Complimentary Webinar: Journey to CTD, NeeS & eCTD Submissions

EXTEDO invites you to its Complimentary Webinar "Journey to CTD, NeeS & eCTD Submissions".

During the webinar, Asmaa Khalil (MENA Regulatory Affairs Manager at Boston Biopharma) will give you an introduction about the CTD, NeeS and eCTD standards and explain how an electronic submission is created.

After the theoretical part, a live demo will be presented by Maren Müller (Product Manager, EXTEDO). You will see how an eCTD dossier is created, validated and reviewed using EXTEDO's submission management solutions.

Following the presentation the speakers will answer your questions in the Q&A session.

Agenda

1. EXTEDO Corporate Intro
2. Introduction into the CTD, NeeS and eCTD standards

  • Definitions and differences between the standards
  • CTD triangle
  • Regulatory process
  • Status of global implementation of CTD, Nees and eCTD at health authorities
  • Cases of CTD modules
  • Templates of common global sections requested in M1
  • Content overview M2, M3, M4 M5
  • eCTD criteria and advantages
  • Criteria and creation of NeeS and eCTD

3. Software Demo

  • Creation of an eCTD dossier
  • Validation
  • Reviewing process

4. Questions and Answers

Speakers

  • Asmaa Khalil, MENA Regulatory Affairs Manager, Boston Biopharma

  • Maren Müller, Product Manager, EXTEDO

Event Details and Registration

Thursday, 03 September 2020

09:00 am BST (London, Lisbon)
10:00 am CEST (Berlin, Cairo)
11:00 am MSK (Moscow)
12:00 am GST (Dubai)
04:00 pm CST (Bejing, Taipei)

Duration: 60 Minutes

Participation is free of charge.