DIA 2018 Global Annual Meeting has ended

Create Your Own Event

DIA 2018 Global Annual Meeting

10:30am EDT

#000: Emerging Professionals and Student Forum Commonwealth Room Westin

11:00am EDT

#107: The Metamorphosis of Clinical Trials: Evolving Roles of Stakeholders in Digital Trials Room 257AB #117: Beyond Robotics Process Automation: Next Generation Integrated QMS for R&D Room 205C #122: Contracting for Value: From Outcomes-Based Contracts to Bundled Payment Programs: What’s Working and Why Room 252AB #109: The Who, What, How, When, and Why of Using Mobile Technology in Clinical Trials Room 258C #113: Patient-Focused Medicines Development: Where It has Led Us to Today, What Challenges Remain, and What Do We Still Need to Do to Achieve Success? Room 151AB #114: A Hot Debate: Perspectives on Benefit and Risk From Patients Across Diseases Room 153ABC #118: How Can We Optimally Incorporate Real World Evidence into Regulatory Decision-Making? Room 205AB #124: Analyzing Innovations Progress in the Gottlieb Era Room 210AB

1:45pm EDT

#133: DIA Good Clinical Practices and QA Community Round Table Discussion: Data Integrity Playbook: A Cross-Functional, Risk-Based, Analytics-Driven Approach to Monitor Data Integrity Community Zone NE Lobby #134: DIA Medical Writing Community Round Table Discussion: Scientific Communication Key Message Development, Management, and Dissemination Community Zone NE Lobby

3:00pm EDT

#144: The Evolving Biosimilars Landscape: A Medical Affairs Perspective Room 210C #145: A New Ecosystem: The Nature of Relationships Between Patient Advocacy Groups and Sponsors Room 153ABC #150: TFDA Town Hall Room 208 #156: International Regulatory Convergence Room 210AB

8:00am EDT

#201: Generic Drug Products: Comparison of Safety Profile With Branded Cousin Room 253AB #206: Incorporating Patient Input Into US Food and Drug Administration’s Medical Product Development and Regulatory Decision Making Room 151AB #208: Effective Management of Internal Stakeholders and External Strategic Partners from Multiple Perspectives: Non-Profit, CRO, and Pharmaceutical Industry Room 153ABC #210: Artificial Intelligence: The Future of Regulatory Affairs Room 206AB #211: Update on Collaboration and Trends in Global Companion Diagnostics Room 208 #213: 2018 Policy Mash-Up: New Shifts in the Healthcare Market and What They May Mean for Patients and the Biopharma Industry Room 205AB #217: Triple-A RWE: Adequate Data, Appropriate Study Designs, and Actionable Evidence Room 210AB

9:30am EDT

#221: DIA Regulatory Community Round Table Discussion: Artificial Intelligence: The Future of Regulatory Affairs Community Zone NE Lobby #222: DIA Patient Engagement Community Round Table Discussion: New Ecosystem: The Nature of Relationships Between Patient Advocacy Groups and Sponsors Community Zone NE Lobby

10:30am EDT

#236: Executives Respond to the State of the Industry Report on Risk-Based Approaches in Clinical Trials: Opportunity or Threat? Room 205C #227: Digital Data Flow from Protocol to Report: TransCelerate’s Common Protocol Template and the Art of the Possible Room 257AB #229: Mobile Reported Outcomes: A Forum on Patient and Caregiver Assessments Room 258C #233: The Patient's Assessment of the Patient-Focused Drug Development Meeting Initiatives Room 151AB #239: Generic Drug Town Hall Room 205AB #242: Unmet Medical Need: Can the Stakeholders Align? Progress to Date Room 153ABC #243: Global Perspectives on Patient Engagement Room 210AB

2:00pm EDT

#269A: DIA Regulatory Community Round Table Discussion: Global Regulatory Strategies for Biosimilars Community Zone NE Lobby #253: Digitizing a Patient-Focused Clinical Trial Experience Room 258AB #258: Reaching the Underserved: Methods to Ensure Diversity and Inclusion for Patient Research, Clinical Trials, and Advisory Panels Room 151AB #261: Project Management Throwdown: How Not to Get Chopped Room 153ABC #268: Future of PharmaTech Room 210AB

3:15pm EDT

#270: DIA Medical Writing Community Round Table Discussion: Digital Data and New Technologies to Drive Customer Impact in Medical Affairs, Medical Writing, and Medical Communications Community Zone NE Lobby #271: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Risk Management - New Directions Community Zone NE Lobby

4:15pm EDT

#288: Is It Time to Change the Content and Format of Labeling? Room 205AB #278: Challenges and Opportunities in Data Access and Methodology Development for Post-Market Generic Drug Monitoring Room 252AB #279: Redefining the Site Investigator's Experience Room 153ABC #280: Debunking Decentralized Trials: Sharing Breakthroughs and Deal Breakers Room 254AB #281: Future of Endpoints Room 258C #283: Evolving Roles and Responsibilities for Medical Affairs Professionals Room 210C #286: Which Regulatory Project Management Staff at FDA Should You Engage With? When and How? Room 157AB #291: ICH Q12: A Paradigm Changing Guidance for Post-Approval Changes? Room 208

