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Saturday, June 17
 

8:00am

 
Sunday, June 18
 

8:00am

8:30am

9:00am

10:30am

12:00pm

12:30pm

1:00pm

2:45pm

4:15pm

 
Monday, June 19
 

6:30am

7:00am

7:30am

8:30am

10:00am

10:15am

11:00am

#130: Career Opportunities in Transitions in Life Science S400 Concourse #106: Leveraging Big Data/ Real-World Data in Enabling Efficient and Data-Driven Clinical Research From Sponsor, Vendor and National Health System Perspective: Case Studies N229 #107: Leveraging Wearables and Sensors in Clinical Trials and mHealth S501abc #108: Artificial Intelligence/Machine Learning S502ab #109: Submission Dossiers: Communications Excellence to Drive Speed and Quality S503ab #110: Globalization of Medical Affairs Departments S504abc #111: Patient Engagement: 4 W's and an H N426a #112: Data Sharing: 2017 and Beyond N426b #113: We Can't Forget the Children in This Process N426c #114: PDUFA at 25: A Historical View of the Prescription Drug User Fee Agreement and a Look to the Future - PDUFA VI N228 #117: Postmarketing Safety Studies: Approaches and Regulatory Insights S401a #118: Counting on Safety S401d #119: Designing and Implementing a Robust Pharmacovigilance System for Vaccines S401bc #120: FDA Rare Disease Town Hall N227b #121: Effective Life Cycle Management S505ab #122: GBM AGILE: A Transformative Global Adaptive Platform Clinical Trial S404a #123: Calling All Angels to the Valley of Death S405b #124: Exploration of PK/PD in NDA Enabling or Early Proof of Concept Studies S402ab #125: Hybrid Study Designs: An Innovative Approach to Obtaining Valuable Information by Combining Existing Data with New Data Length S404bc #126: Breaking Down the Wall for FDA to Leverage Real World Data N226 #127: The Evolving International Landscape of FDA Inspections: Data Integrity Violations in Bioequivalence Studies in India S405a #128: Office of Pharmaceutical Quality Update: Innovative Approaches in Regulatory Assessment N230b #129: Engage and Exchange Student Forum Exhibit Hall #115: Update from the CFDA S403ab

11:45am

12:00pm

12:30pm

1:00pm

1:15pm

1:45pm

2:00pm

3:00pm

4:30pm

4:45pm

5:30pm

 
Tuesday, June 20
 

7:00am

8:00am

9:30am

9:45am

10:30am

#231: A Risk-Based Approach to Quality Management for RWE Studies S400 Concourse #217: Update from CBER: Advancing the Development of Complex Biologic Products S404a #218: ClinicalTrials.gov: Complying with Requirements in the Final Rule (42 CFR Part 11) and Impacts of 21st Century Cures Act S404bc #220: Cardiac Safety S401bc DIA Study Endpoints Community Round Table Discussion: Leveraging Wearables and Sensors in the Clinical Trials and mHealth Community Corner #208: Big Data: Regulatory Information N226 #209: Evolving Data Standards and Regulations N228 #210: The New Business Reality for the Medical Science Liaison Community S401d #211: Sharing the Burden N426b #212: Walking the Walk in Patient Focused Medicines Development: From Theory to Practice What Have We Learned? N426a #213: Regulatory Frameworks: How Can Regulators Facilitate Disruptive Innovation? S403ab #214: Recent Trends in Asian Regulations for Drug Development: What is Coming Next? N227b #215: The Evolving Model of Using Artificial Intelligence to Deliver Actionable Regulatory Intelligence S404d #216: International Collaboration in Times of Public Health Crisis N229 #219: Safety Evaluation: Transforming Information into Evidence S401a #221: Pharmacovigilance Inspections: Hot Topics and Proactive Approaches N230b #222: Serving the Patient Who Needs Early Access to Treatments and Achieving Meaningful Outcomes S505ab #223: Introduction to Rare Disease Studies: Challenges of Rare Disease From a Statistical, Protocol Development, and Operations Perspective S503ab #224: Success in Early CNS Drug Development: Getting Proof-of-Principle by Stacking the Deck with Biomarkers S504abc #225: So You Say You're an Extrovert: Being an Effective Leader when All You Really Want Is a Stage S501abc #226: Accelerating Drug Development Through Innovation S502ab #227: At the Cornerstone of Wearable Technology and Patient-Focused Clinical Trial Endpoints S405b #228: Master Protocols: New Approaches to Enrolling Hard-to-Find Subjects and Expediting Drug Development S405a #229: Outcomes Standardization: An Imperative to Value Assessments N426c #230: Global Harmonization: Mutual Recognition S402ab

