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KIELTYKA GLADKOWSKI KG LEGAL IS A PROUD CONTRIBUTOR TO CHAMBERS AND PARTNERS GLOBAL PRACTICE GUIDE LIFE SCIENCES 2025
Publication date: April 07, 2025
KIELTYKA GLADKOWSKI has made a contribution to new edition of Chambers and Partners Global Practice Guide Life Sciences 2025, where our lawyers provided insights into:
Polish Healthcare Cybersecurity
Use of Artificial Intelligence in the Life Sciences Sector, including the use of AI in clinical trials and pharmacovigilance
Good Automated Manufacturing Practice (GAMP) 5 guidelines
New EU and Polish provisions on Medical Device Conformity Assessment
Problems Encountered by Foreign Drug Manufacturers Conducting Clinical Trials in Poland, including problems with compassionate use and extended access procedures
Access to Medicinal Products for Patients, including greater information requirements, e-prescriptions
New regulations on Medical Cannabis (pharmaceutical raw material, online platforms, online consultations)
Regulations on the sale of over-the-counter (OTC) drugs, in pharmacies and multi-sector stores
New Regulations for Health Apps (Digital Therapeutics) and possibilities to obtain Ministry of Health Certified Apps
Food and nutrition safety regulations, the supervision of the Chief Sanitary Inspectorate and the RASFF database.
Investments in the Life Sciences Sector in Poland and Financing Models