DIA 2020 Virtual Global Annual Meeting has ended

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DIA 2020 Virtual Global Annual Meeting

8:00am EDT

SC35: #35: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development TBD

9:00am EDT

SC21: #21: Real World Evidence: The Evolving Landscape of Regulators, Data and Integrated Use TBD SC25: #25: Regulatory Requirements for IND/NDA Procedures in China TBD

1:30pm EDT

SC34: #34: Preparing for a US FDA Advisory Committee Meeting TBD

11:00am EDT

#107 L: Patients First! How FDA is Making Patients a Priority TBD #109 L: International Convergence on Regulatory Review and HTA: Getting the “Universal Evidence” We Need for Decisions on Innovation TBD

3:30pm EDT

#133 L: FDA’s Considerations on Benefit-Risk Assessment for Human Drug Review TBD

9:30am EDT

#210 SL: Clinical Electronic Structured Harmonized Protocol (CeSHarP): ICH M11 - Status Update TBD #214 L: GCP Quality and Compliance: The Regulators’ Perspective TBD

2:00pm EDT

#236 L: FDA Data Standards Update TBD

4:00pm EDT

#246 SL: FDA Pre-Market Safety Assessment Program TBD

8:00am EDT

#304 L: Strategic Directions from Global Medicines Regulators: The ICMRA Statement on Combatting Antimicrobial Resistance TBD #304.1 L: ICH 30th Anniversary: Achievements and Future Prospects TBD #306 L: Defining the Treatment Effect of Interest in Regulatory Submissions: Estimands and ICH E9R1 Final Guidance TBD

9:30am EDT

#311 L: ICH 30th Anniversary Series: Advancing Pharmaceutical Safety TBD

2:00pm EDT

#334 L: Best Practices for Virtual Meetings with FDA! TBD

4:00pm EDT

#339 SL: The Development of Novel Digital Endpoints TBD

8:00am EDT

#401 L: Digital Risk Minimization: How Can We Advance Adoption? TBD #402 L: FDA Perspectives on Modernization of Clinical Trials: Real World Evidence, Decentralized Clinical Trials, and Digital Health Technologies TBD #404 L: Incorporating Patient Input into Medical Product Development and the US Food and Drug Administration’s Decision-Making TBD

9:30am EDT

#415 SL: Opportunities and Challenges for Real World Data and Real World Evidence: Dive Into the Details TBD

11:30am EDT

#422 L: How the FDA’s MyStudies Platform is Accelerating the Use of Digital Technology in Clinical Research and Clinical Trials TBD

5:00pm EDT

#504.1 OD: ON DEMAND - The Opioid Epidemic: Top Ten Lessons in Regulatory Science TBD #514 OD: ON DEMAND - Single-Sponsor Master Protocol: Development and Regulatory Experience with a Complex Innovative Design (CID) TBD #535 OD: ON DEMAND - Developing Products by the FDA Animal Rule: Working with FDA and Real World Challenges TBD #547 OD: ON DEMAND - New Drugs Regulatory Program Modernization TBD #550 OD: ON DEMAND - PMDA Town Hall: The Path of a New Chief Executive Since His Appointment TBD #551 OD: ON DEMAND - Advancing Clinical Trial Innovation Through Model-Informed Drug Development TBD #552 OD: ON DEMAND - Regulatory Barriers to Entry for Biosimilars TBD #554 OD: ON DEMAND - Strengthening Food and Drug Regulatory Systems Abroad: Recommendations from the FDA-Commissioned NASEM Report TBD #555 OD: ON DEMAND - Updates of Drug Evaluation and Inspection in China TBD #549 OD: ON DEMAND - Translating Frequently Collected Patient Experience Data into Meaningful Trial Endpoints TBD #556 OD: ON DEMAND - Demystifying Global Device Requirements: High Level Comparison of Current Expectations TBD