Regulatory compliance is a crucial topic for pharmaceuticals because they have to comply with various regulations and requirements that undergo changes and updates. We make a brief overview and point out the highlights of 2021. Moreover, we turn our sights on the upcoming regulations and updates. Starting...
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Regardless of the pandemic, the pharmaceutical industry and the processes in it are progressively developing and taking new directions in 2022. We are welcoming 2022 with positive expectations and more substantial confidence that this year will bring the expected benefits for all businesses. In 2021, the...
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All terms regarding DSCSA that you need to know are here: ADR Authorized Distributor of Record. A wholesale distributor that a manufacturer designates or authorizes to distribute its products. ASN Advanced Ship Notice. A notification of pending deliveries, usually in an electronic format. ASN is the common name for...
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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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If you want to learn in details and understand the new Track & Trace requirements regarding medical devices - this is your event! Medical Devices Regulation (MDR) is a real hot topic amongst the supply chain participants. It completely changes the legislation and business processes regarding...
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