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Tuesday, June 20

10:30am CDT

#217: Update from CBER: Advancing the Development of Complex Biologic Products S404a
#220: Cardiac Safety S401bc #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 #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 #226: Accelerating Drug Development Through Innovation S502ab #227: At the Cornerstone of Wearable Technology and Patient-Focused Clinical Trial Endpoints S405b #229: Outcomes Standardization: An Imperative to Value Assessments N426c

2:00pm CDT

4:00pm CDT

#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