DIA 2019 Global Annual Meeting has ended

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DIA 2019 Global Annual Meeting

9:00am PDT

SC20: #20: Real World Evidence Studies to Evaluate the Safety and Effectiveness of Therapeutic Interventions – Is the Data Fit for Purpose and How Will You Know? Room 1AB SC27: #27: eCOA 101: The What, Why, and How of eCOA to Reduce Barriers to Adoption in Clinical Studies Room 4 SC24: #24: Data Visualization in the Life Sciences Room 5AB SC22: #22: Protocol Co-Design with Patients and Advocates Room 3 SC21: #21: Basics of European Medical Device Regulation Room 2 SC23: #23: Preparing for a US FDA Advisory Committee Meeting Room 6E SC40: #40: Interdisciplinary Safety Evaluation During Product Development Room 11A SC43: #43: Back to the Future: Combination Products in the 21st Century Room 9 SC41: #41: Toolkit Approach to Best Practices in Root Cause Analysis and CAPA Management Workshop Room 8

11:00am PDT

Forum for Students and Emerging Professionals Marriott Marquis Marina

1:30pm PDT

SC30: #30: Machine Learning in Pharmacovigilance Room 5AB SC34: #34: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model Room 6D

3:45pm PDT

#002: Student and Young Professional Resume Workshop Room 14B

11:00am PDT

#105: Addressing Heterogeneity of Real World Evidence in Drug Safety Room 6D #106: Moving Forward in EU Pharmacovigilance Room 6C #107: Emerging Technologies in Clinical Research Room 11A #108: Innovation in Enrollment, Recruitment, and Retention Room 9 #109: When Disaster Strikes: Developing a Proactive Plan to Address Challenges Brought on by Large Scale Natural Disasters Room 10 #110: Automation with Intelligence: Transformation From Human Resource to Artificial Intelligence in Risk Management Room 1AB #111: PhactMI Benchmarking Survey Highlights: How are the Twenty Seven Member Companies Executing on Medical Information Initiatives Room 4 #112: Collecting Better Patient Experience Data: Lessons Learned from Patient Organizations Room 5AB #115: Quality Management Post-Quality Management System Implementation In The Wake of ICH E6 (R2) Room 17AB #116: Harnessing Power of Advanced Technologies for Digital Transformation in Regulatory Affairs Room 6F #117: International Regulatory Convergence Room 6B #118: Statistical Considerations for Trials Using Surrogate Endpoints for Accelerated Approval Room 3 #119: Making Value-Based Contracting Stick Room 11B #120: FDA Payer Communication Guidance, Twenty Years in the Making: Now What? Room 14B #121: Emerging Professionals: Making the Most of Your Networking Experience at the DIA Global Annual Meeting Room 14A

2:15pm PDT

#135: Using Real World Data to Develop a Safety Monitoring Program and Ensure Pre- and Post-Market Continuity Room 6D #136: Interpretation of New Pharmacovigilance Regulations: Key Insights Room 6C #137: Emerging Technology to Improve Sponsor-Site Interactions Room 11A #138: Blockchain in Clinical Trials Demo: Truth or Dare Room 9 #139: Developing Standard Core Clinical Outcome Assessments and Endpoints: FDA Perspective and Plans Room 10 #141: Knowledge Management and Information Sharing to Support Business Continuity Room 4 #142: Show Me the Money! Patient and Caregiver Roles and Compensation in Research, Development, and Innovation Room 5AB #143: Opportunities and Challenges with First-In-Human Multiple Expansion Cohort Designs in Oncology Room 2 #145: Examining Essential Elements of Vendor Governance and Comparing Perspectives of Large and Emerging Biopharma Room 17AB #146: Communications with Regulators Beyond Formal Meetings Room 6B #147: Update from Health Canada: The Health Protection Branch Room 6F #151: Update on ICH Quality Topics Room 8 #152: Making Data Meaningful: Using Data Visualization to Drive Efficiency in Safety Analysis Room 3

