DIA 2022 Global Annual Meeting

11A: “Has it Happened Already?” Questions of Precedent from Which Regulatory Intelligence Can Save You 10:00am - 1:00pm

12P: Defining the Clinical Questions of Interest: Why Everyone Developing a Protocol Should Understand Estimands! 2:00pm - 5:00pm

21A: Talking Statistics: Interpreting Statistical Results for Non-Statisticians Involved in Clinical Trials 10:00am - 1:00pm

22P: Machine Learning in Pharmacovigilance 2:00pm - 5:00pm

23P: Real-World Evidence: The Evolving Landscape of Regulators, Data, and Integrated Use 2:00pm - 5:00pm

32A: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks throughout the Drug Development Lifecycle 10:00am - 1:00pm

31A: Global AdPromo: Considerations for Compliance and Success 10:00am - 1:00pm

33P: Presentation of Safety Risks Throughout the Product Lifecycle Framework: Key Findings and Practical Uses 2:00pm - 5:00pm

41A: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development 8:00am - 11:00am

42P: Become a DCT Master: Understanding the Lifecycle of Decentralized Clinical Trials 2:00pm - 5:00pm

Luncheon Service 11:30am - 1:00pm

Refreshment Break 2:15pm - 4:00pm

DIA Welcome Reception supported by Change Healthcare 5:00pm - 6:00pm

Annual Meeting of Members 2:30pm - 3:15pm

#102 IT: Syneos Health Innovatio... 11:50am - 12:20pm

#106 IT: IQVIA Innovation Theate... 12:35pm - 1:05pm

#125 IT: PPD, part of Thermo Fis... 2:40pm - 3:10pm

#129 IT: Precision for Medicine... 3:20pm - 3:50pm

#147 IT: Care Access Innovation... 5:15pm - 5:45pm

#101 IT: Advanced Clinical Innov... 11:50am - 12:20pm

#105 IT: CRIO Innovation Theater... 12:35pm - 1:05pm

#126 IT: Medable Innovation Thea... 2:40pm - 3:10pm

#130 IT: Deloitte Innovation The... 3:20pm - 3:50pm

#148 IT: Parexel Innovation Thea... 5:15pm - 5:45pm

#103 IT: Microsoft Innovation Th... 11:50am - 12:20pm

#107 IT: SAS Innovation Theater:... 12:35pm - 1:05pm

#127 IT: RWS Innovation Theater:... 2:40pm - 3:10pm

#128 IT: Castor Innovation Theat... 3:20pm - 3:50pm

#146 IT: Labcorp Innovation Thea... 5:15pm - 5:45pm

#01 POS : Poster Session I 12:00pm - 1:15pm

#108: Support of IND Safety Reporting by the Aggregate Safety As... 1:15pm - 2:15pm

#132: ICH E2D Update: Innovations in Collecting Safety Data from... 4:00pm - 5:00pm

#109: Risk-Based Monitoring in Clinical Trials: An Evolution of... 1:15pm - 2:15pm

#133: New Tools for Creating Flexible and Sustainable Master Pro... 4:00pm - 5:00pm

#110: Adaptive Designs Save Time and Money: Regulatory Agencies... 1:15pm - 2:15pm

#134: FDA Update on the Upcoming PDUFA VII Data and Technology C... 4:00pm - 5:00pm

#111: The Role of Sensors in Clinical Research: Integrating Sens... 1:15pm - 2:15pm

#136: Developing and Implementing a Strategic Framework to Guide... 4:00pm - 5:00pm

#112: ICH Q2 (R2) and Q14: Can We Realize the Vision for Risk-Ba... 1:15pm - 2:15pm

#142: The Future of CMC Regulatory Submissions: Streamlining Act... 4:00pm - 5:00pm

#116: Incorporating Patient Experience Data in Global R&D 1:30pm - 2:30pm

#114: Data Integrity Across the Product Lifecycle 1:30pm - 2:30pm

#143: A Targeted Learning Framework for Causal Effect Estimation... 4:00pm - 5:00pm

