This quarter we welcomed our new colleague Maarten Bisseling who brings with him significant experience in the Pharmacovigilance domain. He has worked for 8 years as Pharmacovigilance Support Officer and Safety Data Specialist, subsequently in a company marketing generic medicines and a global company distributing innovator medicinal products. He represents the much needed extension of our Pharmacovigilance team, which serves an ever increasing number of pharmaceutical companies in the Netherlands and abroad.
Nuclear medicine and radiopharmaceuticals have been a niche market for our agency ever since its start in 1987. But never we witnessed such a rise in the number of new projects as we did in this quarter. Academic hospitals in the Netherlands are now establishing cyclotron-based manufacturing facilities to be able to provide their patients with extremely short-lived medical isotopes. However, as the competent authorities require such facilities to comply with the European Good Manufacturing Practices (GMP) for medicinal products, these projects require extensive support with respect to the building and validation of such facilities, as well as with the implementation of robust quality systems to safeguard the safe manufacturing of these products. But not only “domestic” projects count to this rise, we also received requests from manufacturing facilities in the Middle-East and Russia to support them with similar projects.
With respect to regulatory affairs we got involved in an interesting project dealing with Class I medical devices. The necessary notification according to the Medical Device Directive of such new Class I devices to the Competent Authority is relatively easy and only requires the presence of a Technical File including a justification for this classification. However, placing advertisements for such Class I devices in media such as television broadcasting and newspapers is quite a different piece of cake. These media then require an approval of the classification by a self-regulating body (KOAG/KAG) which for this purpose hires outside experts. And due to the extremely wide variety of Class I medical devices, chances are your “expert” does not at all prove to be the expert for your particular medical device as the objections we received in this case clearly revealed . Luckily, in such cases you will be allowed a second review by another “expert” and we are eager to learn of this second assessment shortly.