3:30pm PDT

#154: Current Initiatives on Patient Involvement in the Medicinal Product Lifecycle: CIOMS XI Room 6C #155: Incorporating Systems-Theory and Human Factors into the Investigations of Serious Harm in Clinical Research Room 6D #156: Clinical Research in Emerging Regions Room 9 #157: A Large Academic Medical Center’s Perspective on Using Precision Medicine to Find Patient Disease Subgroups at Scale Room 11A #158: Enhancing Patient-Focused Outcome Assessment in Medical Product Development Room 10 #159: Understanding the Data Journey In Virtual Trials Room 1AB #160: New Communication Channels for Medical Information Room 4 #162: Precision Medicines in Clinical Trials: Understanding and Overcoming Barriers to Adoption Room 2 #164: Compliance: The Importance of Periodic Screenings to Ensure Good Inspection Health Room 17AB #165: Drug Development Tools in a Digital Era Room 6F #166: Updates on China Regulatory Reform Room 6E #167: Strategic Priorities of the International Coalition of Medicines Regulatory Authorities in an Increasingly Globalized Industry Room 6B #168: Regulating Innovation in Chemistry, Manufacturing, and Controls: Challenges and Opportunities Room 8 #170: Making Early Access for Patients Happen Room 14B #171: The Courage of Career Transitions Room 14A

8:00am PDT

#202: Updates and Lessons Learned from Novel Approaches to Pharmacovigilance Collaboration Room 6D #201: To Err is Human: Progress and Challenges in the Prevention of Medication Errors Room 6C #203: eConsent Done Right Room 11A #204: Protocol Developments of the Future Room 9 #205: Driving Enrollment with a Patient-Centric Focus to Artificial Intelligence Room 10 #208: Patient Focus as Part of the Regulatory Affairs DNA: Opportunities and Challenges Room 5AB #209: Emerging Issues in CRISPR and Gene Editing Symposium Room 2 #212: Translating Academic Research into Product Development: Integrating GXPs into the Process (Part 1 of 4) Room 16AB #211: Pharmacovigilance Reporting and Quality Room 17AB #213: Facilitating Access: Patient Perspectives on a Streamlined Development Approach for Treatments for Severely-Debilitating or Life-Threatening Diseases Room 6B #214: Global Pediatric Policy Update: Are You Ready to Implement FDARA Section 504? Room 6F #215: Conducting Clinical Trials with GMOs: Strategies to Overcome Regulatory, Operational, and Patient Enrollment Challenges Room 6E #217: Quality Considerations for Complex Generics Room 8 #219: Personalized Healthcare and Clinical Outcomes: How Real World Endpoints Can Improve Approval and Access to Medicine? Room 14B

10:30am PDT

#229: An Industry Collaboration on Pharmacovigilance Analytics Room 6C #230: Assessing Opportunities to Improve Outsourcing Oversight and the Vendor Qualification Assessment Process Room 10 #231: Outcomes, Endpoints, and Methods Supporting Oncology and Alzheimer Therapies Room 9 #232: Retooling Risk Assessment to Align with ICH-E6(R2) and Connect to Centralized Monitoring and Risk-Based Monitoring Room 11A #233: Creating Clarity: Changes at CDISC to Make Standards Implementation Easier for all Stakeholders Room 1AB #234: Quality and Compliance Management in Medical Information/Medical Affairs Room 4 #238: Build and Leverage Your Networks to Influence Stakeholders Room 15AB #239: Improving Clinical Trial Risk Management: How To Leverage the IRB's Designed Purpose Room 17AB #240: Harmonizing Regulatory Science Through the International Council for Harmonization (ICH) Room 6F #241: PMDA Town Hall Room 6E #242: Use of Real World Evidence to Support Regulatory Decision-Making: First-Year Findings From the RCT-DUPLICATE Project Room 6B #244: Where Quality Meets Safety and Efficacy: A Conversation with CMC Experts Room 8 #246: How Employers are Reinventing Healthcare and What it Means for Research Participation and Evidence Room 14B #247: Pregnancy, Breastfeeding, Childcare, Oh My! Finding a Balance for New Moms Room 14A

