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).
EU Publishing Team
August 2006 --- January 2009
- Setting up of the publishing unit for the marketing authorisation dossiers in Europe, Middle East, Africa, Turkey and Russia;
- Management of the publishing and of the publishing plannings;
- Document management of the published dossiers;
- BMS delegate within the eCTD EFPIA group.
Publisher and Project Manager for e-Submissions
July 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 SPL (electronic labeling in the United States) projects, electronic application form.
- eCTD (electronic Common Technical Document).
Regulatory Associate /Document Management and Publishing
- 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 Adminstrator
July 1999 --- July 2001
- Implementation and administration of a local area network (intranet) and of a library management system (Alexandrie – G.B. Concept).
- Daily maintenance of computers and network (repair and upgrading).
- Staff and students training (search on the Internet, use of the computers).
January 1998 --- June 1999
- Setting up of an electronic document management service at the financial co-ordination center of the Bongrain Group in Brussels.
- On-line database and internet research, preparation of information dossiers.
January 1994 --- December 1997
• Translation, revision and editing of books for a publishing house (English, Dutch, Spanish and Italian into French)
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)