Successful meeting on serialization of the ISPE Project Management Community of Practice Benelux


During the meeting which was organized by the International Society of Pharmaceutical Engineering (ISPE), approximately 60 leaders from the pharmaceutical industry, the government, and (mechanical) engineering- and consultancy companies came together and discussed the topic of serialization. 

The meeting, held in Breda (the Netherlands) started with an update from the NVMO (Dutch Association for Medical Education) which facilitates the implementation of the Falsified Medicines Directive (EU2016/161) in the Netherlands. It was concluded that many pharmacies are not going to ready to live up to the directive at the implementation date of February 9, 2019. So far only 1,500 out of 2,600 pharmacies have registered. This could have a big impact since it is obligatory for pharmacists to comply with the directive to continue their business.

In the second presentation an overview of serialization was given by Pharmaceutical Specialist, Adriaan van Loon of Bilfinger Tebodin. Serialization was discussed from multiple points of views (the government, the industry and the patient). Yearly, approximately 1 million people die from the use of falsified medicines. This is about the same as the amount of people that yearly die on Aids/HIV or by car accidents. It is clear that serialization amongst others will lead to increased transparency and traceability, delivery of high quality products to customers and reliable and consistent transfer of information. This all helps to ensure the right product, dosage, route to the patient and time to the patient and enables accurate identification of products and adverse events reporting and will thereby lead to a decreased number of deaths caused by falsified medicines.

To conclude the session, two representatives of global pharmaceutical companies Amgen and Teva reported on the lessons learned while implementing the new guideline. These companies have multiple production sites and sell multiple products in different markets. In their presentation they showed the complexity of implementation of the new guideline for large companies.

We look back on a successful event in which knowledge was shared and interesting people were met. If you have any questions about serialization, please contact Adriaan van Loon: email:, phone: +31 6 21 50 67 97. 

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