10:45am

11:30am

12:00pm

12:45pm

1:00pm

1:15pm

1:30pm

2:00pm

#243: Data and Privacy Protection N426a #260: Comparative Effectiveness: State of the Art and Stakeholder Perspectives S405b #263: Mergers and Acquisitions: Due Diligence Considerations Exhibit Hall DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Pharmacovigilance Inspections: Hot Topics and Proactive Approaches Community Corner #240: Mobile Health: Participatory Research N426c #241: FDA Session: Electronic Submissions and Data N228 #242: Big Data: Current and Emerging Technologies N227b #244: New Trial Design Approaches: Including New Endpoints S501abc #245: Leveraging Wearables and Sensors in Clinical Trials: Case Studies S502ab #246: Medical Information and the Patient: Effective Communication and Handling of Requests S503ab #247: Best Practice for Advisory Committee Meeting Preparation S504abc #248: Building the Medical Strategy and Tactics S401a #249: Not Your Grandma's Patient Advocacy Group Anymore S402ab #250: If You See Something (About a Clinical Trial), Do You Say Something (to Your Doctor?) S401d #251: Defining the Science of Patient Input to Enhance Drug Development and Approval: Regulatory N226 #252: What’s New in Devices: European Medical Device Regulations and MDUFA IV S404a #253: Regulatory Challenges with Next Generation Sequencing S404bc #254: New Considerations in Benefit-Risk Management S403ab #255: Integrating the Patient's Voice Across the Development Program of Rare Diseases: Translation Into Meaningful Outcomes S505ab #256: Post-Trial Access: Ensuring Patient Access Across the Development Spectrum N230b #257: Strategic Planning Across Research Organizations N426b #258: Patient-Reported Outcomes (PROs): Hot Topics - Part 1 of 2 S404d #259: Novel Techniques for Improving Clinical Trial Subject Retention S405a #261: Comparison of Inspection Findings and Recommendations of Registration Trials Submitted in Support of Marketing Applications of New Drug Products to EMA and FDA N229 #262: Clinical Relevant Specifications: Leveraging Principles of QbD S401bc

2:45pm

3:00pm

3:25pm

4:00pm

#292: How eSource Solutions are Impacting Clinical Research Sites, Patients, Regulators and Drug and Device Companies S400 Concourse #268: FDA Session: Health IT at FDA N227b #272: Microbiome: Innovative Therapeutics, Challenges, and Opportunities S502ab #286: Audits and Agency Inspections of Risk-Based Monitored Studies: The Results Are In... S405b #291: Combination Products Exhibit Hall #269: Big Data: Genomics and Personalized Medicine N226 #270: Data Quality N426a #271: Next Generation Patient Recruitment: Part 1 of 2 S501abc #273: Creating Adaptive Contents for a Multichannel World S503ab #274: Effective Collaboration Between Sponsors and Medical Writing Vendors S403ab #275: Partnering with Patients: Virtual and Traditional Communities - When for What S401d #276: Defining the Science of Patient Input to Enhance Drug Development and Approval: Tools S402ab #277: The Reauthorization of BsUFA and its Impact on Both the Regulator and Industry N228 #278: PMDA Town Hall S404a #279: Brexit: Where Are We Now? S404bc #280: Developing Pharmacovigilance Policy Based on Impact S401bc #281: Integrating the Patient's Voice Across the Development Program of Rare Diseases: At the Table - Where to Sit? S505ab #282: Challenges and Issues in Early-Phase Oncology Trials S504abc #283: The Impact of Industry Consortia on Creating Collaborative Solutions to Drug Development Challenges: What Does the Future Hold? N426b #284: Use of Novel Trial Designs to Accelerate Decision Making: To 'P' No More S401a #285: What Question Are You Trying to Answer? The Use of Estimands, Potential Revisions to ICH E-9 and the Impact to Trial Design and Analysis S405a #287: Patient-Reported Outcomes (PROs): Hot Topics - Part 2 of 2 S404d #288: Breaking Down the Wall for Global Regulators to Leverage Real World Data N230b #289: Value and Access for Special Populations: From Access Restriction to Drug Mortgages N426c #290: Quality Metrics: The Carrot or the Stick? N229

4:45pm

5:30pm

 
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

 
Thursday, June 22
 

8:00am

9:00am

10:30am

10:45am