Agenda eRA 2019

subject to change

Day 2 - 23 May


A5 Major Current and Future Regulatory Challenges

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 FDA Grouped Submissions – Agency Requirements and Best Practices for Submission Management - Ted Hanebach, ICON

  • The presentation will address the regulatory and process reasons and requirements for FDA submission grouping
  • Although, submission grouping offers time and resources savings, it also have significant limitations and can create unforeseen long term lifecycle risks.
  • Grouping submissions can also create a significant submission management challenges. During the presentation, we will discuss a practical approach to the management of such submissions.

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


A6-C6 Barcamps Part 2

Choose your favorite topics

Barcamp A6

11:00 Will eCTD and IDMP Come Together?

11:40 Will eCTD and IDMP Come Together?

Moderated by Anjana Pindoria and Sandra Fadel, EXTEDO

Barcamp B6

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

Barcamp C6

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


A7-D7 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.

A7 eCTDmanager Experts Meeting

13:30 Connecting the EXTEDO Products of Today, into the Future - Michael Nemec, EXTEDO

  • Vision
  • What´s New
    • Overview of the Global Regulatory Roadmap
    • A preview of the Product Roadmaps (eCTDmanager, EURSvalidator, eSUBmanager)

  • Customer Success Story
  • The future is here

    • A sneak peak into the progress of ongoing product releases

 

 

B7 PcVmanager Experts Meeting

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

  • Introduction
  • PcVmanager

    • Maintenance
    • News from Customer support

  • SafetyEasy

    • Introduction
    • SaaS: what is included
    • Regulatory and product roadmap(s)

  • How to use the validation documentation

C7 RIM Experts Meeting

13:30 RIM Experts Meeting Part 1 - Christian Kravogel, EXTEDO

  • Vision
  • What's New
  • Overview of the Global IDMP Roadmap
  • A preview of the Product Roadmaps (Corporate Product Dictionary, Planning and Tracking)
  • Interactive session to share feedback
  • Today's business processes and how to manage the pains
  • EXTEDO News

    • Services

D7 EURS & EURSnext Experts Meeting

13:30 Connecting the EXTEDO Products of Today, into the Future  - Andreas Wastl, EXTEDO

  • Vision
  • What´s New
    • Overview of the Global Regulatory Roadmap
    • A preview of the Product Roadmaps (EURS, EURSnext)

  • Share Your Process
  • EXTEDO News

    • Services


15:00 Networking Coffee Break


A7 eCTDmanager & eSUBmanager Experts Meeting

15:30 Experts Meeting Part 2 - Maren Müller, EXTEDO

  • EXTEDO News

    • e-Learning Platform
    • Services 

  • The future is near

    • Are you curious how your pains are transformed into solutions within your products? Learn how to speak about your pains and influence the product development. 

 

 

B7 PcVmanager Experts Meeting

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

  • Demo of SafetyEasy incl. Q&A
  • How to come from PcVmanager to SafetyEasy
  • Feedback and Closing Panel

C7 RIM Experts Meeting

15:30 RIM Experts Meeting Part 2 - Christian Kravogel, EXTEDO

  • The future is here

    • How eCTD and IDMP have come together today.

  • The future is near

    • Are you curious how your pains are transformed into solutions within your products? Learn how to speak about your pains and influence the product development.

D7 EURS Experts Meeting

15:30 The Future - Andreas Wastl and Sandra Fadel, EXTEDO

  • The future is here

    • Planning and reviewing with modern technology

  • The future is near

    • Are you curious how your pains are transformed into solutions within your products? Learn how to speak about your pains and influence the product development.


17:00 End of the Conference