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 SC26: #26: “Has it Happened Already?” Questions of Precedent from which Regulatory Intelligence Can Save You TBD

1:30pm EDT

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

11:00am EDT

#105 SL: To Shape the Future of Patient Labeling Across Regions TBD #109 L: International Convergence on Regulatory Review and HTA: Getting the “Universal Evidence” We Need for Decisions on Innovation TBD

1:30pm EDT

#123 L: Is Your App a Drug, a Device, or Something Else Entirely? TBD #124 SL: Gene Therapy Manufacturing: How Can Innovation Help Overcome This Anticipated Hurdle? TBD

3:30pm EDT

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

8:00am EDT

#203 L: ICH 30th Anniversary Series: The Role of Multidisciplinary Topics TBD #205 SL: Using Artificial Intelligence to Inform Regulatory and Development Strategies TBD

9:30am EDT

#210 SL: Clinical Electronic Structured Harmonized Protocol (CeSHarP): ICH M11 - Status Update TBD #215 L: ACTIV: A Public-Private Partnership to Speed COVID-19 Therapies and Vaccines TBD

11:30am EDT

#225 L: Accelerated Approval and Emerging Surrogate Endpoints TBD

2:00pm EDT

#236 L: FDA Data Standards Update TBD #238 SL: Utilizing Cloud-Based Platforms in Regulatory Contexts 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

9:30am EDT

#312 L: Pediatric Development: Can Increasing Collaboration Lead to Fewer Unnecessary Trials? TBD

11:30am EDT

#320 L: Advanced Therapy Medicinal Products: Facilitating Individualized Gene Therapies and Cell-Based Therapeutics TBD

2:00pm EDT

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

8:00am EDT

#402 L: FDA Perspectives on Modernization of Clinical Trials: Real World Evidence, Decentralized Clinical Trials, and Digital Health Technologies TBD #406 SL: FDA-PAHO: Landscape Report of Regulatory Situation in the Americas TBD #405 L: Catalyzing the Integration of Digital Technologies in Healthcare Solutions TBD

10:30am EDT

#417 SL-CH: Information Overload: Best Practices to Manage Information and Remember Where the Information Is! 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 #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 #553 OD: ON DEMAND - What Makes Real World Data Trustworthy: A Focus on Design and Data 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