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Expert speaker faculty
Mickel Hedemand Internal Adviser, Licensing Division Danish Health and Medicines Authority (DHMA)
Klaus Menges Director Federal Institute of Drugs and Medical Devices (BfArM)
Matt Hillier Submission Centre Team Lead, Information Processing Unit MHRA
Miguel Bley European Affairs Coordinator, ANSM
Regulatory agencies
Miguel Bley European Affairs Coordinator, ANSM
Dr Klaus Menges Head of the Unit Scientific Quality Assurance and Process Organisation BfArM
Mickel Hedemand Internal Adviser, Medicines, Regulation & Marketing Authorisations Danish Health and Medicines Authority (DHMA)
Matt Hillier Submission Centre Team Lead, Information Processing Unit MHRA
eCTD Seminars

Evening Seminar

Key event features:

Key Features

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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)
- ASEAN
- South Africa & Australia

Networking and experience sharing

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

 

The 10th 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 2014’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 evening seminar: Monday 24 February 2014

Communicating eCTD requirements to ensure submission ready documents

 

Led by: Lone Bo Sisseck, Regulatory Associate, Novo Nordisk AS, Denmark
Anne Westh, Regulatory Associate, Novo Nordisk A/S, Denmark
Phoebe Naveed, eSubmission Manager, Global Regulatory Affairs, Linde Healthcare AB, Sweden

 

 

Evening seminar: Tuesday 25 February 2014

eCTD 4.0 Progress update and implementation considerations: What can industry expect and when?

 

Led by: Klaus Menges, Director, Federal Institute of Drugs and Medical Devices (BfArM), Germany
Andreas Franken, Head of Clinical Research, Manager eSubmission, German Medicines Manufacturers Association (BAH), Germany

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.

Event Countdown

 

Other Events That Will Interest You

Pharmaceutical Licensing and Collaboration Agreements: Legal...

06 Nov 2014 - 06 Nov 2014
Steigenberger Frankfurter Hof Hotel, Frankfurt, Germany


CPD Accredited

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Event Sponsors & Exhibitors

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Media Partners

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