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Wednesday, June 26

7:00am PDT

7:30am PDT

8:00am PDT

#302: Triple-s (3S) Smart Safety Surveillance Room 6D #301: So Much Data, So Little Time: Hot Topics in Benefit-Risk Assessment Room 6C #303: Disruptive Technology Transforming Clinical Trials: The Case for Artificial Intelligence, Blockchain, and Mobile Tech/Wearables Room 11A #304: Operationalizing Master Protocols Room 10 #305: Demystifying Technology Selection in Mobile Clinical Trials Room 9 #306: Methods for Integrating EHR Data into EDC and eSource Databases Room 1AB #307: Can Topic-Based Approaches to Document Authoring Help Meet the Demands of Accelerated Marketing Application Timelines? Room 4 #308: Identifying High-Value Patient Engagement Opportunities: A Collaborative Three-Step Process for Sponsors and Patient Groups Room 5AB #309: Neoantigen-Based Cancer Therapies: Regulatory Challenges and Opportunities Room 2 #310: Project Planning 101: Turning Strategy into Execution Room 15AB #311: Improving Trial Quality by Better Preparing Site Teams Room 17AB #312: Translating Academic Research into Product Development: The Importance of Understanding GLPs at an Early Stage (Part 3 of 4) Room 14A #314: Medical Devices: EU Medical Device Regulation, PMDA Updates, and US MDUFA IV – Where Are We Now? Room 6F #313: Model Integrated Evidence as Pivotal Information for Drug Regulatory Decision Making: When, Where, and Why Room 6E #315: Measuring and Assessing Product Manufacturing Quality Room 8 #316: Implementation of Innovative and Adaptive Designs in Clinical Trials Room 3 #317: Designing Clinical Trials with the Right Endpoints: Applying ICH-E9(R1) - Getting the Questions Right (GTQR),Estimands and Handling Missing Data Room 11B #319: How to Solve the Problem of Access for Rare Diseases Room 16AB #318: Opportunities and Challenges of Collecting Data in a Pre-Approval Access Setting: A Multi-Stakeholder Perspective Room 14B

9:00am PDT

9:15am PDT

9:30am PDT

9:45am PDT

10:00am PDT

10:30am PDT

#327: Digital Risk Minimization: The “Next Generation” Risk Management Tools Room 6C #328: Risk-Based Monitoring: Best Practice Today and Technology for Tomorrow Room 9 #329: Global Clinical Trials: Make Them Really Global and Involve Africa Room 10 #330: The Analytics Revolution: Opportunities and Threats for Disrupting Clinical Development Operations Room 11A #331: A Pharma/CRO Partnership in the Design and Execution of Paperless Clinical Trials from eICF to Database Lock Room 11B #332: eSource Adoption: Where We Are - Our Experiences from eSource Implementation Room 1AB #333: Pediatric Plans: The Challenges Between Regulations and Reality Room 4 #334: Understanding and Exploring Elements of a Patient-Focused Product Launch Room 5AB #335: Highlights of the Patient Engagement Preparedness, Capabilities, Experience, and Impact (PEPCEI) Study Room 14B #336: Exploring the Evolving Requirements for the Clinical Assessment of Abuse and Dependence Potential of CNS-Active Drugs Room 2 #337: Application of Project Management Methodologies and Tools in NonProfit Institutions Room 15AB #338: Expanding Use of Interactive Response Technologies in Clinical Trials: Maintaining Data Quality and Reliability Room 17AB #340: Digital Technology Advances Labeling Management and Patient Access Room 6F #341: The Evolving Gene Therapy Regulatory Framework: A Brave New World Room 6E #342: When is Real World Evidence Ready for Prime Time? Room 6D #339: Hot Topics in Quality and Regulatory Affairs for Combination Products Room 6B #343: Efficient Preparation of Global CMC Dossiers Room 8 #344: Meaningful Patient-Focused Drug Development for Rare Disease and Personalized Medicine Room 3 #345: Achieving High Performance Through Emotional Intelligence Room 14A DIAlogue Session 3: From My Crazy Career Path to Inside the Industry and How I Ended Up Here! Community Area Sails Pav

