutical Industry Room 206 #366: Patient-Generated Health Data and Real-World Evidence: How Can They Be Used to Accelerate Patient Engagement and Diversity? Room 205 A #367: Leading Cross-Functional Teams Through Mergers, Divestments, and Acquisitions Room 253 C #368: Quality by Design for Real-World Evidence Studies Room 253 B #369: Mobilizing Cooperation with the African Medicines Agency Room 153 AB #370: Regulatory Reliance: Addressing Gaps to Harmonize and Enhance Uptake Globally Room 156 #371: ICH Work to Harmonize Requirements for Safe and Effective Medicines: What’s in It for Patients? Room 157 AB
 
Thursday, June 29
 

8:30am EDT

#401: Implementing the Program Safety Analysis Plan and Enhancing Ongoing Aggregate Review with an Interactive Open-Sourced Tool Room 205 BC #402: Reverse-Engineering Digital Endpoints to Improve Trial Design and Expand Diversity and Access Room 254 #403: Effective Use of Intelligent Automation in Clinical and Regulatory Room 206 #404: Implementation of the New EU Clinical Trials Regulation Room 253 C #405: CIOMS: What it Does and the Guideline on Patient Involvement in the Development, Regulation, and Safe Use of Medicines Room 205 A #406: The Value of Patient-Centric Communication Strategies Room 253 A #407: Crafting the Message: Driving Drug Development Through Compelling Governance Interactions Room 252 #410: International Medical Device Regulators Forum (IMDRF) and Technological Innovation: How International Medical Device Harmonization is Impacting Drug Strategy Room 157 AB

9:45am EDT

#412: Reporting of Pre- and Postmarket Safety Reports to FDA Adverse Event Reporting System (FAERS) Using ICH E2B Standards Room 204 #414: Process Automation and Artificial Intelligence in the Field: Practical Applications Room 206 #415: Statistical Applications of Machine Learning (ML) and Artificial Intelligence (AI) in Drug Development and Success Stories of Application Room 205 A #416: EMA-FDA Question Time Room 210

11:15am EDT

#417: FDA Town Hall Room 210
 
Filter sessions
Apply filters to sessions.
Filtered by Level (Intermediate) - 
Clear filter
Monday, June 12
Tuesday, June 13
Wednesday, June 14
Sunday, June 25
Monday, June 26
Tuesday, June 27
Wednesday, June 28
Thursday, June 29
Ballroom Lobby 3
Content Hub NE Lobby
DIA Booth #539 EH
Exhibit Hall
Exhibit Hall Entrance
Exhibit Hall South
Exhibit Hall Theater #1
Exhibit Hall Theater #2
Exhibit Hall Theater #3
Grand Ballroom
Grand Ballroom Zone 1
Grand Ballroom Zone 2
Grand Ballroom Zone 3
Grand Ballroom Zone 3A
Grand Ballroom Zone 3B
North Lobby
Outside Room 210
Room 102
Room 104 AB
Room 151
Room 153 AB
Room 156
Room 157 AB
Room 157C
Room 204
Room 205 A
Room 205 BC
Room 206
Room 210
Room 252
Room 253 A
Room 253 B
Room 253 C
Room 254
Virtual
  • 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
  • 15: Content Hubs
  • 16: Community Rounds
  • 17: Networking Opportunities
  • 18: Posters
  • 19: InnovationTheaters
  • 20: Short Courses
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Featured Topics
  • Artificial Intelligence (AI)
  • Benefit - Risk
  • Cell and Gene Therapy
  • Decentralized Clinical Trials (DCTs)
  • Digital Technology
  • Diversity Equity and Inclusion (DEI)
  • Dose Optimization
  • Endpoints
  • Ethics
  • Patient Focused
  • Rare Disease
  • Real-World Data (RWD) - Real-World Evidence (RWE)
  • Regulator Thinking
  • Regulatory Collaboration
  • Student Programming