Registration and Networking Welcome Coffee

Opening Address and Welcome
Martin Schmid, CEO, EXTEDO
The Global Regulatory Roadmap
[Speaker Name]
[Presentation Title]
[Speaker Name]

Networking Coffee Break

A 12 month recap of IDMP in Europe (DADI, SPOR, ePI, Target Operating Model)
[Speaker Name]
Agency Harmonization and Collaboration - Speeding up submission review & improving patients safety by connecting the world
[Speaker Name]
Advocating IDMP within your organization - A case study
[Speaker Name]

Networking Buffet Lunch

Break-Out Sessions

Break-Out Session 1

Global Overview of eCTD 4.0 - Current Status and Future Expectations
Highlights on issues between Industry and Agency by using eCTD submissions across regions
Authorities implementing eCTD - WHO, Singapore and Brasil, current status and next steps

Moderated by Dr. Anna Thaidigsmann, EXTEDO

Break-Out Session 2

[Presentation Title]
Navigating through the landscape of the new Clinical Trial Regulations and connections to the R3 standard
Interoperability between R2 & R3

Moderated by Stavros Kardahakis, EXTEDO

Break-Out Session 4

[Presentation Title]
[Presentation Title]
[Presentation Title]

Moderated by Anamarija Dolezal, EXTEDO

Break-Out Session 4

[Presentation Title]
[Presentation Title]
[Presentation Title]

Moderated by Michael Nikel, EXTEDO


Networking Coffee Break

Break-Out Session 1

Regional technical and regulatory differences of eCTD 4.0 - A comparative analysis
eCTD 4.0 - Industry vs. Agency - How to prepare? 

Moderated by Michael Faust, EXTEDO

Break-Out Session 2

Streamlining Safety Processes
The use of AI in Drug Safety

Moderated by Andrea Striebel, EXTEDO

Break-Out Session 3

[Presentation Title]
[Presentation Title]

Moderated by Terry Ivereigh, EXTEDO

Break-Out Session 4

[Presentation Title]
[Presentation Title]

Moderated by Keith Wallace, EXTEDO


End of Official Part Day 1
Evening Event and Dinner
meet in front of hotel for bus shuttle (included in all passes)