11:30am PDT

11:40am PDT

12:30pm PDT

12:40pm PDT

12:45pm PDT

1:15pm PDT

1:40pm PDT

2:00pm PDT

#373 CH: Success in the Workplace: What Does That Mean and How Can You Achieve it? Content Hub Sails Pav #374 EE: Enabling Patient-Centric Clinical Studies: TransCelerate’s Patient Engagement Tools E and E Area Exh Hall #375.1 RT: Round Table Discussion: The Elephant in the Room: Meaningful Communication of Near Synonyms as Suspected Adverse Reactions Community Area Sails Pav #375 RT: Round Table Discussion: Can Topic-Based Approaches to Document Authoring Help Meet the Demands of Accelerated Marketing Application Timelines? Community Zone Sails Pav #355: History of Risk Evaluation and Mitigation Strategies (REMS): What Have We Learned? Room 6C #356: Involving Patients in Medicinal Product Benefit-Risk Communication: How're We Doing? Room 6D #357: Accelerating Drug Development via Structured Content Reuse: Introducing the TransCelerate Clinical Template eSuite Room 11A #358: Improving the Trial Experience for Rare Disease Patients: Identifying and Overcoming Obstacles Room 9 #359: Training for the Electronic Capture of PRO Data in Clinical Trials: Views from ePRO Vendors, Sponsors, Sites, and Patients Room 10 #360: Identification of Medicinal Products: FDA's Perspective and Approach Room 1AB #361: Returning Plain Language Summaries to Research Participants: Best Practices and the Role of the IRB Room 4 #362: Patient Engagement Quality Guidance: Results and Learnings from Global Multistakeholder Pilots Room 5AB #363: Neurodegenerative Diseases: Early-Stage Challenges and Optimal Models in Drug Development Room 2 #364: Effective Portfolio Management of Assets Across an Organization Room 15AB #366: Translating Academic Research into Product Development: Integrating GCP Training into the Process (Part 4 of 4) Room 16AB #365: Leveraging Data Analytics to Drive Compliance and Quality in a Risk-Based Monitoring Environment Room 17AB #367: Model-Informed Drug Development (MIDD) and Complex Innovative Designs (CID) Programs: Where are We and What Have We Learned? Room 6B #368: Global Rare Disease Town Hall Room 6F #369: User-Fee Programs Myth Busting: General Financial Principles Explained Room 6E #370: Challenges and Opportunities in Product Quality: Lifecycle Management Room 8 #371: Efficient Pediatric Drug Development: Incorporating Innovative Techniques Using Extrapolation and Historical Information Room 3 #372: Advancing Value and Access With Technology Room 14B

3:15pm PDT

3:30pm PDT

4:15pm PDT

#379: From Trials to Real World: How Safety Protocols Impact REMS Room 6C #381: A New Path Forward for Using Decentralized Clinical Trials Room 10 #380: Incorporating Patient Input into the Design and Conduct of Clinical Trials Room 9 #382: Real World Data Quality for Regulatory Decision-Making Room 1AB #383: Next-Generation Approaches for Developing Narratives Room 4 #384: Patient Preferences in Decision Making and the PREFER Project: Past, Present, and Future Room 5AB #385: The Importance of Human Translation for Successful Preclinical Drug Discovery and Cardiac Safety Room 2 #386: Setting the Stage for Effective Stakeholder Collaboration Room 15AB #387: Global Perspective on ICH E8(R1): General Considerations for Clinical Trials Room 17AB #388: Convergence of the Regulatory Pathways for Advanced Therapy Medicinal Products Room 6F #391: Real World Evidence and Artificial Intelligence to Inform Post-Authorization Studies Room 16AB #392: Breakthrough Therapy and PRIME Expedited Regulatory Pathways: Experience, Analysis, and Reflections from EMA, FDA, and Industry Room 6D #390: Clinical Trial Innovation: Pathways for Selecting and Developing Novel, Fit-for-Purpose, Technology-Derived Study Endpoints Room 6E #389: Transparency, Expanded Access Navigator, Right to Try: Helping Patients Get Access to Investigational Medicines? Room 6B #393: Case Studies in Resolving Quality Issues Room 8 #394: Demystifying Basic Statistical Concepts for Anyone Involved with Clinical Trials Room 11B #395: Utilization and Evaluation of Innovative Approaches for Efficient Drug Development Room 3 #396: Challenges to Access: Bringing Payers to the Table Room 14B #397: PowerUp: Stories of Career Transforming Moments Room 14A

4:30pm PDT