EXTEDO eCTDmanager North American User Group Meeting / Training

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

The event includes classes to educate you and your team on eCTD publishing basics, as well as more advanced eCTDmanager product training. 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)

21 March 2018 - Training Courses (optional)

We will offer two optional 1-day training courses (09:00 AM - 05:00 PM):

  • Advanced eCTDmanager Training ($500 - download detailed agenda here)
    • Advanced eCTDmanager Functionality like FDA 3.3, Incremental Export, Submission Staging, Cross Application References and Hyperlinking, SPLs, ePaper
    • Architecture, Configuration and Maintenance of eCTDmanager
    • eCTD 4.0: Regulatory Timelines, Terminology and Concepts
  • eCTD Publishing Training ($300 - download detailed agenda here)
    • eCTD Basics
    • Document Publishing
    • Word Templates
    • Submission Publishing

 

06:30 PM Pre-conference Dinner (included for all training and meeting participants)

We have reserved seats in a Mexican restaurant close (0.3mi) to the Marriott Hotel: El Vez, 121 South 13th Street, Philadelphia, PA 19107.

You can either meet us in the hotel lobby at 06:15pm or come to the restaurant at 06:30pm directly.

22 March 2018 - eCTDmanager User Group Meeting

Contribution towards expenses: $200

 

09:00 AM Welcome & Intro – Martin Schmid and Kyle Stretch, EXTEDO

09:15 AM Regulatory Roadmaps – Jason Grube, EXTEDO

  • eCTD & eCTD 4.0 in US, EU, Asia and RoW

10:00 AM Introduction to eCTD 4.0 – William Gardner-Mims, EXTEDO

10:30 AM Coffee break

11:00 PM Product Roadmaps (eCTDmanager, EURSvalidator, eSUBmanager) – Maren Müller, EXTEDO

11:45 AM Word Templates - William Gardner-Mims, EXTEDO

12:15 PM Lunch break

  • RImanager (planning & tracking) demo station open

01:30 PM eCTDmanager 5.0 and Future Outlook – Maren Müller, EXTEDO 

  • Integration with Veeva Archive
  • Fileshare and DMS support
  • Grouped Submissions
  • eCTD 4.0

02:30 PM EXTEDO Release Process – Maren Müller, EXTEDO

03:00 PM Coffee Break

  • RImanager (planning & tracking) demo station open

03:30 PM Best Practices for Installing and Upgrading – Sandesh Piya, EXTEDO

04:15 PM Technical Support Process and Customer Portal – Michelle Major, EXTEDO 

05:00 PM Wrap up and Q&A

Venue

Philadelphia Marriott Downtown, 1201 Market St, Philadelphia, PA 19107, USA

Accommodation is not included and needs to be booked separately (no group rate available).

Registration

conference - Online Event Management with the ticketing solution from XING Events

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