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Level: Intermediate [clear filter]
Monday, June 19
 

11:00am

 
Tuesday, June 20
 

10:30am

2:00pm

4:00pm

#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 #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 #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
 
Wednesday, June 21
 

10:30am

2:00pm

4:00pm

#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 #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
 
Thursday, June 22
 

10:45am