- email:registrations@informa-ls.com
- phone:+44(0)20 7017 7481
Lifecycle Management of the eCTD
Europe’s Premier Industry Event for keeping abreast of Best Practice eCTD Lifecycle Management
Informa Life Sciences’ biannual Lifecycle Management of the eCTD conference is reputed on providing you with the current industry and regulatory perspective on best practice lifecycle management of the eCTD.
This is an opportunity for companies at all stages of eCTD implementation to share experiences and learn from peers to ensure that the eCTD does not delay your time to market.
October 2010 Conference Highlights
- Did you know that your eCTD submission can be rejected if it does not meet archiving requirements? read more
- Exchange eCTD lifecycle management experiences with peers and work through lifecycle management problems read more
- What implication has the new Variations Regulation had on your submission process? read more
PLUS DON'T MISS...
NEW FOR 2010:
Pre-conference workshop: Introduction to the eCTD and Lifecycle Management
An essential pre-conference session for those new to the area of eCTD
Evening Seminar: Re-use of electronic dossiers for product registrations: Realising the global dossier?
Join in this topical discussion on the possibilities of a 'truly global' dossier and take home practical advice on monitoring and managing eCTD lifecycles in a global market
BACK BY POPULAR DEMAND:
Best Practice Lifecycle Management of Module 3
This practical workshop is designed to provide you with solutions and take-home advice on issues arising from the lifecycle management of module 3 and CMC variations
Best Practice Lifecycle Management of Module 3
This practical workshop is designed to provide you with solutions and take-home advice on issues arising from the lifecycle management of module 3 and CMC variations
full workshop details
Who You Will Meet...
Who You Will Meet...
Ricco van den Hoorn
Information Manager
Medicines Evaluation Board
|
Cecile Levy
Record Manager
AFSSAPS
|
Hans van Bruggen
Senior Regulatory Affairs Consultant
eCTD Consultancy
|
Farhad Farsi
R&D Director
Abdi Ibrahim
|
Christian Dinter
Global Submissions Manager
Bayer Schering Pharma
|
Murat Hamzakadi
Associate Regulatory Operations Director
Astellas
|
Spotlight Session Sponsor
Event Sponsor
Media Partners
PROGRAMME UPDATES
Topic Announcement
Managing Lifecycle issues caused by changes in guidance and validation rules
James Hendry, Regulatory Process Consultant - EU, ISI Europe, UK
NEW FOR 2010: Pre-conference Workshop
Introduction to the eCTD and Lifecycle Management
An essential pre-conference session for those new to the area of eCTD
MUST ATTEND...Evening Seminar
Re-use of electronic dossiers for product registrations: Realising the global dossier?
Join in this topical discussion on the possibilities of a 'truly global' dossier and take home practical advice on monitoring and managing eCTD lifecycles in a global market
BACK BY POPULAR DEMAND: Post-conference workshop
Best Practice Lifecycle Management of Module 3
This practical workshop is designed to provide you with solutions and take-home advice on issues arising from the lifecycle management of module 3 and CMC variations
Expert Panel Discussion
Use this opportunity to have your burning questions answered by the regulators and industry experts.
Email your questions to: meera.byatt@informa.com
Dates and Venues
12 Oct 2010 - 13 Oct 2010
NH Amsterdam Centre
Reviews
"Informative, and good exchanges of experiences"
"Very useful to hear the latest experiences from industry as well as regulators"
