Agenda

Day 1 Sep 21, 2014

1:00 PM — 4:30 PM

Regulatory Information Management (RIM)

Day 2 Sep 22, 2014

7:00 AM — 8:00 AM

Registration and Continental Breakfast

8:00 AM — 8:30 AM

Welcome and Opening Remarks

8:30 AM — 10:00 AM

Plenary Session 1 - FDA Update

10:00 AM — 10:30 AM

Refreshment Break/Networking/Exhibits

10:30 AM — 12:00 PM

Plenary Session 2 - Other Regions Update

12:00 PM — 1:30 PM

Lunch/Exhibits

1:30 PM — 3:00 PM

Session 1 Track 1 - Leveraging the eCTD for Global Efficiency

1:30 PM — 3:00 PM

Session 1 Track 2 - Collaboration & Integration: Facilitating Internal - External Interactions and Processes

1:30 PM — 3:00 PM

Session 1 Track 3 - Creating a Sustainable Global Clinical Research Collaborative Network

3:00 PM — 3:30 PM

Refreshment Break/Networking/Exhibits

3:30 PM — 5:00 PM

Session 2 Track 1 - Organizational Transformation of Enterprise Systems and Standards

3:30 PM — 5:00 PM

Session 2 Track 2 - Outlining the Pathway to a Paperless Trial

3:30 PM — 5:00 PM

Session 2 Track 3 - Establishing Processes and Controls to Ensure an Inspection-Ready TMF Every Day

5:00 PM — 6:00 PM

Networking Reception

Day 3 Sep 23, 2014

7:30 AM — 8:30 AM

Registration and Continental Breakfast

8:30 AM — 10:30 AM

Session 3 Track 1 - Managing the Practical Impacts of Mergers & Acquisitions: Approaches to Process and Systems Integration in Clinical, Regulatory, and Quality

8:30 AM — 10:00 AM

Session 3 Track 2 - Case Studies: Using the ‘Cloud’ to Support Electronic Document Management (EDM), Electronic Regulatory Submissions (ERS) and Regulatory Information Management (RIM) Activities

8:30 AM — 10:00 AM

Session 3 Track 3 - e/TMF Reference Models: Interactive Colossus

10:00 AM — 10:30 AM

Refreshment Break/Networking/Exhibits

10:30 AM — 12:00 PM

Session 4 Track 1 - Managing and Developing Regulatory Submission Operations

10:30 AM — 12:00 PM

Session 4 Track 2 - Why Would Anyone Adopt an eTMF?

10:30 AM — 12:00 PM

Session 4 Track 3 - Progression and Utilization of the DIA EDM Harmonization Effort (Reference Models)

12:00 PM — 1:30 PM

Lunch/Exhibits

1:30 PM — 3:00 PM

Session 5 Track 1 - IDMP Part 1: Are you ready for IDMP? The Technical Perspective

1:30 PM — 3:00 PM

Session 5 Track 3 - Identities & Signatures? What to Consider When Going Electronic

3:00 PM — 3:30 PM

Refreshment Break/Networking

3:30 PM — 5:00 PM

Session 6 Track 1 - IDMP Part 2: Are you ready for IDMP? The Business Perspective

3:30 PM — 5:00 PM

Session 6 Track 2 - Implementation of Regulatory Information Submission Standards (IRISS)

3:30 PM — 5:00 PM

Session 6 Track 3 - Successful Transformation from Start to Finish

Day 4 Sep 24, 2014

8:30 AM — 10:00 AM

Session 7 Track 1 - Best Practices for eCTD Submission Development: Upstream and Downstream Activities that Impact the Submission Date

8:30 AM — 10:00 AM

Session 7 Track 2 - eCTD v4 / RPS; Are you preparing for the transition to eCTD v4?

8:30 AM — 10:00 AM

Session 7 Track 3 - Working with Regional Affiliates to Achieve Compliance Globally

10:00 AM — 10:30 AM

Refreshment Break/Networking

10:30 AM — 12:00 PM

Closing Plenary - "Ask the Regulators" Session

12:00 PM — 12:15 PM

Closing Remarks

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EDM and ERS 2014

Agenda

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