This quarter marks the long awaited appearance of the new EU-Guideline for the Good Distribution Practices for medicinal products. Published on March 7 2013 , and subject to a 6-months transition period, this guideline will oblige all European pharmaceutical wholesalers and logistics service providers to adapt, or more precisely to extend, their quality systems and to include the new elements present in this guideline. The two major extensions regard the need for risk management of the operational process as well as a more strict control of transport conditions.
Another milestone this quarter was the approval of our waiver application for a Pediatric Investigational Program regarding a new medicinal product of one of our clients to be registered through the EU Centralized Procedure. Not an easy, and above all a very expensive, procedure for a small company like this one. Luckely enough the European Medicines Agency (EMA) runs a special program for procedural support and cost-reductions aimed at small and medium-sized enterprises (SME’s) enabling such companies to register their newly developed pharmaceuticals through the EMA which otherwise would be virtually impossible.
And, like always, there were sad moments during this quarter as one of our highly valued consultants, Harald Kistemaker, was made an offer he couldn’t refuse by a client for which he was running a project since October 2012. He served our company, and our clients, well for over 8 years but on March 1 we waved him goodbye. Surely, this is not the first time we lost a consultant to a client but that is an inevitable “adverse event” of any consultancy business. It proves at least that we are able to establish good matches between the needs of our clients and the competences of our consultants.