EXTEDO EURS Experts Meeting / Training

EXTEDO is thrilled to be able to invite you to the 2018 EURS Experts Meeting and Training. This event is for delegates from Regulatory Authorities only.

The event includes a training to educate you and your team on advanced EURS functionalities. The User Group is also the perfect opportunity to learn more about forthcoming regulatory challenges as well as EXTEDO's product roadmap.

At the end of the first day EXTEDO invites you to join us for a conference dinner. This is your chance to meet and chat with key members of the EXTEDO team and network with other EURS users. You’ll pick up some great tips and insights and leave the conference with new ideas to help you optimize your business.

Agenda

(subject to change)

11 September 2018 - EURS Advanced Hands-on Training (optional)

Contribution towards expenses: €300

08:45-09:00 Registration

09:00-12:30 Getting more out of EURS (Ralf-Peter Berg, EXTEDO) 

  • Best practice in baselines and follow-sequences
    • Applicant's hyperlinks and document lifecycle
    • Identifying changes in sequences
    • Comparing document versions
  • Advantages of the Start Page
  • New quick links
  • Dossier groups
  • … and more

(11:00-11:15 Coffee Break)

12:30-13:00 Questions & Answers (Ralf-Peter Berg, EXTEDO)

11-12 September 2018 - EURS Experts Meeting

Contribution towards expenses: €200

11 September - Day 1

12:45-13:00 Registration

13:00-14:00 Lunch

14:00-14:15 Welcome (Maximilian Munte, EXTEDO)

  • Meeting Objectives
  • EXTEDO and NCA Business (Company update, new regions)

14:15-15:45 Update from EXTEDO (Andreas Wastl and Sandra Fadel, EXTEDO)

  • Product Updates & Highlights of EURSvalidator, EURS and EURSnext

15:45-16:15 Coffee Break and Networking

16:15-17:00 Update from the NCAs “Share your Processes” 

  • Happy Flow from Application to Approval
  • Present what you are proud of (config, automation, processes)
  • Questions & Answers

17.00-17:30 Feedback from industry to the NCAs (Maren Müller, EXTEDO)

  • Presentation of topics we learned from our industry clients

18:00-18:45 Meet at Hotel Platzl bar for a drink

19:00 Dinner at Restaurant "Ratskeller" (Marienplatz, ground floor of town hall)

12 September - Day 2

09:00-10:15 The Future of Reviewing (Andreas Wastl and Michael Gessert, EXTEDO)

  • EURSnext - the next EURS!
    • Functionality of EURSnext
    • Co-Existence of EURS and EURSnext
    • Collaboration between EURS & EURSnext
    • Distributed reviewing with EURSnext
    • EURS in the cloud?
    • Migration scenario

10:15-10:45 How eCTD & IDMP will work together (Anjana Pindoria, EXTEDO)

10:45-11:15 Coffee Break and Networking

11:15-12:45 Round Tables to Discuss, Exchange, Prioritize        

  • Discussion and Exchange
    • Stumbling blocks in EURS – Understanding your processes and goals
    • Small is beautiful - What do your users need from EURSnext?
    • The regulatory crystal ball - Upcoming challenges and how to handle them
  • Presentation of results with all attendees

12:45-13:45 Lunch and Networking

13:45-15:00 Increase Efficiency (Christine Hirt, Michael Gessert and Ralf-Peter Berg, EXTEDO)

  • EXTEDO product services for NCAs                                                     
  • EURS automation components
  • Get things done quicker (Best Practice in Administration, Import, Review)

15:00-15:30 Final Questions, Feedback, Wrap-up and Closing of Event

15:30-16:00 Coffee and Networking

 

Venue

Platzl Hotel, Sparkassenstraße 10, 80331 Munich, Germany. It is located 300m from "Marienplatz". From the airport, you can use all suburban trains (S1/S8).

Accommodation is not included and needs to be booked separately.

Registration

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