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.

The prestation and discussion was divided into three parts:

FIRST PART – related to the discussion and practical analysis of a case study of medical device litigation of cross border character, with a focus on litigation strategy, burden of proof, evidence proceedings, jurisdiction and litigation strategies.

SECOND PART – analysed the new EU legislative landscape on data provisions, including health data, namely EU Data Health Space and EU Data Act, particularly from the perspective of legal and regulatory consequences and duties for the manufacturers of medical devices and other health devices (wearables).

THIRD PART – concerned 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) – the backbone for harmonising the submission, assessment, and supervision processes for clinical trials.