Including: Saudi FDA (Saudi Arabia) MHRA (UK), DHMA (Denmark), ANSM (France), Fimea (Finland), BfArM (Germany), SUKL (Slovakia)
Latest updates, developments and experiences on:
EU eSubmissions Roadmap, eCTD 4.0, CESP, EMA Gateway, eAF & eSignatures...
Hear the latest developments, experiences and future progress on eCTD in:
- Saudi Arabia (from Saudi FDA)
- South Africa & Australia
3 new interactive sessions: The Experience Exchange, Top Table Panel Discussion & EU Telematics World Café
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.
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
Meet, network and make new contacts with the following professionals…
Heads, Senior Managers, Managers, Publishers, specialists from:
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.