19 Dec, 2024 Our Predictions for Life Sciences in 2025 By DLA Piper Life Sciences As the New Year is fast approaching, we asked members of our Life Sciences team to share their predictions of what will be the key issues...
17 Dec, 2024 Spanish Pharmaceutical Industry Strategy 2024-2028: Strengthening Access, Innovation, and Sustainability By Elisa Lorenzo On 10 December 2024, the Spanish Government officially unveiled the Pharmaceutical Industry Strategy 2024-2028 ("the Strategy"), a...
16 Dec, 2024 NIS2 Series, Part 3 - What happens if you don’t comply? An overview of enforcement, supervisory measures, and liability for management bodies By Andreas Rüdiger Philipp Adelberg Introduction The NIS2 Directive (NIS2 or the Directive) introduces extensive new cybersecurity requirements for a wide range of...
10 Dec, 2024 Poland - Life Sciences Monthly Brief, November 2024 By DLA Piper Life Sciences Download a copy of our July monthly briefing, which covers key updates and insights in the following areas: Medicinal products;Medical...
10 Dec, 2024 Life Sciences News in Italy: November 2024 By DLA Piper Life Sciences Regulatory MDCG updates Q&A on vigilance terms under MDR and IVDR On 11 November 2024, the Medical Device Coordination Group (MDCG)...
04 Dec, 2024 What should in-scope organisations do now to prepare for NIS2 compliance? By Cristina Criscuoli Federico Toscani Introduction In our second Network and Information Systems Directive (NIS2 Directive or Directive) article, we discuss the significant...
04 Dec, 2024 DLA Piper Genomics Series: Shaping the Future of Genomics - How Governments Worldwide Are Driving the Shift to Personalised Medicine By Kate Black As our Genomics mini-series has been exploring to date, genomic medicine is rapidly transforming healthcare across the globe, offering...
20 Nov, 2024 EHDS – Access to health data for secondary use under the European Health Data Space By Andreas Rüdiger James Clark This is Part 3 in a series of articles on the European Health Data Space ("EHDS"). Part 1 provides a general overview of the EHDS. Part...
19 Nov, 2024 DLA Piper Genomics Series: The UAE turns to genomics to provide world-class healthcare services By Adam Vause Celia Johnson-Morgan Katie Edwards Harnessing genomic technologies is revolutionising patient care by powering the evolution of personalised and precision medicine. The...
12 Nov, 2024 DLA Piper Genomics Series: CRISPR/Cas patent disputes – the position in Australia By Nicholas Tyacke Alex May The development of Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)/CRISPR-associated protein (Cas) systems for genome...
05 Nov, 2024 Poland - Life Sciences Monthly Brief, October 2024 By Andrzej Balicki, Ph.D. Jolanta Dabrowicz Przemysław Matuszewski Urszula Grębowska +1 more... Show less Download a copy of our July monthly briefing, which covers key updates and insights in the following areas: Medicinal products;Medical...
31 Oct, 2024 Medicines Australia Code of Conduct – New Edition Released By Nicholas Tyacke Greg Bodulovic Alexandra de Zwart Hazel Pang +1 more... Show less On 30 October 2024, Medicines Australia (MA) formally adopted a new edition (Edition 20) of the MA Code of Conduct (MA Code), which will...
31 Oct, 2024 DLA Piper Genomics Series: From Gene-Edited Plants to Gene Drives: Unpacking Regulatory Debates By Mikael Kurki Pia Riemenschneider Lisa Weinekötter In this two-part article, we delve into the complexities of gene editing in plants and the ongoing EU legislative debates, followed by an...
29 Oct, 2024 UK DHSC seeks circular approach to medtech By Richard Taylor Nathan Davis The UK's Department of Health and Social Care (DHSC) has published its "Design for Life" roadmap towards a circular approach to medtech...
28 Oct, 2024 NIS2 Series, Part 1 - Key features of the EU's new cybersecurity law and how it will apply to the life sciences sector By Nicholas de Lacy-Brown Abstract: The EU has expressly recognised the criticality of the life sciences sector by bringing pharmaceutical manufacturers, clinical...
24 Oct, 2024 DLA Piper Genomics Series: Navigating Regulatory Challenges in the Era of Cell and Gene Therapies By Marion Abecassis Lyndsey Hudson Nicola Landolfi Ranulf Barman Marion de Galembert +2 more... Show less As healthcare moves towards personalised and precision medicine,[2] cell and gene therapies (CGTs) have emerged as cutting-edge and...