Agenda eRA 2023

Day 1 - 05 July

subject to change


08:30 Registration and Networking Welcome Coffee


09:00 Opening Address and Welcome - Martin Schmid, Managing Director, EXTEDO

09:30 The Global Regulatory Roadmap -  [Speaker Name]

10:00 [Presentation Title] - [Speaker Name]

 


10:30 Networking Coffee Break


11:00 A 12 month recap of IDMP in Europe (DADI, SPOR, ePI, Target Operating Model) - [Speaker Name]

11:30 Agency Harmonization and Collaboration - Speeding up submission review & improving patients safety by connecting the world – [Speaker Name]

12:00 Advocating IDMP within your organization - A case study – [Speaker Name


12:30 Networking Buffet Lunch


Break-Out Sessions

eCTD

13:30 Global Overview of eCTD 4.0 - Current Status and Future Expectations

14:00 Highlights on issues between Industry and Agency by using eCTD submissions across regions 

14:30 Authorities implementing eCTD - WHO, Singapore and Brasil, current status and next steps

Moderated by [Name], EXTEDO

Safety

13:30 [Presentation Title]

14:00 Navigating through the landscape of the new Clinical Trial Regulations and connections to the R3 standard

14:30 Interoperability between R2 & R3

Moderated by [Name], EXTEDO

DMS (QM, Clinical)

13:30 [Presentation Title]

14:00 [Presentation Title]

14:30 [Presentation Title]

Moderated by [Name], [Company]

Additional Topics

13:30 [Presentation Title]

14:00 [Presentation Title]

14:30 [Presentation Title]

Moderated by [Name], [Company]


15:00 Networking Coffee Break


eCTD

15:30 Regional technical and regulatory differences of eCTD 4.0 - A comparative analysis

16:00 eCTD 4.0 - Industry vs. Agency - How to prepare? 

Moderated by [Name], [Company]

Safety

15:30 Streamlining Safety Processes 

16:00 The use of AI in Drug Safety

Moderated by [Name], [Company]

DMS (QM, Clinical)

15:30 [Presentation Title]

16:00 [Presentation Title]

Moderated by [Name], [Company]

Additional Topics

15:30 [Presentation Title]

16:00 [Presentation Title]

Moderated by [Name], [Company]


16:30 End of Official Part Day 1

[Time] Evening Event and Dinner - meet in front of hotel for bus shuttle (included in all passes)