The EMEA has set a deadline for making eCTD’s mandatory for January 01, 2010. As this date approaches the two day sessions from MEGRA and AGES offers an important opportunity to look at some of the essential questions such as:
· Is there really need to use the eCTD format?
· If yes, when is the best time to change to an eCTD format?
· Open discussion points with MEGRA and AGES?
Wolfgang Witzel, President of LORENZ Life Sciences Group will present on the changes from the CTD to eCTD and he will explain how a Lifecycle can be handled in a dossier or where the changes can be made to receive an eCTD.
A practical example will also be given from a LORENZ expert on the second day using LORENZ docuBridge software. LORENZ docuBridge is a product which is used by large and small industries, as well as regulatory agencies (Austria, Canada, Germany, Poland, Slovenia) and service providers.
For further information on the programm click here.
About LORENZ Life Sciences Group
LORENZ Life Sciences Group (www.lorenz.cc) develops and markets software solutions for the Life Sciences market since 1989. LORENZ's solutions are geared specifically for submission assembly, review, publishing, validation and management. As the number one supplier of submission management systems in the world, as well as the largest supplier of eCTDs for U.S., European and Japanese submissions in the world, LORENZ is the technological market leader. With over 160 installations in 20 countries, LORENZ has built a reputable customer base. For more information, please click here to contact LORENZ. |
