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.
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.
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.
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).
“Medical Cannabis in Poland” – this is the topic of the presentation for the “Food, Agriculture, and Cannabis Committee” meeting of ABA on 15th February 2024.
