Agenda

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Day 1 Feb 09, 2023

10:00 AM — 2:00 PM

Short Course: The Future of Documents: Deep-Dive into Structured Content

Day 2 Feb 10, 2023

10:00 AM — 2:00 PM

Short Course: On the Road to an EU Filing: Getting Familiar with Critical EMA IT Systems

Day 3 Feb 12, 2023

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 4 Feb 13, 2023

11:30 AM — 5:25 PM

Forum Registration

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

2:00 PM — 2:45 PM

Refreshment and Networking Break in the Exhibit Hall

2:15 PM — 2:45 PM

Sponsored Session: Case Study hosted by Court Square Group / Adlib Software: The “Easy” Button for eTMF Classification: Using AI to Streamline Classification of Clinical Trial Documents

2:45 PM — 4:00 PM

Session 2: FDA Plenary: PDUFA VII Information Technology and Bioinformatics

4:10 PM — 5:00 PM

Session 3: FDA: Ask the Regulators

5:00 PM — 6:00 PM

Networking Reception in the Exhibit Hall

Day 5 Feb 14, 2023

7:30 AM — 8:00 AM

Networking Breakfast in the Exhibit Hall

7:30 AM — 5:30 PM

Registration

8:00 AM — 9:15 AM

Session 4: FDA Plenary: Electronic Submissions Update

9:25 AM — 10:40 AM

Session 5: International Regulatory Authority Updates

10:40 AM — 11:15 PM

Refreshment and Networking Break in the Exhibit Hall

10:45 AM — 11:15 AM

Sponsored Session: Case Study hosted by Calyx: A Guide to Bringing Regulatory Publishing In-House – Key questions to ask

11:15 AM — 12:30 PM

Session 6 Track 1: Driving Performance from RIM

11:15 AM — 12:30 PM

Session 6 Track 2: Optimizing Regulatory Operations Through the Application of Advanced Technologies

11:15 AM — 12:30 PM

Session 6 Track 3: Advancing Inspection Readiness Through Data Driven Planning and Continuous Process Improvement

11:15 AM — 12:30 PM

Session 6 Track 4: Submissions Are Data – Changing Formats and Improving the Submission Process

12:30 PM — 2:00 PM

Networking Luncheon in the Exhibit Hall

12:45 PM — 1:45 PM

Sponsored Lunch and Learn Session Hosted by Genpact: How to Maximize Business Value and Improve Health Outcomes with RIM Investments (Invite Only)

2:00 PM — 3:15 PM

Session 7 Track 1: New Developments in RIM Reference Model

2:00 PM — 3:15 PM

Session 7 Track 2: Is it Time to Streamline Your Processes with Structured Content Management?

2:00 PM — 3:15 PM

Session 7 Track 3: Regulatory Submissions: Special Requirements in Europe and China

2:00 PM — 3:15 PM

Session 7 Track 4: Pairing Strategic Vision With Innovation To Support Regulatory Processes

3:15 PM — 4:15 PM

Refreshment and Networking Break in the Exhibit Hall

3:30 PM — 4:15 PM

Sponsored Session: Case Study hosted by IQVIA: Reduce Time, Cost, and Risk, from Drug Discovery Through Post-Registration

4:15 PM — 5:30 PM

Session 8 Track 1: IDMP Ontology: Semantic Interoperability Throughout the Entire Medicinal Product Lifecycle

4:15 PM — 5:30 PM

Session 8 Track 2: Business Benefits and Insights Gained from Regulatory Intelligent Automation Implementations

4:15 PM — 5:30 PM

Session 8 Track 3: The Evolution of Documents to Digital – New Solutions Using Emerging Technologies

4:15 PM — 5:30 PM

Session 8 Track 4: Submission Quality

5:30 PM — 6:00 PM

DIA EDM Structured Submission Reference Model Kick-off

Day 6 Feb 15, 2023

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: Regulatory 3.0 - A Data Driven Perspective

8:30 AM — 9:45 AM

Session 9 Track 2: Lessons Learned in Advancing Data Based RIM and the Practical Application of Governance Frameworks

8:30 AM — 9:45 AM

Session 9 Track 3: Using Automation to Replace Manual Documentation Processing, Realize Resource Efficiencies, and Gain Valuable Insights Into Your Data

8:30 AM — 9:45 AM

Session 9 Track 4: Dynamic Submission Planning - Plan, Replan, and Execute

9:45 AM — 10:30 AM

Refreshment and Networking Break in the Exhibit Hall

10:00 AM — 10:30 AM

Sponsored Session: Case Study hosted by ArisGlobal: Revolutionize Management of Global Lifecycle Submissions

10:30 AM — 11:45 AM

Session 10 Track 1: “Good RIM” – Key Considerations on Establishing Comprehensive Data Readiness, Governance & Quality Management

10:30 AM — 11:45 AM

Session 10 Track 2: Along the Path of Drug Approval; A Hodgepodge of IDMP, EMA Support for SMEs, and ICH M11 CeSHarP

10:30 AM — 11:45 AM

Session 10 Track 3: How Innovative Collaboration Supports Compliance Across the Regulatory Ecosystem

10:30 AM — 11:45 AM

Session 10 Track 4: Transformation in Submission Management: Current Activities and Future Trends

11:45 AM — 1:15 PM

Networking Luncheon in the Exhibit Hall

1:15 PM — 2:00 PM

Session 11: FDA - Ask the Regulators

2:00 PM — 2:15 PM

Closing Remarks

2:15 PM — 2:15 PM

Forum Adjourns

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