#117: The Translational Value of Animal Models in Rare Diseases 1:30pm - 2:30pm

#144: Value of Patient Experience Data in Healthcare Decision-Ma... 4:00pm - 5:00pm

#118: Real-World Evidence Frameworks Across the World: Three Int... 1:30pm - 2:30pm

#140: ICMRA: COVID-19 Response and International Collaboration 4:00pm - 5:00pm

#120: Practical Applications of the Estimand Framework in Novel,... 1:30pm - 2:30pm

#138: ICH E8(R1): Regulators' Perspectives on Quality-by-Design... 4:00pm - 5:00pm

#121: Identifying Value and Driving Access to Drug-Based Product... 1:30pm - 2:30pm

#131: Innovations for Implementing REMS 4:00pm - 5:00pm

#115: Scientific Communication During a Pandemic: The Ethics of... 1:30pm - 2:30pm

#137: Successful Virtual Partnering 4:00pm - 5:00pm

#119: Is it Time to Change the Accelerated Approval Pathway? 1:30pm - 2:30pm

#139: FDA and EMA Benefit-Risk Assessments: Can We Optimize and... 4:00pm - 5:00pm

#124 RT: Round Table Discussion: Support of IND Safety Reporting... 2:30pm - 3:30pm

Annual Meeting Orientation 9:00am - 9:45am

#113: Fostering Innovation and Psychological Safety 1:15pm - 2:15pm

#122 CH: Transgender and Non-Bin... 2:30pm - 3:00pm

#145: Design Thinking: The Empathy Map 4:00pm - 5:00pm

#104 CH: What Do Patients Want F... 12:15pm - 12:45pm

#123 CH: Mastering the Science o... 2:30pm - 3:00pm

#135: Demystifying the Delivery of Healthcare Economic Informati... 4:00pm - 5:00pm

#002 STU: Collective Connections: Networking wit... 3:00pm - 3:45pm

DIA Student Case Competition Presentation 4:00pm - 5:00pm

#100: Opening Plenary: The Future of Healthcare 10:00am - 11:30am

Coffee Service 8:00am - 10:00am

Community Networking Lunch 12:00pm - 4:45pm

Coffee Break 10:00am - 11:15am

Luncheon Service 12:00pm - 1:30pm

Refreshment Break 2:45pm - 4:30pm

#217 IT: Flatiron Health Innovat... 10:20am - 10:50am

#235 IT: Veeva Innovation Theate... 12:25pm - 12:55pm

#238 IT: Precision for Medicine... 1:05pm - 1:35pm

#259 IT: UBC Innovation Theater:... 3:10pm - 3:40pm

#263 IT: Certara Innovation Thea... 3:50pm - 4:20pm

#216 IT: Clario Innovation Theat... 10:20am - 10:50am

#233 IT: JMP Statistical Discove... 12:25pm - 12:55pm

#239 IT: IQVIA Innovation Theate... 1:05pm - 1:35pm

#258 IT: IBM Watson Health Innov... 3:10pm - 3:40pm

#264 IT: Veeva Innovation Theate... 3:50pm - 4:20pm

#218 IT: Twilio for Life Science... 10:20am - 10:50am

#234 IT: Labcorp Innovation Thea... 12:25pm - 12:55pm

#240 IT: Microsoft Innovation Th... 1:05pm - 1:35pm

#260 IT : Appian Innovation Thea... 3:10pm - 3:40pm

#265 IT: M-Files Innovation Thea... 3:50pm - 4:20pm

#02 POS: Poster Session II 12:00pm - 1:15pm

Coffee Service 8:00am - 9:00am

#201: Transforming PV at the MHRA 9:00am - 10:00am

#223: Meeting Regulatory Expectations: What Needs to be Consider... 11:00am - 12:00pm

#242: Risk Minimization for Health Products: What are we Learnin... 1:45pm - 2:45pm

