DIA 2018 Global Annual Meeting has ended

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DIA 2018 Global Annual Meeting

11:00am EDT

#118: How Can We Optimally Incorporate Real World Evidence into Regulatory Decision-Making? Room 205AB #120: FDA Innovation in Pharmaceutical Quality Assessment and Inspection Room 206AB #121: Use of Historical Information in Clinical Trial Design Room 256

3:00pm EDT

#151: Using Real World Evidence for Regulatory Support: Time to Embrace the Future Room 205AB

8:00am EDT

#201: Generic Drug Products: Comparison of Safety Profile With Branded Cousin Room 253AB #204: FDA Data Standards Update Room 209 #206: Incorporating Patient Input Into US Food and Drug Administration’s Medical Product Development and Regulatory Decision Making Room 151AB #211: Update on Collaboration and Trends in Global Companion Diagnostics Room 208

10:30am EDT

#226: Regulators’ Utilization of Real-World Data in Pharmacovigilance Activities Room 253AB #230: Common Data Model Harmonization for Evidence Generation Room 208 #233: The Patient's Assessment of the Patient-Focused Drug Development Meeting Initiatives Room 151AB #239: Generic Drug Town Hall Room 205AB

2:00pm EDT

#255: Use of Electronic Health Records (EHRs) as eSource in Clinical Investigations Room 208 #265: ICH M9 BCS-Based Biowaivers Room 253C

4:15pm EDT

#288: Is It Time to Change the Content and Format of Labeling? Room 205AB #278: Challenges and Opportunities in Data Access and Methodology Development for Post-Market Generic Drug Monitoring Room 252AB #286: Which Regulatory Project Management Staff at FDA Should You Engage With? When and How? Room 157AB #289: Electronic Submissions Demystified Room 204AB #291: ICH Q12: A Paradigm Changing Guidance for Post-Approval Changes? Room 208 #292: Complex Innovative Designs and Model-Informed Drug Development Related: PDUFA VI Pilot Programs Room 256

8:00am EDT

#309: Evolution and Harmonization of First-in-Human Guidelines Room 156ABC #312: Harmonizing Regulatory Science Through the International Council for Harmonisation (ICH) Room 206AB

10:30am EDT

#339: Determining Data Integrity: Decoding the Impact of Inspectional Observations Room 258AB #340: Harmonization Beyond ICH Room 206AB #341: New FDA Draft Guidance on Part 11 in Clinical Investigations Room 204AB

2:00pm EDT

#368: Predicting Future Generic Drug Competition: Powering Strategic Planning Using Quantitative Methods and Modeling Room 153ABC #369: Virtual Audits: Do They Achieve the Objective? Room 257AB #375: Statistical Challenges in Assessing Drugs’ Efficacy by Utilizing Biomarker Endpoints Room 256

4:00pm EDT

#393: Think Like a Regulator: Evaluating Trial Integrity Room 252AB #395: PDUFA VI: Improving Transparency and Accountability of Electronic Submission and Data Standards Activities Room 205C

9:00am EDT

#412: Metrics and Meaning: Evolving Metrics in Generic Drug Application Review and Communications to Improve ANDA Submission Planning and Approvability Room 257AB