As of February 2023, EMVO’s AMS portal has been available to pharmaceutical companies for processing their alerts. With many functions, a clear presentation, and active user management, it makes the processing of error messages much easier. Since the EU-FMD came into force, alerts have also been a concern for pharmaceutical manufacturers. Recently, there have been […]
November 2023 marks an important date for the US pharmaceutical industry. The final phase of the DSCSA requirements revolves around interoperability and increased supply chain assurance. Verification Router Services (VRS) are one building block to meet the requirements. The DSCSA requires that all trading partners have a secure, electronic, and interoperable system in place for […]
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Pharmaceutical companies in need of a serialization provider are well-advised not to choose one arbitrarily. As an integral part of compliance and possibly years of collaboration, it is important to have a partner with whom you are fully satisfied. This is because, as in any industry, there are quite a few differences between providers. In […]
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In the European Union, medicinal products and medical devices are only approved for the market if manufacturers can guarantee the safety of their products. If adverse events occur after the products have been placed on the market, the vigilance procedures of the respective industries take effect. This is because patient safety continues to be a […]
Despite comprehensive preclinical and clinical studies, it is not uncommon for drug risks to be discovered only after market approval. Possible reasons are a larger patient population, multi-medication, off-label use, or medication errors. The pharmacovigilance department has the important task of identifying, assessing, better understanding and, if necessary, reporting these risks. In this way, a […]
Earlier this year, the European Medicines Verification Organization (EMVO) released its new Alert Management System (AMS) portal to improve the exchange of information between stakeholders in the event of suspected counterfeiting. In addition, the initiated investigations can be tracked and logged more easily with the help of this portal. Due to the pan-European approach of […]
Outsourcing usually evokes negative connotations. We think of jobs being lost and moved abroad because they can be filled more cheaply there. But what about industries where there is a severe shortage of skilled workers and qualified staff is hard to find? This is where Business Process Outsourcing (BPO) comes into play. Complex tasks are […]
In many industries, there is a lack of skilled workers. It means that there are more vacancies than qualified people to fill them. Demographic change, digitalization, and the increasing professionalization of the labor market are often cited as the cause. Many potential employees are simply not sufficiently trained to meet the requirements of the advertised […]
Read More… from Skills Shortage in the Pharma Industry – How We Can Help
In order to make national supply chains in the healthcare system more efficient and secure, Jordan is currently expanding its serialization system. Since 2018, every pharmaceutical product must be provided with a DataMatrix. By 2020, these products should be labeled with a DataMatrix and additionally need to be serialized. However, the deadline has been postponed […]
The Falsified Medicines Directive (FMD) was introduced to prevent falsified pharmaceuticals from entering the market. Part of this is a Track & Trace system that detects these counterfeits so they can be taken out of circulation. If a counterfeit drug does make it into the supply chain, the alerts are used to detect it so […]