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17 June 2008

Martine Tratsaert.European QP Association Nominates Martine Tratsaert as new Advisory Board Member

The European QP Association nominated Martine Tratsaert, Senior Director & Qualified Person at Johnson & Johnson's Global Qualified Person Group, as a new member of its Advisory Board. Martine Tratsaert is one of the founders of the QP Association's IMP Working Group.

Martine graduated as a Pharmacist in 1992 at the Free University of Brussels (Belgium) and became an in Belgium registered Industrial Pharmacist in 1994.

She has brought her experience from the Public Hospital environment to Janssen Pharmaceutica in 1992, and she started her J&J career in the Chemical Quality Services department. She moved to the R&D-division in 1995 as Head of the Quality Assurance GMP department.

Since 1997, Martine took up the QP responsibilities for J&J Pharma R&D worldwide. For more than 10 years she combined the QP responsibility with being the Head of Chemical Pharmaceutical Development Quality Assurance (CPDQA).

Since there are J&J R&D companies spread all over the world, the decision was taken to install an independent Global QP Group that has oversight on all GMP activities performed.

One of the most important challenges she is involved in is the development of a QA system for clinical formulations, which on the one hand takes the safety of the patient into account, and, on the other hand the flexibility of the development environments.

The IMP Working Group:
The group was founded 2006, after the first QP Forum of the new European QP Association in Prague, Czech Republic. The aim was to address the needs of QPs working on Investigational Medicinal Products. Their first official meeting was held as a Pre-Conference Workshop as part of the 2007 QP Forum in Berlin, Germany. The objectives of the group were defined as follows:

  • Exchange experience
  • Exchange ideas/insights
  • Discuss interpretation of regulatory guidance
  • Discuss difficulties encountered in daily QP practice and how to solve them
  • Inform each other on country specific items (import, export, views of regulatory authorities)
  • Any other goals that the members may bring in
  • Try to influence HA by providing valuable input to new legislation
  • Installing core team dealing with new legislation would be an asset.

The group is currently facilitated by:
Martine Tratsaert:
Kati Mortier:
Annemiek Stijnen:

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