Publication date: November 21, 2024
In recent years, artificial intelligence (AI) and machine learning (ML) technology have begun to play an increasingly important role in the pharmaceutical industry. AI offers the potential to revolutionize the way we produce medicines, leading to significant improvements in quality, efficiency, and innovation. However, introducing modern technologies into the regulated pharmaceutical environment is associated with challenges related to ensuring quality and compliance with applicable regulations. It is in this context that GAMP5 (Good Automated Manufacturing Practice) is one of the most important tools for managing the life cycle of computer systems in the pharmaceutical or biopharmaceutical industry, including systems based on AI.
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Publication date: November 14, 2024
Rapid Alert System for Food and Feed (RASFF)
Under Article 50 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 (OJ EU L. of 2002 No. 31, p. 1, as amended), RASFF was established, a system for notifying direct or indirect danger to human health deriving from food or feed. Thanks to product testing and notifications in the RASFF system, non-compliant products posing a risk to humans are withdrawn from the market. Information is entered into the system on food, feed and food contact materials that are potentially dangerous to human health, animals or the environment and follow-up actions as a result of identifying such products. Due to the type of identified threats that appear in the system, RASFF is an important source of information on product safety. Substances are identified in imported products that, if consumed by humans, may cause serious, negative health effects.
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Publication date: November 14, 2024
Company agreement and freedom of contracts
The company agreement (Articles of Association, shareholder Agreement) is a very unusual type of agreement. It not only creates obligations between the parties, but also creates a completely new legal person – a company. Although the full creation of a company requires other activities, primarily an entry in the National Court Register, the company agreement defines the way it operates, its goals and the shares it consists of. It is for the company what the constitution is for the state.
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Publication date: November 14, 2024
The fall conference of the International Section of the largest American legal organization, the AMERICAN BAR ASSOCIATION, is underway in London: 2024 ILS Fall Conference “100 years of the ABA in the United Kingdom: Tradition , Innovation and Influence”.
As part of the conference-related events , participants are currently admiring one of the certified copies of an English document dated 1215 issued by King John the Landless.
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Publication date: November 14, 2024
Article 45 paragraph 2 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council of 28 January 2002 (OJ EU L. of 2002 No. 31, p. 1, as amended) in addition to the type of information included in the scope of labelling also specifies the media on which this information is provided. It includes both information media that are physically connected with the foodstuff (packaging, label, jacket, leaflet, tag, attached documents) and documents related to the product, but not necessarily directly attached to it (e.g. commercial documents, product specifications transferred in the course of trade between entrepreneurs). Such a broad scope of labelling differs from the traditionally understood labelling of goods, which covers only the information placed on the product itself, its packaging or label. Therefore, product labelling means any action, connection of a given information medium, e.g. a label with a product or service, as a result of which a physical connection is established between the specific medium and the product”. [1]
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