Agenda

Day 1 Feb 05, 2017

10:00 AM — 5:00 PM

Regulatory Content and Submissions Primer

Day 2 Feb 06, 2017

8:30 AM — 12:00 PM

Course 1: Global Identification of Medicinal Products (IDMP)

8:30 AM — 12:00 PM

Course 3: Achieving Regulatory Operations Excellence Through Outsourcing

12:45 PM — 1:00 PM

Navigate the DIA Global App

1:00 PM — 1:25 PM

Welcome and Opening Remarks

1:25 PM — 2:00 PM

Keynote Address: Perspective on PDUFA VI and the Strategic Vision for CDER Going into the Next PDUFA Cycle

2:00 PM — 3:30 PM

Plenary Session 1: FDA - PDUFA V Update

3:30 PM — 4:00 PM

Refreshments, Exhibits, and Networking Break

4:00 PM — 5:30 PM

Plenary Session 2: Other Regions Update

5:30 PM — 6:30 PM

Networking Reception

Day 3 Feb 07, 2017

7:30 AM — 8:30 AM

Registration, Continental Breakfast, and Exhibits

8:30 AM — 10:00 AM

Session 1: FDA Data Standards and Regulatory Compliance Update

10:00 AM — 10:30 AM

Refreshments, Exhibits, and Networking Break

10:30 AM — 12:00 PM

Session 2 Track 1: Business Impacts to IDMP

10:30 AM — 12:00 PM

Session 2 Track 2: Regulatory Analytics

10:30 AM — 12:00 PM

Session 2 Track 3: EDMS in the 21st Century, Better, Broader, More Flexible

10:30 AM — 12:00 PM

Session 2 Track 4: Ad/Promo

12:00 PM — 1:30 PM

Luncheon, Exhibits, and Networking

1:30 PM — 3:00 PM

Session 3 Track 1: What is RIM?

1:30 PM — 3:00 PM

Session 3 Track 2: Master Data Managment and Business - Where the Two Meet

1:30 PM — 3:00 PM

Session 3 Track 3: eTMF Interchange: The Cross-Roads Between Sponsor, CRO, and Vendors

1:30 PM — 3:00 PM

Session 3 Track 4: The Future of Electronic Submissions

3:00 PM — 3:30 PM

Refreshments, Exhibits, and Networking Break

3:30 PM — 5:00 PM

Session 4 Track 1: Regulatory Thought Leadership on the Industry-Wide Scale

3:30 PM — 5:00 PM

Session 4 Track 2: Use of Regulatory Data

3:30 PM — 5:00 PM

Session 4 Track 3: Digital Drivers: Reinventing and Accelerating Clinical Trials

3:30 PM — 5:00 PM

Session 4 Track 4: Publishing Pet Peeves and Practical Pointers

5:30 PM — 7:30 PM

Dinner on the Town: Wait, Wait, Don't Tell Me! Your Regulatory War Stories

Day 4 Feb 08, 2017

7:30 AM — 8:30 AM

Registration, Continental Breakfast, and Exhibits

8:30 AM — 10:00 AM

Session 5 Track 1: Registration Management

8:30 AM — 10:00 AM

Session 5 Track 2: IDMP Technology Focus

8:30 AM — 10:00 AM

Session 5 Track 3: Managing eTMF System Access: How SAFE-BioPharma Certified Credentials Enable Secure Identity Management

8:30 AM — 10:00 AM

Session 5 Track 4: Following the Sun: Regulatory Ops in Global Organization

10:00 AM — 10:30 AM

Refreshments, Exhibits, and Networking Break

10:30 AM — 12:00 PM

Session 6 Track 1: Save $60 Million – The Easy Way

10:30 AM — 12:00 PM

Session 6 Track 2: Structured Content Management

10:30 AM — 12:00 PM

Session 6 Track 3: Leverage Technology for a Seamless Process Between Collaboration and Official Repositories

10:30 AM — 12:00 PM

Session 6 Track 4: IND eCTDs: Transition from FDA Appreciating to Requiring eCTD INDs

12:00 PM — 1:30 PM

Luncheon, Exhibits, and Networking

1:30 PM — 3:00 PM

Session 7: FDA Electronic Submissions Update

3:00 PM — 3:15 PM

Refreshments and Networking Break

3:15 PM — 4:45 PM

Closing Plenary: "Ask the FDA"

4:45 PM — 5:00 PM

Closing Remarks

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