Pharmaceutical Development: EMEA QWP plans for 2009

The European Medicines Agency (EMEA) CHMP/CVMP Quality Working Party (QWP) has published its joint Work Programme for 2009. This document gives an overview about current and future activities of the joint QWP Work Programme.

One focus of the activities will be on new technologies and approaches to quality, especially in the field of Pharmaceutical Development. Both Working Parties are planning to discuss the impact of new approaches like for example described in the ICH Guidelines Q8 (Pharmaceutical Development), Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality Systems). In this context the QWP also wants to further contribute developing and implementing the respective ICH Guidelines. It is also planned to release the draft Guideline on Pharmaceutical Development of Medicines for Paediatric Use for public consultation.

In co-operation with the GMP/GDP Inspectors Working Party, the joint QWP will discuss the further development of the EMEA PAT Team and will continue its collaboration with the American Food and Drug Administration(FDA).

The joint CHMP/CVMP Quality Working Party Work Programme can be found here.

Compiled by
Wolfgang Schmitt
On the behalf of the European Compliance Academy (ECA)

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