FORUM: The eCTD - Presentations & computer demonstration on dossier submission - 15.6.2009

Topics

• NeeS or eCTD - the principles & the acceptance in Europe
• eCTD compilation for European submissions - the authorities' national peculiarities
• eCTD for national submissions in Bulgaria
• Hands-on exercise - first compilation of an eCTD and follow-up submissions

Speakers

Holger Spalt, EXTEDO GmbH

Dr. Maren von Fritschen, PharmaLex GmbH

Assoc. Prof. Tatyana Benisheva-Dimitrova, Faculty of Public Health, Medical University Sofia, Bulgaria

Rila Hotel
Kaloyan Street, 6
1000 Sofia, Bulgaria

www.forum-institut.com