EXTEDO eCTD Workshop in Greece

Event Start:

2020-03-11

Event Finish:

2020-03-12

Event Location:

Athens, Greece

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Update (10 March): The workshop will take place as scheduled.

We invite you to a 2-day eCTD workshop in Athens, Greece on 11/12 March 2020.

The first day will be a hands-on eCTDmanager Best Practices Workshop. Please bring you own laptop - no software installation required. Our trainer will show you the best ways to create a dossier, work with documents and hyperlinks, how to validate and export and much more.

On the second day, we will cover Advanced Topics, such as e-submissions in EU, US, China, procedure and submission types, CESP, Brexit, eCTD readiness, configuration, best practice and common errors, and other topics.

Agenda

Please click here to download the detailed workshop agenda.

Agenda Day 1: Best Practice Workshop – Hands-On

09:00 - 09:15 Welcome / agenda / training environment

  • Start eCTDmanager, user interface
  • Create dossier/submission: EU regional part (module 1 v 3.0.1)
  • EU M1 specifics: EU envelope, the eAF
  • Adding documents

10:30 - 10:45 Coffee Break
10:45 - 11:30 Session 2:

  • eCTD specific sections and node extensions, more ways to work with documents

11:30 - 12:30 Session 3:

  • Creating hyperlinks

12:30 - 13:30 Lunch
13:30 - 14:15 Session 4:

  • Validation/Finish/Export 0000
  • Validate business rules
  • Submission lifecycle
  • Edit envelope information in follow-up sequences

14:15 - 15:00 Session 5:

  • Document lifecycle
  • The cumulative submission

15:00 - 15:15 Coffee Break
15:15 - 16:30 Session 6:

  • From a National Procedure to an MRP
  • Non-eCTD dossiers

16:30 - 17:00 Final questions and closing


Agenda Day 2: Advanced Topics

09:00 - 09:15 Welcome / agenda
09:15 - 10:30 Session 1: Global regulatory update

  • Status of e-submissions in the regions (EU, US FDA, China …)

10:30 - 10:45 Coffee Break
10:45 - 12:30 Session 2: EU eCTD submissions regulatory information on:

  • Procedure types (NP, MRP, DCP, CP)
  • Submission types (e.g. MAA, variations)
  • CESP
  • What should you do in case of Brexit?

12:30 - 13:30 Lunch
13:30 - 15:00 Session 3: eCTD Readiness

  • From a single document to the eCTD submission
  • How to setup electronic submission in your company?
  • What are the tools you need?
  • Word templates

15:00 - 15:15 Coffee Break
15:15 - 16:15 Session 4:

  • Best practice of electronic submissions
  • Common errors in electronic submissions

16:15 - 16:45 Session 5: eCTDmanager add-ons

  • Configuration options
  • eCTDmanager goes cloud
  • Roadmap

16:45 -17:00 Final questions and closing

Venue

New Hotel (Yes Hotels Group)

16, Filellinon Str. & 1, Navarchou Nikodimou Str.
10557 Syntagma sq. Athens
Greece
T: +30 210 3273000
info@newhotel.gr 

Register here

The seats are limited, please register as soon as possible. We offer special discounts to companies who register with three or more colleagues, in order to learn more about this or for any other questions please contact Thomas Kessler: kessler@extedo.com.

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