The use of AI and machine learning solutions in drug manufacturing technologies with the use of machine learning and quantitative, high-throughput in vivo experiments; the EU regulations for advanced therapy medicinal products (ATMP) and the procedures for placing the most modern drugs on the world market by the European Medicines Agency.
The intensive development of medicine affects the
medical regulatory law in the European Union, which should cover more and more
new legal problems related to the increasingly common application of advanced
solutions of artificial intelligence, machine learning, telemedicine solutions
and cyber solutions to the technology of manufacturing medicinal products.
In the current legal status, however, the legality of
the use of such state-of-the-art AI and machine learning technologies in pharmaceutical
production should be assessed on the basis of the regulations on the assessment
of their final effect, i.e. the level of admissibility of placing ready-made
alternative therapy products on the market, as well as the legal aspects of
commercialization of such technologies.
On May 20, 2021 KG Legal Kiełtyka Gładkowski attended the live webinar “Disputes In Space: Mediate and Arbitrate” organized by ITechLaw organization.
The main topic of the event will be the discussion on resolving customer disputes and issues in a thriving aviation industry. The experts will discuss the issues of out-of-court settlement of disputes in order to work out the most advantageous solution for the client.
On May 18 and 19, 2021 KG Legal KIELTYKA GLADKOWSKI is participating in the Global Forum on Economic Recovery organized by the US Chamber of Commerce, bringing together government and business leaders to discuss combatting the pandemic and the opportunities and impediments to a dynamic global recovery.
The global pandemic created an unprecedented economic and health crisis for the United States and the world. While the rapid development and deployment of vaccines offers hope for a robust economic recovery in the United States, the pandemic highlighted the need for strong U.S. leadership on the international stage to reinvigorate growth, strengthen trade and build resilient supply chains to support a global recovery. Investing in U.S. competitiveness and joining hands with our allies and partners, will be critical to build a better and more inclusive future – creating healthier communities, supporting entrepreneurship, and expanding access to innovative technologies.
A roundtable discussion among experts was held on 14 May 2021, which addressed the potential and challenges of dispute resolution for blockchain-based transactions.
This was the fourth event in the inaugural series organized by the SVAMC Initiative on Arbitration, Mediation and Blockchain-based Transactions.
Laboratory research in science and medical setting.
The 26th of May 2021 will mark the first day that the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (later ‘Regulation 2017/745’) will fully apply after the 4 years transitional period. This regulation concerns medical devices – that are also regulated in Poland in the Medical Devices Act of 20 May 2010 (later MDA).
Medicinal Products, on the other hand, are regulated in Poland in the Pharmaceutical Law Act of 6 September 2001 (later PLA). Medicinal products are also regulated by the Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (later ‘Directive 2001/83/EC’) and the Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (later ‘Regulation 726/2004’).
Article 117 of the Regulation (EU) 2017/745 introduces significant changes for some combination products.
