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Regulatory Submissions, Information, and Document Management Forum

Don’t miss the latest conversations in Regulatory Informatics, EDM and TMF, and ERS! Join your industry colleagues and regulatory thought leaders by registering for the RSIDM Forum!

Agenda

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: Regulatory Informatics - Technology
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
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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On-Demand Content Preview Webinar

Harnessing the Power of Structured Content in Life Sciences: Practicalities, Challenges, and Opportunities in the Evolving Technology Landscape

Preconference Primer

Regulatory Content and Submission Primer: Content from Authoring to Archive

Preconference Short Courses

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

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

Additional Information

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Regulatory Submissions, Information, and Document Management Forum Resource Kit

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