17 June 2008
 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: mtratsae@prdbe.jnj.com
Kati Mortier: kmortier@prdbe.jnj.com
Annemiek Stijnen:
Annemiek.Stijnen@kinesis-pharma.com
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