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Building the eCTD: Practical Approaches to Compiling Electronic Submissions (description)

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Category:Healthcare/Pharmaceutical
Address:Khalid Bin Walid Street Dubai, , United Arab Emirates
Phone:+41 61 225 51 51
Event dates:12/12/2016 - 12/13/2016 (This event has already taken place)
Event web site:http://go.evvnt.com/71318-0
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Speakers/Presenters:

Topics to be Covered:

  • Science, Health and Medicine / Pharmaceuticals / Regulatory Affairs
Contact:daniel.hartman@diaglobal.org
Organizer phone:+41 61 225 51 51
Offering type:Conference
Specialty:Data not provided
Event frequency:Never
First Meeting:
Total events:
Est. attendance:
Target audience:Any
Other target audiences:
Host Sponsor:DIA
Est. # of exhibitors:
Currency:Euro
Language:English
CE Credits:
Organizer URL

Description:

This course will offer insight into the compilation of the eCTDs, share experience and best practice gained during eCTD submissions and explain the eCTD review und lifecycle process. Especially eCTD submissions in the GCC region will be addressed in detail.

What you will learn

- Overview of eCTD readiness at the agencies
- Impact of the eCTD on regulatory processes and procedures
- Practical experience of submitting an eCTD in the EU and GCC
- eCTD compilation and life cycle management
Document granularity and readiness
Regulatory strategy facing technical issues
Specifications and standards versus regions and procedures

Schedule:

8:00 am to 5:40 pm

Registration Fee Details:

Standard: EUR 1605

Other items that tuition includes:

Travel and hotel arrangements:

 
 
Contact Person:Daniel Hartman
Contact Emaildaniel.hartman@diaglobal.org
Organizer Address 1Küchengasse 16
Organizer CityBasel
Organizer State/Province: (Outside US)Basel
Organizer Zip or Postal Code4051
Organizer CountrySwitzerland
Organizer Phone+41 61 225 51 51
Structural makeupData not provided
Host Sponsor; Other SponsorsDIA
Event Site/VenueFour Points by Sheraton Bur Dubai
Event sold out?No
Multiple locations or dates?No
Statistics available for most recent event held in:NA
Average number in event attendance of:
Range:
Number in attendance of:
Range:
Target BoundariesInternational
Is Registration contact information the same as Organizer Contact above?Yes
Web Page
Can one register for your CE on your web site?NA
Can registration be made by snail (regular) mail?Yes
Online housing reservations: 
 
Do you have additional written or AV materials for sale?No
If so, are they available for non-attendees as well as those attending?NA
Is full tuition necessary to ensure registration?No
Will there be shuttle service available?NA

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