Agenda

Day 1 Feb 09, 2020

9:30 AM — 10:00 AM

Regulatory Content and Submission Primer Registration

10:00 AM — 5:00 PM

Regulatory Content and Submission Primer: Content from Authoring to Archive

Day 2 Feb 10, 2020

7:30 AM — 8:30 AM

Short Course Registration

8:30 AM — 12:00 PM

Short Course 1: Data at the Heart of Life Science Professionals: Instant Informed Decision-Making

8:30 AM — 12:00 PM

Short Course 2: Preparing and Submitting Standardized Study Data to FDA, Presented by FDA, CDER

11:00 AM — 5:00 PM

Forum Registration

12:40 PM — 1:00 PM

DIA Mobile App Tutorial

1:00 PM — 1:25 PM

Welcoming Remarks and Presentation of the Excellence in Service Award

1:25 PM — 2:00 PM

Session 1: Keynote Address: A New Passion to Life: Experiencing the Impact of Regulatory Submissions

2:00 PM — 2:45 PM

Refreshment and Networking Break in the Exhibit Hall

2:45 PM — 4:00 PM

Session 2: FDA Plenary

4:10 PM — 5:25 PM

Session 3: Artificial Intelligence Panel: Regulatory Affairs in the Age of Artificial Intelligence

5:25 PM — 6:30 PM

Networking Reception in the Exhibit Hall

5:45 PM — 6:30 PM

Speed Networking Hosted by the DIA Diversity in Life Sciences Community

Day 3 Feb 11, 2020

7:30 AM — 8:30 AM

Networking Breakfast in the Exhibit Hall

7:30 AM — 5:30 PM

Registration

8:30 AM — 9:45 AM

Session 4: FDA: Digital IND Safety Reporting

9:55 AM — 10:55 AM

Session 5: FDA - Ask the Regulators: Electronic Submissions and eCTD Panel

10:45 AM — 11:15 AM

Refreshment and Networking Break in the Exhibit Hall

11:15 AM — 12:30 PM

Session 10 - Concurrent Session

11:15 AM — 12:30 PM

Session 6 - Concurrent Session

11:15 AM — 12:30 PM

Session 6 Track 1: RIM Reference Model: 2019 Progress/Call for Engagement

11:15 AM — 12:30 PM

Session 6 Track 2: Put People and Data First to Make Your Process and Technology Work

11:15 AM — 12:30 PM

Session 6 Track 3: Inspection Readiness: TMF Data Quality and Completeness Progress

11:15 AM — 12:30 PM

Session 6 Track 4: Regional Adoption of eCTD, the Next Wave (China, Eurasia, Middle East)

11:15 AM — 12:30 PM

Session 7 - Concurrent Session

11:15 AM — 12:30 PM

Session 8 - Concurrent Session

11:15 AM — 12:30 PM

Session 9 - Concurrent Session

12:30 PM — 2:00 PM

Networking Luncheon in the Exhibit Hall

12:30 PM — 2:00 PM

Solution Showcase Theater

12:45 PM — 1:45 PM

Session 6 Track 1: RIM Reference Model: 2019 Progress/Call for Engagement Continued

2:00 PM — 3:15 PM

Session 7 Track 1&3: The Challenges and Benefits of Consolidating Multiple Legacy RIM Systems from Submission Publishing/Global Regulatory to Archival

2:00 PM — 3:15 PM

Session 7 Track 2: ICH M11 Clinical Electronic Structured Harmonized Protocol

2:00 PM — 3:15 PM

Session 7 Track 4: Strategies to Achieve Global Regulatory Operations Excellence

3:15 PM — 4:15 PM

Refreshment and Networking Break in the Exhibit Hall

4:15 PM — 5:30 PM

Session 8 Track 1: Incorporating Optimization Strategies for Managing the Processes Associated with End-to-End Labeling Operations and Drug/Device Combination Product Management

4:15 PM — 5:30 PM

Session 8 Track 2: Driving Process Optimization with Unified RIM

4:15 PM — 5:30 PM

Session 8 Track 3: Analytical Driven Trial Design

4:15 PM — 5:30 PM

Session 8 Track 4: The Value of Vendor Relationships

6:30 PM — 8:00 PM

Dinner on the Town

Day 4 Feb 12, 2020

7:30 AM — 8:30 AM

Networking Breakfast in the Exhibit Hall

7:30 AM — 2:00 PM

Registration

8:30 AM — 9:45 AM

Session 9 Track 1: Proven Techniques in Selecting and Implementing a Regulatory Information Management Solution that Fits Your Organization

8:30 AM — 9:45 AM

Session 9 Track 2: Harnessing Digital Technologies to Transform Life Sciences

8:30 AM — 9:45 AM

Session 9 Track 3: Deciphering 10 Years of Regulatory and Business Documents to Confirm to Information Technology ETL Requirements

8:30 AM — 9:45 AM

Session 9 Track 4: Quality and Speed to Submission - Process is the Key for These to Coexist!

9:45 AM — 10:30 AM

Refreshment and Networking Break in the Exhibit Hall

10:30 AM — 11:45 AM

Session 10 Track 1: IRISS Forum – Hot Topics

10:30 AM — 11:45 AM

Session 10 Track 2: The Future is Here: Modern Medical Regulatory Documents Enabled by Structure, Standards, and Content Reuse

10:30 AM — 11:45 AM

Session 10 Track 3: Maintaining Validation of Your Cloud Based Document Management Systems

10:30 AM — 11:45 AM

Session 10 Track 4: eCTD AdPromo Panel Discussion

11:45 AM — 1:15 PM

Networking Luncheon in the Exhibit Hall

1:15 PM — 2:00 PM

Session 11: FDA - Ask the Regulators: International Panel

2:00 PM — 2:15 PM

Closing Remarks

2:15 PM — 2:15 PM

Forum Adjourns

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