Product Safety in Pharma & MedTech

product safety pharma

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 […]

Read More… from Product Safety in Pharma & MedTech


Pharmacovigilance

Pharmacovigilance

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 […]

Read More… from Pharmacovigilance


BPO Example: Alert Management System

Alert Management System

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 […]

Read More… from BPO Example: Alert Management System


Skills Shortage in the Pharma Industry – How We Can Help

Skills shortage in pharma

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


Pharma Serialization in Jordan

Pharma Serialization Jordan

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 […]

Read More… from Pharma Serialization in Jordan


EMVO’s AMS Portal

AMS-Portal EMVO

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 […]

Read More… from EMVO’s AMS Portal