Agenda eRA 2019

draft version - subject to change

Day 2 - 23 May


09:00 The eCTD 4.0 Project at a Regulatory Authority

09:30 Publishing Services as a Crucial Support for the Regulatory Team - Sophia Vraka, Bavarian Nordic

 

  • Managing a high amount of hyperlink creation
  • Ensure the best quality by reviewing hyperlinks
  • Check and adapt word documents to stick to eCTD requirements
  • Get BLA pdfs eCTD ready

10:00 Preparing for R3 – What should be done


10:30 Networking Coffee Break


Barcamps Part 2

Choose your favorite topics

Room A

11:00 Will eCTD and IDMP come together?

11:40 Will eCTD and IDMP come together?

Room B

14:10 Document Management and Archiving Requirements for Small and Medium Sized Companies

14:50 Document Management and Archiving Requirements for Small and Medium Sized Companies

Room C

11:00 Supporting the Colaboration between CRO and the Sponsor

11:40 Supporting the Colaboration between CRO and the Sponsor


12:20 Closing Remarks


12:30 Networking Buffet Lunch


Experts Meetings

The experts meetings (user group meetings) are limited to customers of the respective product. The EURS Experts Meeting is open for Regulatory Authorities only.

Non-customers are invited to visit our demo stations during that time.

eCTDmanager Experts Meeting

13:30 Modules & Services Roadmap - Maren Müller, EXTEDO

  • Introduction
  • Regulatory Roadmap
  • Submission Product Roadmaps eCTDmanager and EURSvalidator
  • eCTDmanager – Services

    • Word Templates
    • Publishing Services
    • Database Health Check
    • eCTDmanager Hosting

  • News from Customer Care
  • Client Presentation

PcVmanager Experts Meeting

13:30 Experts Meeting Part 1 - Dr. Andrea Striebel and Benjamin Beier, EXTEDO

  • Introduction
  • Regulatory roadmap
  • PcVmanager – Current status and future perspective

MPDmanager & RImanager Experts Meeting

13:30 Experts Meeting Part 1 - Anjana Pindoria, EXTEDO

  • Interactive session to share feedback/opinions from the eRA sessions.
  • How the EU Business Drivers for IDMP could impact the industry.
  • Today's business efficiencies and how to manage the future demands.

EURS Experts Meeting

13:30 Experts Meeting Part 1 - Andreas Wastl, EXTEDO

  • Product Updates & Highlights of EURS, EURSvalidator and EURSnext
  • Experiences from NCA / Share your Process
  • Roundtables: importer/uploader, registrator, reviewer

15:00 Networking Coffee Break


eCTDmanager & eSUBmanager Experts Meeting

15:30 New Features, Q&A - Maren Müller, EXTEDO

  • EXTEDO goes SaaS
  • Submission Product Roadmap eSUBmanager
  • eCTDmanager and eSUBmanager Synergies
  • eSUBmanager trial version - demo
  • Q&A
  • Closing Remarks

PcVmanager Experts Meeting

15:30 Experts Meeting Part 2 - Dr. Andrea Striebel and Benjamin Beier, EXTEDO

  • Share your Experience - We will discuss questions and issues brought forward by you in the run-up to this meeting
  • News from Customer Care
  • Feedback and Closing Panel 

MPDmanager & RImanager Experts Meeting

15:30 Experts Meeting Part 2 - Alexander Beck, EXTEDO

  • How to reduce the maintenance effort for a product dictionary using artificial intelligence.
  • The pains of RMS & OMS and how to keep internal systems in sync.
  • EXTEDO solutions to manage the shift towards a big data world
    • RImanager and MPDmanager
    • Use cases for Managing IDMP
  • EXTEDO Offering
    • Product Roadmap
    • Service offerings

     

EURS Experts Meeting

15:30 Experts Meeting Part 2 - Andreas Wastl, EXTEDO

  • Collaboration between EURS and EURSnext
  • Campfire Discussion / Coffee Table Discussion
  • Fusion of eCTD & IDMP
  • Updates from EXTEDO Teams

    • Services for NCAs
    • News from Customer Care


17:00 End of the Conference