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Day 1 2018年2月04日 (日)

10:00 AM — 5:00 PM

Regulatory Content and Submissions Primer: Tracking Content from Conception to Interment

Day 2 2018年2月05日 (月)

7:30 AM — 5:00 PM

Registration

8:30 AM — 12:00 PM

Course 1: Global Identification of Medicinal Products: Applied Principles and Practical Benefits from Compliance and Beyond

8:30 AM — 12:00 PM

Course 2: Essentials for Compiling/Publishing Compliant Electronic Submissions (eCTDs)

1:00 PM — 1:30 PM

Welcoming Remarks and Presentation of the Volunteer Award

1:30 PM — 2:00 PM

Session 1: Keynote Address: Introduction to Blockchain: Distributed Ledger Technology for Regulation and Supply Chain Security

2:00 PM — 2:30 PM

Refreshment Break in the Exhibit Hall

2:30 PM — 3:45 PM

Session 2: FDA Opening Plenary Panel: PDUFA VI Informatics

3:45 PM — 5:00 PM

Session 3: Other Regions Update

5:00 PM — 6:00 PM

Networking Reception in the Exhibit Hall

Day 3 2018年2月06日 (火)

7:30 AM — 8:30 AM

Networking Breakfast in the Exhibit Hall

7:30 AM — 4:00 PM

Registration

8:30 AM — 9:45 AM

Session 4: New FDA Draft Guidance on Part 11 in Clinical Investigations and Mobile Technologies in Clinical Investigations

9:45 AM — 10:30 AM

Session 5: FDA Ask the Regulators: Part I

10:30 AM — 11:00 AM

Refreshment Break in the Exhibit Hall

11:00 AM — 12:15 PM

Session 6 Track 1: HeRO Forum Benchmarking: Global Regulatory Sourcing Strategies for Evolving Regulatory and Industry Solution

11:00 AM — 12:15 PM

Session 6 Track 2: The Increasingly Critical Roles of RIM Systems and Their Expanding Number of Use Cases Beyond Regulatory Affairs

11:00 AM — 12:15 PM

Session 6 Track 3: Strategies for Ensuring Part 11/Annex 11 Compliance of eTMFs at Research Sites

11:00 AM — 12:15 PM

Session 6 Track 4: eCTD AdPromo Panel Discussion

12:15 PM — 1:45 PM

Networking Luncheon in the Exhibit Hall

1:45 PM — 3:00 PM

Session 7 Track 1: Paradigm Shift in Data Management and How to Enrich Business Intelligence to Benefit the Industry

1:45 PM — 3:00 PM

Session 7 Track 2: How to Compete in the Data-Driven Digital Transformation in the Pharmaceutical Industry?

1:45 PM — 3:00 PM

Session 7 Track 3: Understanding ICH E6 R2 and the Impact to Clinical Trial Documentation and the Trial Master File

1:45 PM — 3:00 PM

Session 7 Track 4: Keeping up with Trends in eCTD: Submitting in US Module 1 Specification

3:00 PM — 3:30 PM

Refreshment Break in the Exhibit Hall

3:30 PM — 4:45 PM

Session 8 Track 1: Processes - Don’t Make Them an Afterthought

3:30 PM — 4:45 PM

Session 8 Track 2: Transforming Regulatory Information Management Through Innovation

3:30 PM — 4:45 PM

Session 8 Track 3: Creating and Streamlining Regulatory Dossier Management

3:30 PM — 4:45 PM

Session 8 Track 4: Using Submission Management to Enable Streamlined Regulatory Planning

5:30 PM — 7:30 PM

Dinner on the Town

Day 4 2018年2月07日 (水)

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: Critical Success Factors for Implementation of Regulatory Information Management Capabilities

8:30 AM — 9:45 AM

Session 9 Track 2: Driving Innovation in Regulatory Technology within Life Sciences

8:30 AM — 9:45 AM

Session 9 Track 3: How to Utilize Systems and Technology as Document Enablers

8:30 AM — 9:45 AM

Session 9 Track 4: Regulatory Sourcing: Regulatory Sourcing - Who is Doing What and Some Real-World Industry Experiences

9:45 AM — 10:15 AM

Refreshment Break in the Exhibit Hall

10:15 AM — 11:30 AM

Session 10 Track 1: RIM 2020: Connecting to Other Functional Processes

10:15 AM — 11:30 AM

Session 10 Track 2: Artificial Intelligence (AI): The Next Frontier

10:15 AM — 11:30 AM

Session 10 Track 3: Panel Discussion: Managing Partnerships

10:15 AM — 11:30 AM

Session 10 Track 4: TransCelerate, FDA, and NIH: The Evolution of a Common Protocol Template

11:30 AM — 1:00 PM

Networking Luncheon

1:00 PM — 1:45 PM

Session 11: FDA: Ask the Regulators II

1:45 PM — 2:00 PM

Closing Remarks

Regulatory Submissions, Information, and Document Management Forum

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