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7 International Regulators

Including: Saudi FDA (Saudi Arabia) MHRA (UK), DHMA (Denmark), ANSM (France), Fimea (Finland), BfArM (Germany), SUKL (Slovakia)

EU telematics initiatives

Latest updates, developments and experiences on:

EU eSubmissions Roadmap, eCTD 4.0, CESP, EMA Gateway, eAF & eSignatures...

Globalisation of eCTD

Hear the latest developments, experiences and future progress on eCTD in:
- Saudi Arabia (from Saudi FDA)
- South Africa & Australia

Networking and experience sharing

3 new interactive sessions: The Experience Exchange, Top Table Panel Discussion & EU Telematics World Café


The 11th Annual Global eCTD Management Conference

Europe’s only electronic submissions conference for eCTD

Essential telematics updates, regulatory agency feedback and opportunities for sharing industry experiences on global eCTD challenges.

Save the date for 2015’s leading conference for regulatory affairs and operations teams working with eCTD. Join industry experts and regulatory authority representatives as they share their experience across key developments and challenges surrounding eCTD.

Interactive seminars

Make the most of your time away from the office and book a seminar place...

Pre-conference workshop day:


Preparing, submitting, validation and maintaining eCTD submissions


Pre-conference evening seminar:

Discovering the latest developments, practicalitiess and implications of eCTD v4.0/RPS

Evening Discussion:


Case Study Experience Exchange

Who will you meet?

Meet, network and make new contacts with the following professionals…

Heads, Senior Managers, Managers, Publishers, specialists from:

  • Regulatory operations
  • Submissions
  • Publishing
  • Regulatory affairs 
  • Regulatory Information
  • Dossier submissions & management
  • Document management

Delegates attend from large, medium and small pharma, biotech and generics companies

Why should you attend? Take a look at the conference highlights to find out.

Other Events That Will Interest You

Labelling & Packaging Summit

28 Oct 2014 - 30 Oct 2014
Maritim Hotel Berlin

CPD Accredited



Event Sponsors & Exhibitors