Agenda eRA 2019

subject to change

Day 2 - 23 May


09:00 eCTD 4.0 - New Major Version - Objectives, Benefits & Impact on Life Science Organizations - Sylvie Colin, SYLV’eDOCS

  • eCTD v4.0 concepts and benefits in plain language
  • High level considerations for transitioning from v3.2.2 to eCTD v4.0
  • Region-specific topics
  • Major advantages of eCTD 4.0

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 - Stefan Giura, independent consultant

  • The Change to R3 - Huge Hurdles for any organization, whether MAH or CRO
  • Best practices to be followed before the actual change
  • Personnel needs, training requirements and changes to procedures
  • An overview of actual R3 changes and how they affect the case workflow processes
  • Basic pitfalls and preparation needed in order to migrate the best quality data to the new system

 

 


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?

Moderated by Anjana Pindoria and Sandra Fadel, EXTEDO

Room B

11:00 What Are the Benefits of Coupling a Document Management Solution With eCTDmanager?

11:40 What Are the Benefits of Coupling a Document Management Solution With eCTDmanager?

Key topics: 

  • Documents and Archiving requirements for SMBs.
  • Internal and external collaboration.

Moderated by Guillaume Gerard, Agatha

Room C

11:00 Data Protection in Pharmacovigilance: Daily Challenges and Solution Possibilities

11:40 Data Screening in Eudravigilance – Burden or Benefit?  

Moderated by Dr. Reinhard Nibler, Nibler & Partner, Dr. Andrea Striebel and Benjamin Beier, EXTEDO


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