Delegated QP clin trials / Responsible Person GDP
Since April 2015
Regulatory Affairs Manager / Responsible Person GDP
November 2007 --- September 2014
In charge of all submissions according to eCTD or Nees structures to the FAHMP and follow-up until national closure. Acting as the Responsible Person in charge of GDP system monitoring and improvement plan according to the New GDP Directive. Acting as the local coordinator of the pharmaceutical responsibility within the local affiliate (Be&Lux)
Qualified Person for Clinical Trials
January 2005 --- October 2007
in charge of batch certification of Investigational Medicinal Products in compliance with Directive 2001/20/EC, 2003/94/EC and GMP Annex 13. Approval of IMPD section of the CTA. Internal or external GMP audits and approval of CAPAs. Management of complaints, investigation or recall of IMPs.
Quality Assurance officer
April 2004 --- December 2004
QA officer for Global Clinical Supply Unit department. In charge of audit and maintenance of operational quality system (GMP) as well as follow-up of correctives actions. Also in charge of quality training of technical personnel.
Global Clinical Supply Unit Manager
January 1998 --- March 2004
Responsible for packaging, labeling, randomisation, distribution, returm & reconciliation of IMPs for clinical trials Ph I to IV. Also participating to the GMP contracts with CROs. Management of about 25 people.
Regulatory Affairs associate
January 1995 --- December 1997
In charge of filing Marketing Authorisation dossier, IND and CTX files related to the chemical and pharmaceutical aspects as well as their follow-up (updates and questions from Authorities).
in from Université libre de Bruxelles in 1993