#267: Improving Safety Data Through Innovative Use of Technology 4:15pm - 5:15pm

#202: Innovations in Risk Minimization: Methods, Tools, and Desi... 9:00am - 10:00am

#219: Post-Approval Safety Studies: Approaches to Assessing Medi... 11:00am - 12:00pm

#243: Technology-Enabled Clinical Trials Using Electronic Health... 1:45pm - 2:45pm

#276: Rethinking Fundamental ICH CMC Guidelines: Analytical Proc... 4:15pm - 5:15pm

#203: The Site Landscape: Data and Discussion of the State of th... 9:00am - 10:00am

#225: Solving for ‘Shared Value’ of Cell and Gene Therapy with R... 11:00am - 12:00pm

#241: Drug Safety in Africa: New PV Horizons 1:45pm - 2:45pm

#266: FDA's Updates on Ensuring Post Market Safety and Surveilla... 4:15pm - 5:15pm

#204: Diversity and Inclusion in Clinical Trials: Concrete Strat... 9:00am - 10:00am

#224: ICMRA Update: Convergence and Collaboration on COVID-19 -... 11:00am - 12:00pm

#244: Planning and Conducting Efficient, High-Quality Decentrali... 1:45pm - 2:45pm

#274: Regulatory Convergence Successes and Opportunities 4:15pm - 5:15pm

#205: Optimizing Evidence Supporting Fit-for-Purpose Digital Cli... 9:00am - 10:00am

#220: Collection of Quality Endpoint Data in a Decentralized Tri... 11:00am - 12:00pm

#245: Understanding the Consumer's Journey for Information From... 1:45pm - 2:45pm

#270: Recommendations for Conducting Bring Your Own “Device” (BY... 4:15pm - 5:15pm

#215: Efforts Toward Global Convergence of CMC and GMP Expectati... 9:15am - 10:15am

#222: Patient-Focused Drug Development: Reflecting on a Decade o... 11:00am - 12:00pm

#249: Regulatory-Grade Real-World Evidence: Distilling to Practi... 2:00pm - 3:00pm

#268: Life Science Research Innovation Powered by Real-World Dat... 4:15pm - 5:15pm

#210: Challenges of Translational and Early-Phase ASO Developmen... 9:15am - 10:15am

#228: Individualized Therapeutics: Walking the Line Between Rese... 11:15am - 12:15pm

#251: Data Science, Text Analytics, and Machine Learning to Deri... 2:00pm - 3:00pm

#275.1: PMDA Town Hall 4:15pm - 5:15pm

#207: Enhancing Interactions Among Stakeholders to Advance Patie... 9:00am - 10:00am

#227: Approaching the Assessment of Clinical Protocol Complexity 11:15am - 12:15pm

#250: Patients as Central Partners in COA Design 2:00pm - 3:00pm

#269: Strategic Planning in Selecting the Right Countries and Si... 4:15pm - 5:15pm

#209: New EU Clinical Trial Regulation: Experience So Far 9:15am - 10:15am

#232: Preparing for the Future of Research and Development:10-Ye... 11:15am - 12:15pm

#252: International Collaborations: What’s New in Oncology? 2:00pm - 3:00pm

#271: Building the First Cloud-Based Submission Review Collabora... 4:15pm - 5:15pm

#212: Where Are We with Antimicrobial Resistance (AMR) in the Re... 9:15am - 10:15am

#229: Accelerating Cell and Gene Therapy Development Through Int... 11:15am - 12:15pm

#253: Efforts to Improve Diversity of Clinical Trial Participant... 2:00pm - 3:00pm

#277: Quantitative Benefit-Risk Approaches in Drug Development a... 4:15pm - 5:15pm

#214: New Policy Developments in Combination Products 9:15am - 10:15am

#226: Simulating Trial Activities with Patients: Our Experiences 11:15am - 12:15pm

