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 #119: ‘Target’ing Pediatric Oncology Development: New Global Pediatric Considerations Under FDARA 2017 Room 204AB

2:00pm EDT

#135: On the Soapbox: Right to Try Room 157AB

3:00pm EDT

#152: FDA Expectations for Demonstration of Interchangeability Room 206AB #150: TFDA Town Hall Room 208 #151: Using Real World Evidence for Regulatory Support: Time to Embrace the Future Room 205AB

8:00am EDT

#210: Artificial Intelligence: The Future of Regulatory Affairs Room 206AB #211: Update on Collaboration and Trends in Global Companion Diagnostics Room 208 #212: Global Regulatory Strategies for Biosimilars Room 204AB #213: 2018 Policy Mash-Up: New Shifts in the Healthcare Market and What They May Mean for Patients and the Biopharma Industry Room 205AB

10:30am EDT

#237: Expanded Access: Where Are We Now? Room 206AB #238: The European Medical Devices Regulation and MDUFA IV: One Year On - Is It Any Clearer? Room 204AB #239: Generic Drug Town Hall Room 205AB

2:00pm EDT

#263: Navigating the Regulatory Landscape of Drug-Device Combination Products Room 204AB #264: Global Development Using Expedited Pathways in Established and Emerging Markets Room 206AB

4:15pm EDT

#288: Is It Time to Change the Content and Format of Labeling? Room 205AB #289: Electronic Submissions Demystified Room 204AB #290: Priority Review Vouchers: Here to Stay and Worth the Effort? Room 206AB

8:00am EDT

#312: Harmonizing Regulatory Science Through the International Council for Harmonisation (ICH) Room 206AB #313: Global Rare Disease Town Hall Room 205AB #314: What Can We Say About Combination Products? Labeling, Advertising and Promotion of Combination Products Room 204AB

10:30am EDT

#340: Harmonization Beyond ICH Room 206AB #341: New FDA Draft Guidance on Part 11 in Clinical Investigations Room 204AB #342: Sex Considerations in the FDA Drug Review Pipeline: The Where, When, and How Room 205C

2:00pm EDT

#372: AdPromo: Assessing Risk in the Current Regulatory Environment Room 206AB #370: Clinical Outcome Assessments (COA) Endpoints for Use in Rare and Ultra-Rare Disease Clinical Trials Room 204AB #371: What's New in Health Canada: Updates and New Endeavors Room 205C #373: PMDA Town Hall Room 205AB

4:00pm EDT

#394: Update on BREXIT Room 205AB #395: PDUFA VI: Improving Transparency and Accountability of Electronic Submission and Data Standards Activities Room 205C

9:00am EDT

#411: Regulatory and Industry Perspectives on the Common Protocol Template Room 253C #412: Metrics and Meaning: Evolving Metrics in Generic Drug Application Review and Communications to Improve ANDA Submission Planning and Approvability Room 257AB