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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