Manager of the Document Management and Publishing Team
Since February 2009
- implementation of new processes and tools (isipublisher, isi ectdxpress, isitoolbox) for the publishing of Marketing authorisation dossiers, and the implementation of the eCTD (electronic common technical document). creation of associated trainings;
- in charge of the Document Management of the submission documents and dossiers submitted to the authorities;
- implementation of the eCTD for canada, switzerland, gcc countries (bahrain, kuwait, oman, qatar, saudi arabia, and the united arab emirates);
- implementation of the authorities gateways (EMA gateway and gateway client developed internally, cesp);
- implementation of an archiving and viewing solution for eCTD submissions (rosetta pyramid);
- implementation of eCTD validators (extedo eurs validator and lorenz evalidator).
- Implementation of new processes and tools (ISIPublisher, ISI eCTDXPress, ISIToolBox) for the publishing of marketing authorisation dossiers, and the implementation of the eCTD (electronic common technical document). Creation of associated trainings;
- In charge of the document management of the submission documents and dossiers submitted to the authorities;
- Implementation of the eCTD for Canada, Switzerland, GCC countries (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates);
- Implementation of the authorities gateways (EMA Gateway and gateway client developed internally, CESP);
- Implementation of an archiving and viewing solution for eCTD submissions (Rosetta Pyramid);
- Implementation of eCTD validators (Extedo EURS Validator and Lorenz eValidator).
EU Publishing TeamAugust 2006 --- January 2009
Publisher and Project Manager for e-SubmissionsJuly 2001 --- July 2006
global regulatory systems and technology group – Project Manager
projects related to electronic publishing and the electronic dossier (within ucb and with the emea and efpia, Member of the efpia – eCTD topic group):
- implementation of the common technical document (ctd) format at ucb.
- implementation of coredossier (liquent) at ucb, for the publication of the submissions dossiers.
- XML: pim (product information management in europe) and FDA.gov/oc/datacouncil/spl.HTML">spl (electronic labeling in the united states) projects, electronic application form.
- eCTD/">eCTD (electronic common technical document).
- publishing of regulatory dossiers for european and international submissions, variations, answers to questions from the authorities, drug master file, Clinical Trial exemption and for periodic safety update reports.
- organization and management of electronic archiving for the submitted dossiers with documentum.
IT and Network AdminstratorJuly 1999 --- July 2001
LinkedIn Assessment :
Licence in Information and Document Management from Université libre de Bruxelles in 1998
LIcence in Communication (Journalism) from Université catholique de Louvain in 1990
Licence in History from Université Paris-Sorbonne in 1988
DEUG in History from Université Robert Schuman (Strasbourg III) in 1987
Baccalauréat in Philosophie, lettres, langues from Lycée Français de Belgique in 1984
Expert has 2 publications (Will be avalible with full profile)
Area / Region