- email:registrations@informa-ls.com
- phone:+44(0)20 7017 7481
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Lifecycle Management of the eCTD
28 - 29 February 2012
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SAVE THE DATE!
Europe’s Premier electronic submissions conference for Lifecycle Management of the eCTD
Featuring:
- Re-focused agenda for 2012: Including increased SME topics
- Expanded eCTD globalisation session
- New presentations detailing Module 1 and 2 challenges
- Outsourcing and SME approaches
- Exclusive evening seminar on the eCTD Validation criteria
Informa Life Sciences’ 2012 Lifecycle Management of the eCTD conference is a ‘must attend’ event for those working in electronic submissions wanting to keep updated on the latest regulatory developments, eCTD initiatives, industry best practice and global perspectives on eCTD progress.
Sessions will include:
- Exploring the eCTD future
- Globalisation of the eCTD
- Approaching eCTD as Small and Medium Enterprise (SME): Lifecycle Management, best practices and outsourcing
- Best practice Lifecycle Management for eCTD Modules
- Successfully managing MRP and DCP submissions
- Filing Variations and eCTD Lifecycle Management
- eCTD Regulatory insights and feedback
- Current Regulatory agency requirements, experience and expectations for eCTD submissions
New regulators for 2012!
Saudi Arabia
Hassaan Alwohaibi, Manager of Regulatory Affairs – Licensing Department, Saudi Food and Drug Authority, Saudi Arabia
Slovenia
Matevž Oset, eCTD Documentalist, The Public Agency for Drugs and Medical Devices of Slovenia (JAZMP), Slovenia
You will meet the following electronic submission practitioners...
Click here for the full speaker faculty
You will meet the following electronic submission practitioners...
Juha-Pekka Nenonen
Director, Information Resources Development,
Finnish Medicines Agency
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Christian Dinter
Global Submissions Manager, Global Submission Management and Archive
Bayer Pharma AG
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Hans van Bruggen
Senior Regulatory Affairs Consultant and Director
eCTD Consultancy
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Pia Holm
e-Submission Manager
Ferring Pharmaceuticals
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Sponsor
Exhibitors
Media Partners
MODULE 3...
PRE-CONFERENCE WORKSHOP
Maximising Module 3 lifecycle management for efficiency and compliance
Hans van Bruggen, Senior Regulatory Affairs consultant and Director at eCTD Consultancy
Don't miss these interactive sessions:
Pre-Conference Workshop W: Monday 27 February 2012
Maximising Module 3 lifecycle management for efficiency and compliance
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Evening Seminar: Tuesday 28 February
Successfully meeting the new validation criteria across the EU
Other Events That Will Interest You
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News/Updates
Speaker Announcement:
Pieter Vankeerberghen, Head of ITC Development and Projects for Belgium's Federal Agency of Health and Medicinal Products confirmed as speaker on Tuesday's evening seminar.
Dates and Venues
28 Feb 2012 - 29 Feb 2012
Pestana Chelsea Bridge Hotel London