2:00pm PDT

#255: Pharma and Regulatory Perspectives on Machine Learning Applications in Pharmacovigilance Room 6C #256: Wearables and Patient Technologies Utilized in Clinical Trials Room 10 #257: Clinical Trial Diversity: Moving from Admiring the Problem to Solving it Room 11A #258: Build-a-Bot Workshop: Design and Build a Conversational Agent that Speaks for You Room 9 #259: FDA Data Standards Update Room 1AB #261: Patient Experience Data: How Could this Data Enhance Decision-Making at Different Stages of Medical Product Development? Room 5AB #264: Immuno-Oncology Product Development: Overcoming Scientific and Regulatory Challenges Room 2 #263: Drug Development for Ocular Disease, New Therapies, Regulations, and Patient Perspectives Room 6D #266: Electronic Systems: Are Yours Fit for Purpose? Room 17AB #267: Translating Academic Research Into Product Development: The What and Why of cGMP in Translational Science (Part 2 of 4) Room 11B #268: Current Status of FDA Framework for the Evaluation of Real World Evidence Room 6B #269: Driving Complex Generics to Approval: What are the Keys to Success Room 6F #270: Where Quality Meets Safety and Efficacy: An Interactive Experience Room 8 #271: Master Protocols: Applications in Oncology Room 3 #272: Aligning Facilitated Regulatory and Access Pathways: Observations from the North American Experience Room 14B #273: Presentations as Listeners Like Them: How to Tailor Messaging Room 14A

4:15pm PDT

#281: Structured Evidence Planning, Production, and Evaluation (SEPPE): A “Quality-Based” Framework for Drug Development Room 6C #282: The Elephant in the Room: Meaningful Communication of Near Synonyms as Suspected Adverse Reactions Room 6D #283: Let's Talk Risk-Based Monitoring Room 9 #284: Virtual Clinical Trials Room 10 #287: A Case Study in Structuring Clinical Content and Structured Content Management (SCM) Room 4 #288: The Changing Landscape of Medical Affairs: Are We Prepared For 2020? Room 11B #289: Impact of Patient Engagement on the Biopharmaceutical Industry's Business and Organization Room 5AB #290: The Responsibility Industry, Agencies, and Early Education own in Cure-Model Based Therapeutics Room 16AB #295: Prescription Drug Labeling: New Guidances from the US FDA Room 6B #296: Informing Development and Authorizations Using Real World Evidence/Artificial Intelligence Room 6E #298: Clinical Safety Assessment: What’s a Statistician Got to Do with It? Room 3 #299: Public and Regulatory Response To Drug Pricing Concerns Room 14B

8:00am PDT

#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 #309: Neoantigen-Based Cancer Therapies: Regulatory Challenges and Opportunities Room 2 #310: Project Planning 101: Turning Strategy into Execution Room 15AB #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 #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

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 #333: Pediatric Plans: The Challenges Between Regulations and Reality Room 4 #334: Understanding and Exploring Elements of a Patient-Focused Product Launch Room 5AB #336: Exploring the Evolving Requirements for the Clinical Assessment of Abuse and Dependence Potential of CNS-Active Drugs Room 2 #338: Expanding Use of Interactive Response Technologies in Clinical Trials: Maintaining Data Quality and Reliability Room 17AB #341: The Evolving Gene Therapy Regulatory Framework: A Brave New World Room 6E #339: Hot Topics in Quality and Regulatory Affairs for Combination Products Room 6B #344: Meaningful Patient-Focused Drug Development for Rare Disease and Personalized Medicine Room 3

2:00pm PDT

#373 CH: Success in the Workplace: What Does That Mean and How Can You Achieve it? Content Hub Sails Pav #355: History of Risk Evaluation and Mitigation Strategies (REMS): What Have We Learned? Room 6C #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 #366: Translating Academic Research into Product Development: Integrating GCP Training into the Process (Part 4 of 4) Room 16AB #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 #372: Advancing Value and Access With Technology Room 14B

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 #391: Real World Evidence and Artificial Intelligence to Inform Post-Authorization Studies Room 16AB #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 #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

9:00am PDT

#403: Successes and Challenges in Pharmacovigilance for Biologics and Biosimilars Room 6D #404: Investigational Medicinal Products: eLabeling Initiative, Supply Forecasting Strategies, and Patient-Centric Technology for Medicine Adherence Room 11A #405: eSource and the Sites: Have They Bonded? Room 10 #406: Electronic Submissions Update Room 1AB #407: A Patient Engagement Wrap Up: Lessons Learned from DIA 2019 and Where Do We Go from Here Room 5AB #408: FDA Botanicals Room 2 #409: Case Studies From FDA and MHRA: Good Clinical Practices Room 6C #410: Advancing Benefit-Risk Assessment to Support FDA’s Regulatory Review of Human Drugs and Biologics Room 6F #411: Recent CMC Changes in Emerging Regulatory Agencies Room 8 #412: Keeping Up with FDA and EMA Collaborations: Question Time Room 6B

10:45am PDT

#413: FDA Town Hall Room 6B