FDA permission and Behördenmeetings (Pre IND Meeting, end to OF phase Ii-Meeting and Pre tender Meeting)
(openPR) - permission submissions with the FDA differ fundamentally from the European procedures. Already in early stages of the product development here co-operation begins with the American federal upper authority by fixed Meetings at the end of each development phase.
FORUM Institut for management, one of the prominent seminar offerers of Germany, offers a compact advanced training to interested coworkers of pharmaceutical enterprises for this topic. The intensive seminar takes place to 03.05.2007 in Cologne. Further information to the seminar and to the organizer finds you under: www.forum-institut.de/veranstaltung.aspSemNr=0705233
This intensive seminar focuses on the different procedures for the permission submission and informs in the detail about the associated Behördenmeetings. Of importance here in particular the possibility of an obtainment “of the Scientific Advice” is parallel from FDA and EMEA.
Contact:
Dr. Henriette wolf-small
Range chief Pharma
FORUM Institut for management GmbH, Heidelberg
Vangerowstrasse 18
69115 Heidelberg
Tel. 06221 500,680
Fax. 06221 500,618
h.wolf-klein@forum-institut.de
The FORUM Institut for management GmbH stands for 25 years for practice-oriented and founded knowledge transfer in enterprise questions on highest level. FORUM is 100% daughter of Springer Science + Business Media, one the offerer for science and technical literature, leading world-wide. The broadly varied offer covers conferences and conferences to current developments, in addition, seminars and training courses of several days. In the year 2005 more than 30,000 high-level personnel from almost all countries of Europe and from the United States participated on over 1.400 meetings of the institutes for forum.
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