#247: Paying for Digital Health: What Evidence is Needed? 1:45pm - 2:45pm

#275: How to Interact with Regulators to Qualify a Digital Mobil... 4:15pm - 5:15pm

#211: Shifting the Audit Paradigm for a More Effective Outcome 9:15am - 10:15am

#230: Asia Town Hall 11:15am - 12:15pm

#248: Healthcare Datasets as Assets: Secure and Compliant Valuat... 2:00pm - 3:00pm

#272: Fit-for-Purpose Patient Preference Studies: Emerging Recom... 4:15pm - 5:15pm

#213: Reflections on PDUFA: A Look Back at PDUFA VI and A Previe... 9:15am - 10:15am

#231: Leveraging Real-World Evidence for Regulatory Purposes 11:15am - 12:15pm

#254: Overcoming Challenges in Pediatric Product Development 2:00pm - 3:00pm

#278: FDA Real-World Evidence Guidance for Regulatory Approval:... 4:15pm - 5:15pm

#236 RT: Round Table Discussion: FDA Update on the Upcoming PDUF... 12:30pm - 1:30pm

#256 RT: Round Table Discussion: Technology-Enabled Clinical Tri... 3:00pm - 4:00pm

#237 RT : Round Table Discussion: Individualized Therapeutics: W... 12:30pm - 1:30pm

#257 RT: Round Table Discussion: Enhancing Interactions Among St... 3:00pm - 4:00pm

#208: Keeping Passion for Project Management Alive 9:00am - 10:00am

#237.2 CH: Location, Location, L... 12:45pm - 1:15pm

#255: Demystifying Statistical Concepts for Non-Statisticians In... 2:00pm - 3:00pm

#261 CH: How Drug Development Wi... 3:30pm - 4:00pm

#279: Decision Making and Decision Science;: Learn to Make Bette... 4:15pm - 5:15pm

#206: The Future of Content Authoring and Web Portal Technology,... 9:00am - 10:00am

#221: Complying with the EU-CTR Disclosure Standards in the Era... 11:00am - 12:00pm

#237.1 CH: Emerging Editorial Po... 12:45pm - 1:15pm

#246: Project Management Across the Healthcare Continuum 1:45pm - 2:45pm

#262 CH: Mentoring 101 3:30pm - 4:00pm

#273: IMPALA (IntercoMPany quALity Analytics) Industry Group: Da... 4:15pm - 5:15pm

#003 STU: Career Ladder or Career Lattice? Strat... 12:45pm - 1:30pm

Poster Showcase Session 4:15pm - 4:45pm

DIA Publications Meet and Greet: Overview and Opportunities 5:00pm - 6:00pm

Coffee Break 10:00am - 11:15am

Luncheon Service 12:00pm - 1:30pm

Refreshment Break 2:45pm - 4:30pm

#314 IT: Datacubed Health Innova... 10:20am - 10:50am

#331 IT: IQVIA Innovation Theate... 12:25pm - 12:55pm

#339 IT: Parexel Innovation Thea... 1:05pm - 1:35pm

#358 IT: Axiom Innovation Theate... 3:10pm - 3:40pm

#362 IT: PointClickCare Innovati... 3:50pm - 4:20pm

#315 IT: RxTROSPECT Innovation T... 10:20am - 10:50am

#332 IT: Deloitte Innovation The... 12:25pm - 12:55pm

#338 IT: Evernorth Innovation Th... 1:05pm - 1:35pm

#359 IT: Calyx Innovation Theate... 3:10pm - 3:40pm

#364 IT: Florence Healthcare Inn... 3:50pm - 4:20pm

#316 IT: ATCOR Medical Innovatio... 10:20am - 10:50am

#333 IT: Curebase Innovation The... 12:25pm - 12:55pm

#337 IT: Yseop Innovation Theate... 1:05pm - 1:35pm

#357 IT: Labcorp Innovation Thea... 3:10pm - 3:40pm

#363 IT: ZS Innovation Theater:... 3:50pm - 4:20pm

Coffee Service 8:00am - 9:00am

#305: What’s New at ICH? From the E11A Pediatric Extrapolation G... 9:00am - 10:00am

