As the end of the year is coming, it is time to look at the trends in pharma manufacturing for 2022. The expected volume that the Pharma industry will reach next year is $1.5 trillion. Despite the COVID-19, this industry is constantly investing in digitalization, developing...
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Uzbekistan is one of the countries in the CIS region that work quite proactively on improving the quality of healthcare in different stands and developing traceability system. The Ministry of Health of the Republic of Uzbekistan's governmental body participates in implementing programs regarding the licensing of...
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The government of Kazakhstan is working on the implementation of a pharma track & trace for the serialization of all medicines In 2018, the journey of Kazakhstan towards building a traceability system started. In the next 3 years, the government constantly worked and planed the pharmaceutical...
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Key areas of DSCSA`s new requirements The announcement that FDA officially confirmed the DSCSA 2023 Interoperability Deadline is a hot topic. The new requirements affect different aspects of track and trace process and meantime challenge all supply chain participants. Now is the time to meet the...
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Interoperability - the road towards Connected Healthcare If you are in the pharma world, we are sure that you meet the word “interoperability” at least once a day. Definitely, this term became trendy, especially over the past year regarding the new DSCSA requirements. However, we should...
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28th April 2022 is the official deadline for meeting Track & Trace requirements as the Brazil Health Regulatory Agency (ANVISA) has approved its final Normative Instruction (NI 100). The date is set and all pharma supply chain participants have just 6 months from now to...
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Key challenges in front of cloud services that you have to take into account According to research in 2022, the global public cloud services market is expected to grow by approximately 22%, which amounts to about 482 billion U.S.D. Moreover, focusing on the pharma industry, the...
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Organizations that start implementing traceability can begin to take advantage of the radically increased insight and control they have over how their products are manufactured and distributed. We have been already discussed the fundamental impact of traceability systems on the different industries and the various supply...
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Master UDI-DI - the new EU requirements in regard to medical devices With the implementation of the Medical Devices Regulation (MDR), it became apparent that manufacturers should assign UDI to medical devices. This is intended to allow the identification and to improve the traceability of devices,...
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The fourth revolution has already occurred in manufacturing. Industry 4.0 is a fact, and the different industries must focus on adapting the new technologies in their processes. The new technology revolution will and has indeed already affected businesses. Take a look at its impact on the...
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The sustainable environment is a subject under consideration for all participants in the supply chain for a long time. We outlined the key first “green steps” from the Pharma industry in our free whitepaper. They could be the beginning of the road towards environmentally friendly manufacturing...
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When we mention the topic “traceability”, the term “visibility” comes automatically in our minds It`s normal because the idea behind the implementation of track & trace systems is to be achieved a real-time view of the supply chain, by which the route of the products could...
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What were the expectations of serialization? What did happen in reality? We have discussed serialization`s challenges before and we could definitely say that because of their diverse nature and different level of difficulty, the individual supply chain participants adapt and deal with them in various ways....
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Yes, traceability is a “must” nowadays. In recent years people and industries have put trust in track and trace systems for the good of the whole supply chain. The definition for traceability is simple – the process of tracking the origin and the whole way of...
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"There are no plans to extend the 2023 deadline for enforcing the interoperability requirements" said Leigh Verbois, director of FDA’s Office of Drug Security, Integrity and Response at the Center for Drug Evaluation and Research. The US Food and Drug Administration is working “full tilt” towards implementing...
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The International Coalition of Medicines Regulatory Authorities (ICMRA) released a report which provides technical recommendations, strongly focused on interoperability. The document is drawn up by the ICMRA in cooperation with WHO (World Health Organization). The referred recommendations are continuation of ICMRA`s 2017 paper, which analyzed...
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EU MDR`s impact on legacy medical devices Medical Devices Regulation (MDR) completely changes the legislation and business processes regarding the production and distribution of medical devices. We have already considered the topic of MDR`s changes and requirements, but not the impact on the legacy medical devices. In...
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How to evaluate a cloud service provider? Cloud services are not already a “tabu” for the pharma industry. In fact, despite the established notion that the pharmaceuticals prefer services and solutions that are on-premises, nowadays they are strongly focused on using new technologies. The innovative solutions...
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The widespread development of technology, together with the effects of the pandemic, has drastically changed the behavior of the pharmaceutical industry. According to a recent survey, we’ve conducted, 67% of pharmaceutical companies had to shift their plans for digital transformation in 2020 due to the COVID...
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EMDN - principles, structure, access EMDN (European Medical Devices Nomenclature) is the official nomenclature, established by the European Commission for use for registration of medical devices by manufacturers in the EUDAMED database. The very first version of it was released on 4th May 2021. In general,...
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