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Regulatory Submissions, Information, and Document Management Forum
Agenda
Day 1
Day 2
- — Course 1: Global Identification of Medicinal Products (IDMP)
- — Course 3: Achieving Regulatory Operations Excellence Through Outsourcing
- — Navigate the DIA Global App
- — Welcome and Opening Remarks
- — Keynote Address: Perspective on PDUFA VI and the Strategic Vision for CDER Going into the Next PDUFA Cycle
- — Plenary Session 1: FDA - PDUFA V Update
- — Refreshments, Exhibits, and Networking Break
- — Plenary Session 2: Other Regions Update
- — Networking Reception
Day 3
- — Registration, Continental Breakfast, and Exhibits
- — Session 1: FDA Data Standards and Regulatory Compliance Update
- — Refreshments, Exhibits, and Networking Break
- — Session 2 Track 1: Business Impacts to IDMP
- — Session 2 Track 2: Regulatory Analytics
- — Session 2 Track 3: EDMS in the 21st Century, Better, Broader, More Flexible
- — Session 2 Track 4: Ad/Promo
- — Luncheon, Exhibits, and Networking
- — Session 3 Track 1: What is RIM?
- — Session 3 Track 2: Master Data Managment and Business - Where the Two Meet
- — Session 3 Track 3: eTMF Interchange: The Cross-Roads Between Sponsor, CRO, and Vendors
- — Session 3 Track 4: The Future of Electronic Submissions
- — Refreshments, Exhibits, and Networking Break
- — Session 4 Track 1: Regulatory Thought Leadership on the Industry-Wide Scale
- — Session 4 Track 2: Use of Regulatory Data
- — Session 4 Track 3: Digital Drivers: Reinventing and Accelerating Clinical Trials
- — Session 4 Track 4: Publishing Pet Peeves and Practical Pointers
- — Dinner on the Town: Wait, Wait, Don't Tell Me! Your Regulatory War Stories
Day 4
- — Registration, Continental Breakfast, and Exhibits
- — Session 5 Track 1: Registration Management
- — Session 5 Track 2: IDMP Technology Focus
- — Session 5 Track 3: Managing eTMF System Access: How SAFE-BioPharma Certified Credentials Enable Secure Identity Management
- — Session 5 Track 4: Following the Sun: Regulatory Ops in Global Organization
- — Refreshments, Exhibits, and Networking Break
- — Session 6 Track 1: Save $60 Million – The Easy Way
- — Session 6 Track 2: Structured Content Management
- — Session 6 Track 3: Leverage Technology for a Seamless Process Between Collaboration and Official Repositories
- — Session 6 Track 4: IND eCTDs: Transition from FDA Appreciating to Requiring eCTD INDs
- — Luncheon, Exhibits, and Networking
- — Session 7: FDA Electronic Submissions Update
- — Refreshments and Networking Break
- — Closing Plenary: "Ask the FDA"
- — Closing Remarks