Q2 2014 Centralised Procedure

This quarter the long-awaited EMA comments on the marketing authorization application for  the centralized procedure which is handled by us came in. Not that bad after all with only  64 issues to be solved while the mean number of comments for  such procedures amounts to 200. Still quite a lot of work to be done in the months ahead until December which is the deadline for the submission of our responses.Quite an uncommon project this quarter is the evaluation of a hospital pharmacy of a major Dutch hospital. We usually focus on quality aspects of organizations but this time is different and we need to look at other issues as well. Such issues concern the organizational structure of the pharmacy as well as the question whether its operations are efficient and  comply with the current state-of-the-art in hospital pharmacy. And will these processes stand the test of time in the upcoming years?  While  all major hospital pharmacies also provide pharmaceutical care to nursing homes their commercial capabilities become increasingly important as competitors are eager to take over their work. All in all this is quite an interesting task which appeals to almost any competence within our agency.
But luckily we also did take in some more standard projects which  do not require us to operate on the edge of our capabilities. Such were requests from a Top-10 pharmaceutical company in the Netherlands to provide support to their QA-department. And while being there it appeared that this company did benefit significantly from the SAP-experience  of our colleague. A second request came from the European headquarters of a biotech company which needed a second external Qualified Person next to their  primary QP to provide for additional capabilities which might be necessary during peak periods or holidays.