The concept of a named patient concerns the access to the supply of a medicinal product that is excluded by a Member State from the provisions of Directive 2001/83/EC, in accordance with the applicable provisions and in order to meet special needs [based on Article 5(1) of 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 (OJ EU L 311, 2001, No. 311, p. 67, as amended)].
On Thursday, October 10, KIELTYKA GLADKOWSKI KG LEGAL will take part in the meeting at the Life Science Cluster with SELVITA, on “Deciphering the Code of Drug Discovery: Application of Machine Learning in Designing Compound Libraries”. The meeting will be hosted by the leading Polish biotechnology company Selvita, including a Senior Machine Learning Specialist, responsible fordevelopment of the proprietary TADAM model (Target- Aware Drug Activity Model). This is a deep machine learning model that allows for efficient high-throughput virtual screening. This model has a significant advantage over other existing solutions on the market – it is much faster and more accurate in the analyses performed, and also achieves state-of-the-art results, enabling the creation of combinatorial library subsets targeted to a specific biological target. Studies of such sets significantly increase the probability of identifying the right active compounds, which is crucial for drug development. Additionally, a separate model has been developed to predict the optimal conditions for the amidation and Suzuki reactions. This facilitates the synthesis of the targeted libraries described above using appropriately arranged catalysts, reagents and solvents for optimal performance based on substrates.
The NANDO (New Approach Notified and Designated Organizations) database is an indispensable tool for every sponsor or investor who wants to legally introduce their products to the European Union market.
NANDO constitutes a list of notified bodies authorized to issue documents confirming compliance with EU regulations. Notified unit is an organization appointed by EU Member State (or other countries under specific agreements) to assess the compliance of certain products with the regulations before placing them on the market. As the name NANDO suggests, it refers to all organizations in the European Union notified and designated by the European Union under the political concept called “New Approach” and “New Approach Framework”. This covers a wide range of products, including toys, personal protective equipment and diagnostic devices.
In vitro diagnostic medical devices are intended for testing samples taken from the human body. This test is carried out outside the human body (in vitro) in laboratory conditions, as well as at home, in the case of products intended for self-testing. In accordance with the definition contained in Art. 2 point 2 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ EU, L. of 2017, No. 117, p. 176, as amended) (hereinafter: IVDR) medical device is a device that is a reagent, reagent product, calibrator, control material, kit, tool, instrument, hardware, software or system, whether used individually or in combination, intended by the manufacturer to be used in vitro for the examination of samples obtained from the human body, including blood and tissue obtained from donors, solely or principally for the purpose of providing information:
about a process, physiological or disease state;
congenital physical or mental developmental defect;
predisposition to disease or illness;
to determine safety and compatibility with potential recipients;
