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Dark place for scams and frauds

Publication date: February 26, 2024

Place where the sun does not shine – Darknet

To write and explain what Darknet Markets are and where we can find them first we need to get familiar with darknet.

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Issuing authorization for a clinical trial of a medicinal product – practical tips under EU and Polish law

Publication date: February 26, 2024

Given the current medical standards, the birth of a new medicinal product (drug) can only become a fact as part of a long-term and expensive research and development process. Such a process carries a high risk of failure. Typically, the research and development process takes many years and its effectiveness is low. However, such research is undoubtedly needed.

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VALUATION OF SHARES AND STOCK IN RESTRUCTURING PROCEEDINGS IN POLAND – PLEDGED SHARES AND PRIORITY RIGHTS OF PLEDGEE

Publication date: February 21, 2024

An important issue in the restructuring process, practical for creditors from the point of view of making decisions in restructuring and bankruptcy proceedings, is the valuation of the assets of the entity subject to restructuring, taking into account individual classes of assets. We may be dealing with a valuation of the entire enterprise or individual components. In Poland, company valuation and the process related to it have not been legally regulated. At the restructuring stage, the bankruptcy trustee or liquidator – depending on the form of proceedings – estimates the components of the bankruptcy estate, and may use experts to that purpose.

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KIELTYKA GLADKOWSKI KG LEGAL – SPEAKERS AT AMERICAN BAR ASSOCIATION JOINT COMMITTEE MEETING OF TIPS MEDICINE & LAW INTERNATIONAL SECTION INTERNATIONAL LIFE SCIENCES AND HEALTH, AND INTELLECTUAL PROPERTY SECTION LAW PRACTICE MANAGEMENT

Publication date: February 21, 2024

On 20 February 2024, Malgorzata Kieltyka and K. Jakub Gladkowski had the honour and great pleasure to be speakers at the American Bar Association Joint Committee Meeting of TIPS (Tort, Trial and Insurance Practice) Medicine & Law International Section International Life Sciences and Health, and Intellectual Property Section Law Practice Management.

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EU Health Data Space and EU Data Act and Clinical Trials Regulation

Publication date: February 21, 2024

In this presentation prepared for the American Bar Association Joint Committee Meeting of TIPS (Tort, Trial and Insurance Practice) Medicine & Law International Section International Life Sciences and Health, and Intellectual Property Section Law Practice Management we are going to focus on three aspects. First – case study of medical device litigation; secondly – we are going to discuss the legislative landscape of data legislation in European Union and as third part, we are going to discuss the most crucial assumptions implemented by the of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16th April 2014 on clinical trials on medicinal products for human use, with a particular emphasis on the Clinical Trials Information System (CTIS).

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