9/4/2024 12:29:35 PM Poland - Life Sciences Monthly Brief, August 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...
12/21/2023 9:31:07 AM Our predictions for life sciences in 2024 By DLA Piper Life Sciences As the New Year is fast approaching, we asked members of our international Life Sciences team to share their predictions of what will be...
11/22/2023 4:12:49 PM Global Compliance Guide for Engaging Healthcare Professionals By Jolanta Dabrowicz Andrzej Balicki, Ph.D. Joanna Barker-Wall Pharmaceutical companies rely on the knowledge and expertise of healthcare professionals for purposes such as scientific discussions,...
9/20/2023 9:57:17 AM Sex bias, racial bias and AI – An ESG issue for the life sciences and healthcare sectors By Nicholas Tyacke Greg Bodulovic Alexandra de Zwart Alex Horder Jordan Davis +2 more... Show less It is increasingly important for organisations wishing to be good corporate citizens to have robust policies in place surrounding the...
7/27/2023 8:26:54 AM FDA aims for international harmonization and modernized clinical trials By Bethany Hills Adam Donat The Food and Drug Administration (FDA) has released a draft guidance titled, “Good Clinical Practice (GCP) E6(R3),” explaining how the...
5/19/2023 11:12:27 AM Brazilian Health Regulatory Agency updates regulation that governs requirements for clinical laboratory tests By Bruna Rocha Juliana Marcondes Victoria Cristofaro On May 3rd of this year, Anvisa approved Resolution No. 786/2023 ("RDC 786/2023"), which addresses the technical and health requirements...
4/20/2023 2:20:37 PM Cross-border considerations for privacy in clinical trials - At the Intersection of Sciences and Law Podcast Series By James Clark Paula Gonzalez de Castejón Llano-Ponte David Kopans In this episode of At the Intersection of Sciences and Law Podcast Series, in light of the recent publication of our Cross-border Guide...
4/17/2023 3:43:23 PM ESG Issues: Clinical Trials and Diversity (Racial Bias in Medical Technology) By Nicholas Tyacke Greg Bodulovic Alexandra de Zwart Abi Ketheeswaran Sharon Zhang +2 more... Show less ESG is increasingly a primary focus for companies and consumers alike. Across all industries, companies are under immense scrutiny from...
3/10/2023 3:14:37 PM Poland - Life Sciences monthly brief, February 2023 By Andrzej Balicki, Ph.D. Jolanta Dabrowicz Przemysław Matuszewski Urszula Grębowska +1 more... Show less Download a copy of our January monthly briefing, which covers key updates and insights in the following areas: Medicinal productsClinical...
11/15/2022 11:27:47 AM Clinical Trials and Privacy Matters: A Cross-border Guide By Marco de Morpurgo This week our Life Sciences team published the first edition of its Cross-border Guide to Clinical Trials and Privacy. The Guide will...
4/8/2022 8:16:10 AM Ukraine conflict: Impact on clinical trials By Mariana Ricardo Ana Rita Santos Both the Clinical Trials Coordination Group (CTCG) and the Portuguese National Authority of Medicines and Health Products (INFARMED) have...
4/5/2022 2:04:46 PM The Spanish authorities designate an independent supervisory body to ensure compliance with the clinical trials Code of Conduct. By Elisa Lorenzo After the publication of the Code of conduct regulating the processing of personal data in the field of clinical trials and other...
3/3/2022 4:26:50 PM Incentivizing diverse representation in clinical trials: At the Intersection of Science and Law Podcast Series By Kirsten Axelsen Sarah Schick Diverse representation in clinical trials is critical in achieving greater equity and better healthcare outcomes. In this episode, DLA...
3/2/2022 10:22:08 AM Spain publishes the first code of conduct on the processing of personal data on clinical trials By Elisa Lorenzo Paula Gonzalez de Castejón Llano-Ponte The Spanish Data Protection Commissioner (“AEPD”) has recently approved the “Code of conduct regulating the processing of personal data...
2/18/2022 11:14:19 AM Clinical Trial Regulations in the EU – how will the UK follow? By Kate Black The European Medicines Agency has confirmed that the new Clinical Trials Regulation is now in effect as of 31 January 2022. Please see...
2/2/2022 1:53:31 PM Safety assessment of clinical trials in the EU: how will Member States be involved? By Mariana Ricardo The 31st January marked the day both the EU Clinical Trials Regulation (Regulation (EU) No 534/2014 – “CTR”), and the framework for the...