EXTEDO eCTDmanager European User Group Meeting / Training

EXTEDO is thrilled to be able to invite you to the 2018 European eCTDmanager User Group and Training Workshops.

The event includes a training to educate you and your team on advanced eCTDmanager functionalities. The User Group is also the perfect opportunity to learn more about forthcoming regulatory changes 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 eCTDmanager 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)

05 June 2018 - eCTDmanager Advanced Training (optional)

We will offer an optional 1-day training course (09:00 - 17:00h, €500) with the topics as follows (download full agenda):

  • Electronic Submission Management & the CTD Background
  • The US DMF - Create a new API Dossier with US M1
  • Create Hyperlinks
  • Export of eCTD of Submissions
  • Additional Features in higher Submissions
  • DOCmanager

19:00 Pre-conference Dinner (included for all training and meeting participants)

06 June 2018 - eCTDmanager User Group Meeting

Contribution towards expenses: €200

09:00 Welcome & Intro – Martin Schmid and Maximilian Munte, EXTEDO

09:15 EXTEDO Vision – Anjana Pindoria, EXTEDO

  • Telematics Strategy
  • Global Regulatory Roadmap - US, EU, Asia and RoW

09:30 Regulatory Information Management: Challenges and Opportunities? - David Kolosic, ASPHALION and Anjana Pindoria, EXTEDO

10:00 Global Regulatory Roadmaps - Christine Hirt, EXTEDO

  • eCTD, eCTD 4.0
  • Drug Safety
  • IDMP

10:30 Introduction to eCTD 4.0 – William Gardner-Mims, EXTEDO

  • Timelines EU, US, CA, JP
  • Drives and benefits
  • Technical background

11:00 Coffee break

11:30 Product Roadmaps – Maren Müller, EXTEDO

  • eCTDmanager
  • EURSvalidator
  • eSUBmanager

12:00 eCTDmanager 5.0 Demo – Maren Müller, EXTEDO 

  • Integration with Veeva Archive
  • EU M1 V3.0.3
  • CA eCTD Masterfile (applicants-/closed part concept)

12:45 Lunch break

  • RImanager (planning & tracking) demo station open

14:00 New EXTEDO Release Process – Hans-Ulrich Seufert, EXTEDO

14:30 Best Practices for Installing and Upgrading – Sven Pallarz, EXTEDO

14:45 eCTDmanager Upgrade Services - Michael Faust, EXTEDO

15:00 How EXTEDO Supports Your Business - Christine Hirt, EXTEDO; Ciprian Muntean and Doru Potop, B.Braun

  • B.Braun Customer Success Story
  • Regulatory Consulting
  • Managed Services

15:30 Coffee Break

  • RImanager (planning & tracking) demo station open

16:00 Customer Support Update – Keith Wallace and Sven Pallarz, EXTEDO 

16:30 Word Templates - William Gardner-Mims, EXTEDO

  • What are Word Templates?
  • How do they make your life easier?

17:00 Wrap up and Q&A

Venue

Excelsior Hotel, Schützenstr. 11, 80335 Munich, Germany. It is located 100m from "Hauptbahnhof" (main station). From the airport, you can use all suburban trains (S1/S8) or the Lufthansa Express Bus.

Accommodation is not included and needs to be booked separately. We have reserved a block of rooms in the "Anna Hotel", very close to the venue. Rooms can be booked for € 180 per night with the keyword "EXTEDO" at tel. +49 89 55137 8195 or res.anna@geisel-privathotels.de before 14 May. You might get rooms in the venue hotel or better offers through booking.com, hotels.com or other booking sites.

Registration

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