The withdrawal of the United Kingdom from the European Union had an impact on the rules on the flow of personal data. From that point on, the UK became a third country as defined in the GDPR, the consequence of which – among other things – was intended to limit the free flow of personal data to and from the EU. However, this has not happened. Initially, on December 24, 2020, UK and EU representatives signed a Trade and Cooperation Agreement (TCA) that allowed the free transfer of personal data from the UK to the EU 6 months longer.

New decisions of the European Commission

This year the European Commission has adopted two implementing decisions finding an adequate level of protection for personal data in the UK: implementing decision dated 28.06.2021 in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council on the adequate protection of personal data by the United Kingdom and implementing decision of 28.06.2021 in accordance with Directive 2016/680 of the European Parliament and of the Council on the adequate protection of personal data by the United Kingdom.

More

KIELTYKA GLADKOWSKI KG LEGAL constantly supervises and prepares its lawyers for the specialization in which they provide services for foreign clients. In order to systematize the conceptual grid of very specialized fields of IT, fintech, blockchain, KIELTYKA GLADKOWSKI conducts internal consultations to improve the experience of our lawyers specializing in legal assistance for foreign clients from the IT and TECH sector. As a result of such internal research, KIELTYKA GLADKOWSKI creates and publishes texts on topics related to modern legal problems, but also to explain the basic concepts of specialized technology and IT fields. In this way, KIELTYKA GLADKOWSKI aims to demonstrate to potential clients within specialized industries that our lawyers are also familiar with specialist terms necessary for a proper understanding of our foreign client’s business and legal needs, especially in relation to clients operating in all sectors of production with the use of blockchains as well as supply chains using blockchains.

This is one of those texts. We invite you to read it.

BLOCKCHAIN TECHNOLOGY APP IN FINTECH AND FOOD SUPPLY CHAIN IN THE TIMES OF GLOBALISATION

More

On 20 October 2021 KIELTYKA GLADKOWSKI will take part in 20TH EDITION OF CEE INDUSTRY LEADERS EXPO for E-COMMERCE. The event is dedicated for online sellers in Poland.

The fairs will consist of case studies, presentation of services and analysis of the market. Some of the topics discussed by the panelists will include: InPost Fulfillment; Shipping to the Czech Republic, Slovakia, Hungary, Romania, Bulgaria, Greece; How to increase sales thanks to Ceneo; Real Time Bidding auctions; SXO or UX + SEO in generating sales; Maximizing sales on Amazon; New rules in Poland for calculating VAT in E-commerce; Machine Learning at tantis.pl; Progressive Web Apps – an online store available anytime and anywhere.

More

The team of KIELTYKA GLADKOWSKI dedicated to clients operating in life science sector actively advises on all aspects of in vitro diagnostics, including regulatory, corporate and investments matters. For the purposes of such clients this text analyses the bullet points 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. Regulation 2017/746/EU (IVDR) replaces the existing Directive 98/79 / EC on in vitro diagnostic medical devices (IVDD), which was adopted in 1998.

With the publication of the IVDR, the five-year transition period from the In Vitro Diagnostic Medical Devices Directive (98/79/EC) (IVDD) to the new regulation has started. The IVDR regulation will apply from the date of application, i.e. from May 26, 2022, with some provisions, including Notified Bodies and the Medical Device Coordination Group will enter into force sooner. Until the date of application of the IVDR, the laws and regulations adopted by the Member States under the IVDD will continue to apply. Under Art. 22 of the 1998 IVDD directive, the member states were obliged to prepare and introduce the national laws, regulations and administrative provisions necessary to comply with this directive by December 7, 1999 (IVDD) at the latest. The provisions of the directive were to apply with effect from 7 June 2000. As the provisions of the directive could be interpreted differently in different countries, it was possible for national provisions to differ. In the case of EU regulations, the provisions contained therein do not have to be transposed and adapted to national law. In May 2017, the European Parliament and the Council of the European Union published two new regulations on medical devices (2017/745/EU) (MDR) and in vitro diagnostic medical devices (2017/746/EU) (IVDR). Regulation 2017/746/EU (IVDR) replaces the existing Directive 98/79/EC on in vitro diagnostic medical devices (IVDD), which was adopted in 1998.

More

KIELTYKA GLADKOWSKI is proud of the fact that we advise on regulatory matters concerning the most modern pharmaceuticals and therapies in the world, including those related to cell and gene therapies. We work for our corporate clients at all stages of their development, from inception to IPOs.

We try to broaden the knowledge necessary to understand the needs of our clients. An example is the analysis of a report concerning the market and novelties of gene and cell therapies in the United States. The purpose of this article is not to describe specific diseases, but for the purposes of legal services, we focus in such analyses on technologies and types of state-of-the-art therapies.

We invite you to read the text containing specific examples, names of therapies, companies, etc. This text is based on the report prepared by the STAT organization, which is a premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. They focus on policy developments in the US, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. The entire report can be reached here:

The future of cutting-edge gene and cell therapies is changing novel approaches and changing the trajectory of treating cancer, lethal genetic diseases and other devastating diseases. But these innovations also come with their own set of challenges, including access issues. The high prices of such therapies, which have entered the market in recent years, and the expected high development costs of others, raise questions about how healthcare systems, payers and patients will pay for treatment.

FDA approves the first personalized cell therapy for patients with: Multiple myeloma.

More