The pharmaceutical industry is fast-moving and unforgiving. Any downtime - from a system failure, cyberattack, or power outage - can disrupt operations, delay shipments, and put compliance at risk. Disaster recovery isnโt just a safety measure. Itโs an essential tool to protect your operations, reputation, and...
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Reliability in pharmaceutical operations isnโt just about keeping things runningโitโs about safeguarding trust, compliance, and delivering life-saving medicines. When downtime strikes, the stakes are high: production halts, critical data risks corruption and compliance with strict regulations becomes jeopardized. This is where Azure Disaster Recovery steps in,...
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At the end of November, the Authorities in Armenia released the Government Decree #1715 on the Implementation of a Pilot Project for Marking of Medicine. Pilot Project Overview The scope of the Pilot project covers pharmaceutical products and vaccines. The starting date of the project is 31...
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November has been an exciting and productive month for SoftGroup, filled with significant achievements, insightful content, and industry engagement. From launching a new whitepaper to exploring pivotal regulatory changes, weโve stayed at the forefront of pharmaceutical serialization and compliance. Hereโs a detailed look at what...
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Serialization Compliance in Greece: A Guide to HMVO and Medicines Verification Stay ahead in the fight against counterfeit medicines with our comprehensive whitepaper, Serialization Compliance in Greece: A Guide to HMVO and Medicines Verification. This resource is designed to help pharmaceutical companies understand and navigate the...
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The pharmaceutical industry relies on trustworthy data at each step of its operations. Why? All stakeholders are named โkeepersโ of patient safety since they meet the strict regulatory standards. Here it comes the role of data integrity. Data integrity is a cornerstone of the pharmaceutical industryโs...
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It is not the first time we will declare that the events are a fundamental part of the business, providing memorable experiences that drive real business results. During the last 30 days, our team participated in three of the top events for the Pharmaceutical industry...
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Latest Updates, November 2024 Starting January 1, 2025, the UKNI Medicines Verification System (UKNI MVS) will permanently close. This closure will mark a significant shift in Northern Irelandโs pharmaceutical landscape. The decision, brought in the Windsor Framework and implemented by Regulation (EU) 2023/1182, will end all...
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In August FDA issued documents for the official extension of DSCSA in order to support the trading partners in meeting upcoming requirements. Furthermore, in October, theย FDA issued an exemption from the enhanced drug distribution security requirements for certain eligible trading partners. Discover the exemptions and...
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In the rapidly evolving pharmaceutical industry, compliance with stringent regulations is crucial to protecting patient data, safeguarding intellectual property, and ensuring seamless business continuity. SoftGroup, as a leader in software solutions tailored to the pharma industry in achieving track and trace compliance, leverages Microsoft Azureโs...
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The Bulgarian Institute for Standardization (BIS) together with GS1 Bulgaria and SoftGroup AD are organizing a second information session on the topic "Digital Product Passport ", which will be held hybridly on October 28, 2024 at 3:00 p.m. in Hall A, Iskar Street 9, 1058...
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The pharmaceutical market of Vietnam is experiencing rapid growth due to increasing demand for healthcare services and a growing middle class. In 2024, the projected revenue in Vietnam's Pharmaceuticals market is estimated to reach USD 2,401.00 million, as the largest segment is the prescript Oncology...
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This is your event if you want to understand what is up to you regarding the mandatory labelling requirements for the Azerbaijan market! The Track & Trace in Azerbaijan is one of the most prominent topics in the Pharma industry this year. Back in Q3 of...
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Referring to information from EMVO, it was announced that the UKNI National system will be disconnected as of 1 January 2025. Therefore, OBPs will not be able to upload GB single-market packs after this date. After 31 December 2024, the EU Hub will send an error...
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SoftGroup is a Sponsor of the 3rd International Congress and Exhibition Pharma Uzbekistan & Central Asia 2024 We eagerly anticipate meeting you at the Pharma Uzbekistan & Central Asia Congress and Exhibition where SoftGroup is a Bronze sponsor this year. The event will take place on...
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We are proud and delighted to stand by GS1 and support it as a Sponsor of the GS1 Healthcare Conference for another year in a row. The conference will take place online from 5-7 November 2024, bringing together healthcare professionals from around the world for a...
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A brief overview of the wholesalers` obligations regarding verification and traceability according to EU FMD requirements. What is a designated wholesaler? A designated wholesaler is a company (sales affiliate/licensee/co-marketer and holder of a wholesale distribution authorization), designated through a license/agreement with the Marketing Authorization Holder (MAH) to...
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The leaflet is an integral part of any medicine. Moreover,ย according to the EU Legislation, it is obligatory to include a package leaflet with all medicinal products, unless all the information required is directly conveyed on the packaging. However, the pharma supply chain and its...
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At the beginning of the month, an official decree was released by the Cabinet of Ministers of the Republic of Azerbaijan on approval of the "Regulation on the system of tracking and tracing of medicines". Here are the outlines of the DVTISโ Azerbaijan Track &...
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Understand completely what is up to you regarding the mandatory pharma track and trace requirements for Italy. Are the upcoming mandatory track and trace requirements in Italy a hot topic for you? If the answer is YES - this is your event. If the answer is NO...
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