#317: Let’s Make a PV Agreement: Four Solutions You Can Use to E... 11:00am - 12:00pm

#341: New Approaches to Site Selection in Clinical Trials 1:45pm - 2:45pm

#365: Field of Dreams: If We Build it, Will they Come? Using Imp... 4:15pm - 5:15pm

#302: Mission-Driven Research Partners: How Patient Advocacy Org... 9:00am - 10:00am

#320: De-Risking Decentralized: Understanding the Dimensions of... 11:00am - 12:00pm

#342: Democratizing Data for Cancer Research and Real-World Evid... 1:45pm - 2:45pm

#367: Local Conduct for Global Clinical Trials: Focus on Japan,... 4:15pm - 5:15pm

#301: Uses of Artificial Intelligence for PV in the Context of C... 9:00am - 10:00am

#318: Rare Disease Data Sharing: A Value Proposition 11:00am - 12:00pm

#340: Monitoring COVID-19 Vaccine Safety 1:45pm - 2:45pm

#366: Development of Standard Core Sets of Clinical Outcome Asse... 4:15pm - 5:15pm

#319: Ensuring Diversity in Clinical Trials 11:00am - 12:00pm

#343: Redefining the Value Proposition for Innovation: Connectin... 1:45pm - 2:45pm

#378: US Health Care System Adoption of a Class of New Technolog... 4:15pm - 5:15pm

#307: Improve the Speed and Cost of Clinical Trials With Bayesia... 9:00am - 10:00am

#321: FHIR in Clinical Research 11:00am - 12:00pm

#345: Statistical Issues in Master Protocols: Beyond Type I Erro... 1:45pm - 2:45pm

#371: Reimbursement, Compensation, and Incentives: Best Practice... 4:15pm - 5:15pm

#325: Assessing and Integrating Patient Preferences into Treatme... 11:15am - 12:15pm

#351: Health Canada Town Hall 2:00pm - 3:00pm

#368: Sneak Peak: First Share from Initiatives of a Global Colla... 4:15pm - 5:15pm

#308: Community and Patient Engagement: Putting Research into Co... 9:15am - 10:15am

#328: Approaches to Health Authority Collaboration: Are They Fit... 11:15am - 12:15pm

#353: Planning for the Worst: Approaches for Drug Shortage Avoid... 2:00pm - 3:00pm

#373: Effective Oversight Strategies of CROs and Digital Technol... 4:15pm - 5:15pm

#306: Leveraging Best Practices and Tools from the Discipline of... 9:00am - 10:00am

#324: The Value of Medical Writing: The Regulator's Perspective,... 11:15am - 12:15pm

#354: How Can Population Decisions Makers and Pharmaceutical Com... 2:00pm - 3:00pm

#376: How to Manage Device Design Changes Under EU MDR 4:15pm - 5:15pm

#312: COVID-19 360°: Embedding Global Best Practices in Routine... 9:15am - 10:15am

#330: Leveraging Real-World Evidence to Address Diversity Gaps i... 11:15am - 12:15pm

#347: Enabling Digital Transformation in Health Care and Clinica... 2:00pm - 3:00pm

#374: Around the World: Regulator Perspectives on Decentralized... 4:15pm - 5:15pm

#310: BsUFA III and GDUFA III: Increasing FDA’s Authority to Enh... 9:15am - 10:15am

#327: New Approaches to Inspections 11:15am - 12:15pm

#348: Research and Innovation to Enhance Patient Access to Topic... 2:00pm - 3:00pm

#370: Where Are we Really on Data Interoperability? 4:15pm - 5:15pm

#311: Ahead of Analyses: Planning, Designing, and Pre-Specifying... 9:15am - 10:15am

#329: Complex Innovative Design: What’s in Name? A Global Perspe... 11:15am - 12:15pm

