Publication date: November 29, 2024
The importance of artificial intelligence in creating new drugs
Artificial intelligence is increasingly used in research on the search for new drugs. Pharmaceutical companies are investing in AI programs that will allow for the production and introduction of new drugs to the market more efficiently. Studies show that the market for artificial intelligence in the process of discovering new drugs will increase fivefold in 5 years [1]. The efficiency of this technology should also be addressed. Boston Consulting Group has prepared a report on the issue of the number of active molecules discovered by AI [2]. The authors of the review confirmed that thanks to artificial intelligence, a doubling of the overall productivity of pharmaceutical research and development can be expected. It should be remembered, however, that the molecules discovered by AI are still in the testing phase, but the results are satisfactory so far. Due to the growing popularity of using AI in this way, legislators must regulate these issues in generally applicable laws. Lawmakers in the United States and the European Union are introducing new regulations regarding the regulation of AI systems. This may have a significant impact on the production of medical devices and their admission to trade.
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Publication date: November 28, 2024
Introduction
The IP Box (Innovation Box) relief is one of the tools introduced to the Polish tax system to support research, development and innovation activities. Since 2019, Polish entrepreneurs, including individuals conducting business activities, can benefit from a preferential tax rate of 5% for income obtained from qualified intellectual property rights. This solution is of particular importance for the dynamically developing IT industry, in which the work of programmers often generates qualified income, for example from copyrights to software.
However, the IP Box relief raises many interpretation controversies, especially in relation to the definition of qualified intellectual property rights and documentation obligations. In practice, taxpayers often encounter difficulties in separating income covered by the relief and meeting the requirements for maintaining detailed records. An additional challenge is the application of the relief in the context of international cooperation, especially in the case of Polish programmers implementing contracts with foreign companies.
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Publication date: November 21, 2024
The risk analysis should take into account real threats to data processing and properly estimate their level. Risk analysis cannot be a superficial activity performed solely to meet the formal requirements of the personal data protection regulations, because then it does not function as an effective way to minimize threats – learnings from the most current decision of the Polish Office for Personal Data Protection imposing a fine on a medical company undergoing ransomware attack.
Introduction
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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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