9th Annual Biomarkers Congress
Lifecycle Management of the eCTD
Hotel Bloom
Brussels
Belgium, xx
http://www.informa-ls.com/ectdlifecycle
Lifecycle Management of the eCTD
http://www.informa-ls.com/ectdlifecycle
Hotel Bloom
Brussels
Belgium

Schedule of Presentations:

Tuesday, February 24, 2009
08:30:00 Registration
09:00:00 Introduction from the Chair
09:10:00 eCTD lifecycle management in the centralised procedure Joerg Schnitzler
09:50:00 Clarifying the guidance on managing the eCTD and its lifecycles in the Mutual Recognition Procedure (MRP) and the Decentralised Procedure (DCP) Andrew Marr
10:30:00 Morning coffee
11:00:00 Maintaining lifecycles for a national product license in a number of member states
11:40:00 Spotlight session Ben Edwards
12:10:00 Use of the electronic application form (eAF) within and outside of the eCTD Hans van Bruggen
12:50:00 Lunch
14:00:00 Implementation of the new European specifications for module 1 Ron de Boer
14:40:00 Following Belgium through the implementation of the eCTD and lifecycle management Pieter Vankeerberghen
15:20:00 Afternoon refreshments
15:50:00 Update on MHRA experience with eCTD applications and guidance David Wheeler
16:30:00 eCTD and its lifecycle management in Norway Jostein Øksne
17:10:00 Discussion session on issues arising from the day, with a panel of the days industry and regulatory speakers
17:30:00 Closing remarks from the Chair and end of day 1
Wednesday, February 25, 2009
09:00:00 Opening remarks from the Chair
09:10:00 Lifecycle management strategies for parallel variations and tracking tables Anne Mieke Reijnders
09:50:00 Transition of legacy products to the eCTD and their lifecycle management Liesbeth Versteeg
10:30:00 Morning refreshments
11:00:00 Handling the eCTD and lifecycle management in affiliate offices Alastair Nixon
11:40:00 Successfully implementing an eCTD lifecycle management tool on a global submission Caroline Petersen
12:20:00 Spotlight session Ben Edwards
12:40:00 Future developments for the eCTD and lifecycle management Geoff Williams
12:50:00 Lunch
14:00:00 Developing an in-house tool for eCTD and product license management, and submission of an orphan drug eCTD Attilio Sarzi Sartori
15:20:00 Afternoon refreshments
15:50:00 Solve your eCTD lifecycle management challenges through eCTD Q&As Leigh Sandwell
16:30:00 Managing the lifecycle of an eCTD for a generic product Remco Munnik
17:10:00 Discussion session on issues arising from the day, with a panel of the days speakers
17:30:00 Closing remarks from the Chair and end of the conference
4th Annual Pharma R&D Asia Congress
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