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Wednesday, June 21
 

7:00am

8:00am

9:30am

9:45am

10:30am

#331: Conversations that Matter: How do Pharmacovigilance Professionals wish to Engage with Statisticians and Vice Versa? S400 Concourse #308: Quantified Self Tracking N227b #309: Big Data: Combining Registries and Legacy Clinical Trial Databases S505ab #310: New Site Paradigm: Just in Time Sites N229 #311: Next Generation Patient Recruitment: Part 2 of 2 S501abc #312: CRISPR: Regulatory Challenges in the Gene Editing Revolution N228 #313: New Frontiers in Pharmaceutical Manufacturing S502ab #314: Digital Channels and Artificial Intelligence in Medical Information and Communications S401d #315: How to Engage Patients Within Medical Affairs S403ab #316: Quantitative Metrics to Capture the Value of Patient Engagement N426a #317: Evolution of Novel Registration Endpoints as Diseases Become Chronic S404bc #318: IMEDS: A Public-Private Partnership to Facilitate Real World Evidence Generation Based on the FDA's Sentinel System S404a #319: A New Age for Physician and Patient Labeling: Recommendations for Innovative Change in How We Communicate S404d #320: The Brave New World: The Ongoing Globalization of Pharmacovigilance N226 #321: Engagement, Education, Networks, Media, and Societies in Rare Diseases: The MUST Haves S503ab #322: Is the Future Bright for Treatment of Neurodegenerative Diseases? S504abc #323: Effective Collaborations: Navigating the Grey Space N426b #324: Keys to Effective Product Launch Preparation N426c #325: Leading in the Midst of Ambiguity S401bc #326: Optimizing Early Clinical Strategies to Support Breakthrough Therapy Designation S401a #327: Multiregional Clinical Trials and the ICH E17 S402ab #328: Real-World Data to Real World Evidence for Assessing Efficacy and Effectiveness N230b #329: Measuring and Advancing the Clinical Quality Management System S405a #330: Managing Acceleration and Quality In Product Development S405b

10:45am

11:15am

11:30am

12:00pm

12:45pm

1:00pm

1:30pm

2:00pm

#357: Biosimilars and Generics: Access Versus Innovation S405b #359: Cultural Diversity Aisle 300/400 #337: Big Data: Management and Analytics N426a #338: Risk-Based Monitoring: Convergence of Technology, Processes, and People N226 #339: Off-Label Communications to Health Care Providers and Consumers N229 #340: Digital Innovations for Medical Information Contact Centers S401a #341: EMA Policy 0070: A Game Changer for Industry N227b #342: Adoption and Implementation of Digital Platforms to Further Patient Interactions N426c #343: Expanded Access and Compassionate Use N230b #344: Minding the Gaps: Using Totality of Evidence in the Clinical and CMC Contexts to Support Regulatory Approval S404a #345: Global Perspective on ICH: Part 1 of 2 N228 #346: Understanding the New Common Rule and Its Impact to Industry N426b #347: Integrated Life Cycle Approaches to Benefit -Risk Assessment, Communication, and Evaluation S401d #348: Exploring the Evolution of Signal Detection S402ab #349: Pharmacovigilance 2.0: Redesigning for the Future S403ab #350: Innovative Designs and Statistical Approaches for Small Trials: Rare Disease or Pediatric Indications S502ab #351: Pregnancy and Lactation Labeling Rule: Unique Challenges to Meet Requirements S501abc #352: Collaborative Efforts to Accelerate Rare Disease Research and Development S504abc #353: What Do the Experts Believe? Translating Expert Knowledge and Judgment Into a Quantitative Belief Distribution S401bc #354: Experimental Studies: New Approaches to Study Designs to Facilitate Early Phase Decision Making S405a #355: FDA, NIH, and TransCelerate Collaborate to Accelerate Drug Development Through Protocol Harmonization S404bc #356: Value-Based Conversations with Payers: Issues, Opportunities, and Barriers S503ab #358: Life Cycle Management: ICH Q12 S404d

2:45pm

3:00pm

3:15pm

4:00pm

DIA Medical Writing Community Round Table Discussion: EMA Policy 0070:A Game Changer for Industry Community Corner #373: FDA–Health Canada Regulatory Cooperation Council Town Hall S401d #363: EHRs/eSource and Emerging Data Streams N230b #364: Risk-Based Monitoring: Convergence of Technology, Processes, and People: Panel Discussion N226 #365: Next Generation Predictive Analytics S503ab #366: Are We Ready for Telemedicine-Powered Clinical Trials? S504abc #367: Writing of Layperson Summaries of Clinical Trial Results According to the EU: Regulation and Its Impact on Global Pharmaceutical Activities S502ab #368: FDA Update on Prescription Drug Promotion N227b #369: How Is Digital Patient Engagement Impacting Trial Participation? S404a #370: Lessons Learned from the Sarepta Exondys 51 Approval S404bc #371: Global and Regional Collaboration Initiatives: Challenges, Opportunities, and Case Studies S403ab #372: The Reauthorization of GDUFA and Its Impact on Sponsor and Regulator N229 #374: Global Perspective on ICH: Part 2 of 2 N228 #375: Automation and Innovation in Clinical Trial Safety Assessment S402ab #376: Changing Environments Within Pharmacovigilance S404d #377: Increasing Participation in Clinical Trials Among Under-Represented Populations S505ab #378: Looking to the Future for EU Pediatric Investigation Plans S501abc #379: The Art of Negotiation: Preparing Yourself and Your Team for Their Seat at the Table S401bc #380: Effective Portfolio Management and How to Ensure You Get the Value Out of the Decisions Made N426a #381: Maximizing Success in Partner Collaborations N426b #382: Patient-Relevant, Fit-For-Purpose Endpoints: If You Can Believe It, You Can Achieve It S405a #383: Safety Issues in First-in-Human Studies S405b #384: The Increasing Role for Big Data for Late Phase Drug and Postapproval Purposes S401a #385: Patient-Centric Development Assessment N426c

5:30pm