4:30pm EDT

#295: DIA Devices and Diagnostics Community Round Table Discussion: Navigating the Regulatory Landscape of Drug-Device Combination Products Community Zone NE Lobby #296: DIA Medical Writing Community Round Table Discussion: CTD Regulatory Defense Strategies - How Best to Prepare Your Response to Health Authority Queries Community Zone NE Lobby

8:00am EDT

#319: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Pharmacovigilance: No Longer Going It Alone Community Zone NE Lobby #320: DIA Patient Engagement Community Round Table Discussion: Reaching the Underserved - Methods to Ensure Diversity and Inclusion for Patient Research, Clinical Trials, and Advisory Panels Community Zone NE Lobby #312: Harmonizing Regulatory Science Through the International Council for Harmonisation (ICH) Room 206AB #313: Global Rare Disease Town Hall Room 205AB #314: What Can We Say About Combination Products? Labeling, Advertising and Promotion of Combination Products Room 204AB #318: Value-Based Assessment and Contracting: What Needs to be Done to Make it a Best Practice? Room 210AB

9:30am EDT

#324: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Patient Engagement in Pharmacovigilance Community Zone NE Lobby #325: DIA Clinical Data Management Community Round Table Discussion: The Letter and Spirit of Risk-Based Monitoring - How to Creatively Implement the RBM and Unlock the Potential of the Team Community Zone NE Lobby

10:30am EDT

#337: Balancing Regulatory, Medical, and Operational Pillars to Get Pediatric Trials Done Globally Room 156ABC #330: Artificial Intelligence: Robots Taking Over Clinical Research Room 253C #335: Collaboration Across the Medical Affairs Ecosystem to Advance Patient Care Room 257AB #336: Addressing the Elephant in the Room: A Hard Look at Metrics, Legal, Payers, and Other Leading Obstacles Facing the Sustainability of Patient Engagement Room 153ABC #340: Harmonization Beyond ICH Room 206AB #341: New FDA Draft Guidance on Part 11 in Clinical Investigations Room 204AB #344: Biosimilar Interchangeability: A Global Perspective Room 205AB #346: Precision Medicine, Gene Editing, and Gene Therapy: Current Status and Regulatory Challenges of Integrating Genetic Medicine into Clinical Care Room 210AB

1:00pm EDT

#352: DIA Clinical Pharmacology Community Round Table Discussion: Evolution and Harmonization of First-in-Human Guidelines Community Zone NE Lobby #353: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Automation in Pharmacovigilance - Doing More With Less Community Zone NE Lobby

2:00pm EDT

#358: Expedited E2B Safety Reporting in Interventional Clinical Trials: Convergence of Global Expectations? Room 253AB #359: IMEDS: A Collaboration Based on the FDA's Sentinel Initiative Room 253C #360: Implementation of eConsent and Other Digital Clinical Trial Innovations Room 258AB #368: Predicting Future Generic Drug Competition: Powering Strategic Planning Using Quantitative Methods and Modeling Room 153ABC #370: Clinical Outcome Assessments (COA) Endpoints for Use in Rare and Ultra-Rare Disease Clinical Trials Room 204AB #371: What's New in Health Canada: Updates and New Endeavors Room 205C #373: PMDA Town Hall Room 205AB

3:00pm EDT

#378: DIA Devices and Diagnostics Community Round Table Discussion: What Can We Say About Combination Products? Labeling, Advertising and Promotion of Combination Products Community Zone NE Lobby #379: DIA Clinical Trial Disclosure and DIA Medical Communication Communities' Round Table Discussion: Clinical Trial Disclosure: Learnings from EMA Policy 0070, NIH Final Rule, and FDA’s Clinical Data Summary... Community Zone NE Lobby

4:00pm EDT

#394: Update on BREXIT Room 205AB #398: The Impact of Cell and Gene Therapy on the Payer System Room 204AB #382: Artificial Intelligence: A Disruptive Journey for Pharmacovigilance Room 253AB #384: Innovations in Managing Global Clinical Supplies Room 258AB #389: Patient Observation Versus Patient Engagement: Optimizing Development Room 151AB

8:00am EDT

#401: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Risk Management: Artificial Intelligence - A Disruptive Journey for Pharmacovigilance Community Zone NE Lobby #402: DIA Patient Engagement Community Round Table Discussion: Addressing the Elephant in the Room - A Hard Look at Metrics, Legal, Payers, and Other Leading Obstacles Facing the Sustainability of Patient Engag... Community Zone NE Lobby

9:00am EDT

#408: Innovative Funding Models for Novel Therapeutics Room 206AB #404: Biologics and Biosimilars: Payers, Industry, and Academia Collaborating on Post-Marketing Surveillance Room 204AB #411: Regulatory and Industry Perspectives on the Common Protocol Template Room 253C #415: EMA/FDA Question Time Room 210AB

10:45am EDT

#416: FDA Town Hall Room 210AB