Agenda

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Día 1 06 feb 2024

9:00 AM — 1:00 PM

Short Course: Driving IDMP Readiness and Compliance: Impact, Business Benefits, Strategies, and Application of AI

Día 2 08 feb 2024

10:00 AM — 2:00 PM

Short Course: Mapping Common Regulatory Data Standards to FHIR

Día 3 12 feb 2024

11:30 AM — 5:00 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 : Fostering Trustworthy and Responsible AI

2:00 PM — 2:45 PM

Refreshment and Networking Break in the Exhibit Hall

2:10 PM — 2:40 PM

Hosted Session: Case Study Spotlight hosted by Yseop: 3 Use Cases: GenAI for Medical Writing

2:45 PM — 3:30 PM

Session 2: FDA Plenary: Data and Technology Strategy

3:30 PM — 4:15 PM

Session 3: FDA Plenary: ICH M11 Protocol Template: A Global Solution for Global Drug Development

4:20 PM — 5:10 PM

Session 4: FDA: Ask the Regulators – Part 1

5:10 PM — 6:10 PM

Networking Reception in the Exhibit Hall

Día 4 13 feb 2024

7:45 AM — 8:15 AM

Networking Breakfast in the Exhibit Hall

7:45 AM — 5:00 PM

Registration

8:15 AM — 8:30 PM

Welcome to Day Two and DIA Community Update

8:30 AM — 9:45 AM

Session 5: FDA Plenary: Electronic Submissions Update

9:55 AM — 10:40 AM

Session 6: Ask the Regulators – Part 2

10:40 AM — 11:15 AM

Refreshment and Networking Break in the Exhibit Hall

10:45 AM — 11:15 AM

Hosted Session: Case Study Spotlight hosted by Glemser: How Automation Optimizes Quality and Time for ePI Conversions

11:15 AM — 12:30 PM

Session 7 Track 1: eCTD 4.0 - Paving the Path for Streamlined Global Drug Submissions

11:15 AM — 12:30 PM

Session 7 Track 2: Optimizing Affiliate Engagement: Learnings from a Landmark Affiliate Study

11:15 AM — 12:30 PM

Session 7 Track 3: The Future of Regulatory Submissions: Innovation of the Possible using a Non-disruptive Framework

11:15 AM — 12:30 PM

Session 7 Track 4: Achieving Operational Excellence through Master Data and Optimizing Digital Processes

12:30 PM — 1:45 PM

Networking Luncheon in the Exhibit Hall

1:45 PM — 3:00 PM

Session 8 Track 1: Submission Standards and Efficiencies

1:45 PM — 3:00 PM

Session 8 Track 2: The Value of Reference Models and Data Governance for RIM

1:45 PM — 3:00 PM

Session 8 Track 3: Modern Applications of Innovative Technologies in Regulatory Processes

1:45 PM — 3:00 PM

Session 8 Track 4: Achieving a Global Dossier: How Can Industry Encourage Convergence and Collaboration to Revolutionize Regulatory Review?

3:00 PM — 3:45 PM

Refreshment and Networking Break in the Exhibit Hall

3:10 PM — 3:40 PM

Hosted Session: Case Study Spotlight hosted by Astrix: Evolving a Sponsor RIM Organization – Supporting Regulatory Excellence leveraging COEs and centralized capabilities

3:45 PM — 5:00 PM

Session 9 Track 1: Shaping and Overseeing Regulatory Strategy, Operations, and Vendor Relationships

3:45 PM — 5:00 PM

Session 9 Track 2: Developing and Implementing the International CMC Data Standards to Improve the Post-Approval Change Process

3:45 PM — 5:00 PM

Session 9 Track 3: Taking Advantage of Generative AI to Optimize Regulatory & Medical Writing – Uses, Benefits and Risk Management

3:45 PM — 5:00 PM

Session 9 Track 4: The Transformational Impact of FHIR on Regulatory Affairs Now and in the Future

5:00 PM — 5:30 PM

RIM Working Group Open House and Team Meeting

Día 5 14 feb 2024

8:00 AM — 8:30 AM

Networking Breakfast in the Exhibit Hall

8:00 AM — 2:30 PM

Registration

8:30 AM — 9:45 AM

Session 10 Track 1: Leveraging Structured Content Authoring in Regulatory Submissions: Real-World Experience, Industry Insights and Tools

8:30 AM — 9:45 AM

Session 10 Track 2: Complying with EU CTR: Managing Business Change and Submissions in CTIS

8:30 AM — 9:45 AM

Session 10 Track 3: So, You Think Technology Solutions are Failing your Content Transformation? Did You Set Them up for Success?

8:30 AM — 9:45 AM

Session 10 Track 4: Electronic Product Information (ePI): A Digital Passport for Therapeutic Product Information

9:45 AM — 10:30 AM

Refreshment and Networking Break in the Exhibit Hall

9:55 AM — 10:25 AM

Hosted Session: Case Study Spotlight hosted by Genpact: AI was Meant to Have all the Answers. But is Regulatory Asking the Right Questions?

10:30 AM — 11:45 AM

Session 11 Track 1: Improving Regulatory Processes Through Data-Driven Metrics, Generative AI, and Effective Change Management

10:30 AM — 11:45 AM

Session 11 Track 2: Optimizing Submission Filings: Understanding the Challenges and Developing Strategies Accelerating Submission Delivery to Health Authorities

10:30 AM — 11:45 AM

Session 11 Track 3: Exploring Opportunities and Challenges of Cloud Technology for Industry and Regulators

10:30 AM — 11:45 AM

Session 11 Track 4: New Trends and Challenges in Combination Products, Companion Diagnostics, and Digital Health Technologies

11:45 AM — 1:00 PM

Networking Luncheon in the Exhibit Hall

1:00 PM — 2:15 PM

Session 12: International Regulatory Updates and Insights

2:15 PM — 2:30 PM

Closing Remarks

2:30 PM — 2:30 PM

Forum Adjourns

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Agenda

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