#350: The Transformation of Quality Assurance: The Roadmap 2:00pm - 3:00pm

#369: Approaches to Addressing Diversity and Inclusion in Clinic... 4:15pm - 5:15pm

#313: China Town Hall 9:15am - 10:15am

#323: Remote GMP Assessments, Inspections and Audits : Here to S... 11:00am - 12:00pm

#349: The Power and Uncertainty of Data: How it Can be Used to D... 2:00pm - 3:00pm

#372: Accelerating Innovation Through Investing 4:15pm - 5:15pm

#309: Pharmacovigilance Quality: Key Considerations 9:15am - 10:15am

#326: China’s Biopharma Innovation Landscape and Trends 11:15am - 12:15pm

#352: FDA Rare Disease Town Hall 2:00pm - 3:00pm

#375: The Global Impact of ORBIS: Case Studies and Perspectives 4:15pm - 5:15pm

#334 RT: Round Table Discussion: The Value of Medical Writing: T... 12:30pm - 1:30pm

#355 RT: Round Table Discussion: Mission-Driven Research Partner... 3:00pm - 4:00pm

#335 RT: Round Table Discussion: Value of Patient Experience Dat... 12:30pm - 1:30pm

#356 RT: Round Table Discussion: Planning for the Worst: Approac... 3:00pm - 4:00pm

#303: Grappling with Uncertainty: Pediatric Gene Therapy Trials... 9:00am - 10:00am

#322: Risky Business – The Sequel: Successfully Manage Program-L... 11:00am - 12:00pm

#344: Managing Up and Managing Down: Developing and Advocating f... 1:45pm - 2:45pm

#360 CH: Considerations for Esta... 3:15pm - 3:45pm

#379: Search Within: Maximize your Strengths and Possibilities 4:15pm - 5:15pm

#304: Transformation of the Data Manager to the Data Scientist 9:00am - 10:00am

#336 CH: Reviewing FDA's Draft G... 12:45pm - 1:15pm

#346: New Global Team: Building and Leading Remote Teams and Non... 1:45pm - 2:45pm

#361 CH: Separating the AI Hype... 3:15pm - 3:45pm

#377: Choosing the Most Convincing Clinical Endpoints in Cancer... 4:15pm - 5:15pm

#005 STU: Hashtag Your Way to a Job: How to Use... 12:45pm - 1:30pm

Coffee Service 8:00am - 10:00am

Coffee Break 11:00am - 11:30am

#404: Combination Product Safety: A Journey of Organizational Tr... 10:00am - 11:00am

#405: How the Heck do I Get this Digital Endpoint to Work in my... 10:00am - 11:00am

#406: The PCORnet Response to COVID-19: The Importance of Partne... 10:00am - 11:00am

#407: Methodologies Used to Aggregate Real-World Data and Clinic... 10:00am - 11:00am

#408: Writing at Lightspeed: Optimizing Submission Dossiers in T... 10:00am - 11:00am

#411: FDA Oncology Center of Excellence’s Real-Time Oncology Rev... 10:00am - 11:00am

#413: Where Next? Targeting Value Assessment and Contracting Opt... 10:00am - 11:00am

#415: EMA-FDA Question Time 10:00am - 11:00am

#416: FDA Town Hall 11:30am - 12:30pm

#409: How to Build and Support a Culture that Values Critical Th... 10:00am - 11:00am

#412: Novel Visualization Tools for Safety Assessment: An Initia... 10:00am - 11:00am

#410: Addressing Gaps in the Use of Real-World Evidence for Regu... 10:00am - 11:00am

#402 RT: Round Table Discussion: Reimbursement, Compensation, an... 9:00am - 10:00am

#403 CH: Who Should Be in the Ro... 9:15am - 9:45am

#414: Optimizing the Pharma Workforce for Trial Success in the D... 10:00am - 11:00am

#007 STU: It’s About the Journey Not the Destina... 9:00am - 9:45am