Webinar: Updates of ASMF Submission Rules - How to easily create eCTD ASMFs in EXTEDO´s DOCmanager

EXTEDO invites you to its Complimentary Webinar "Updates of ASMF Submission Rules- how to easily create eCTD ASMFs in EXTEDO´s DOCmanager".

The use of the eCTD format for centralised procedure human ASMF submissions will become mandatory from 01 July 2016.
Furthermore, a number of submission rules have been changed for eCTD submissions in the centralised procedure. Also, the new EU Module 1 eCTD specification will require some fundamental changes.
The relevance for ASMF submissions will be introduced by experts from PhACT and EXTEDO, who will show you how to get ready for the new requirements.

Agenda

1.  Dr. Barbara Jentges, Senior Drug Regulatory Affairs Expert and Managing Director of PhACT GmbH, will speak about:

  • Updates of ASMF submission rules
    • eASMFs used in the centralised procedure (CP)
      • eCTD format mandatory from 01 July 2016
      • XML delivery file required for electronic submissions
    • New EU M1 eCTD specification (v3.0 and v3.0.1) - relevance for eASMF submissions
  • Quick Procedural Reminder
    • EMEA/ASMF number or EU/ASMF number
    • EU ASMF assessment worksharing

2. In the second part of this webinar, Maren Müller, Senior Business Consultant at EXTEDO, will show you the ASMF creation in eCTD format, using EXTEDO´s DOCmanager

3. Q&A Session

Event Details

Date: Thursday, 09 June 2016

Time:

  • 10:00 am EDT (New York, Philadelphia)
  • 03:00 pm BST (London, Lisbon)
  • 16:00 h CEST (Madrid, Berlin)

Duration: 1 Hour

Registration (free of charge): attendee.gotowebinar.com/register/1103262436921905923

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