Nov 15, 2022 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...
Apr 08, 2022 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...
Apr 05, 2022 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...
Mar 03, 2022 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...
Mar 02, 2022 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...
Feb 18, 2022 Clinical Trial Regulations in the EU – how will the UK follow? By Kate Burgess The European Medicines Agency has confirmed that the new Clinical Trials Regulation is now in effect as of 31 January 2022. Please see...
Feb 02, 2022 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...
Jan 31, 2022 New EU Clinical Trial Regulation to take effect from today By Marco de Morpurgo Carlotta Busani Today, the new EU Clinical Trials Regulation (Regulation (EU) No 534/2014 – “CTR”) becomes applicable. The CTR introduces a unified...
Jan 26, 2022 Initiative launched to accelerate EU clinical trials (ACT EU) By Lyndsey Hudson Accelerating Clinical Trials in the EU (ACT EU) was launched a few days ago, with the aim of transforming the way in which clinical...
Oct 08, 2021 Key takeaways from the ABPI Clinical Research Report 2021 By Richard Taylor Elinor Cavil The ABPI (Association of British Pharmaceutical Industries, the UK trade association for producers of prescription medicines) launched...
Oct 07, 2021 New Clinical Trial Rules in the EU: A Practical Overview of the Upcoming Regulation By Marco de Morpurgo Carlotta Busani With the upcoming application of the new EU Clinical Trials Regulation (‘CTR’), the conduct of clinical trials in the European Union...
Sep 10, 2021 Clinical trials conducted pre-application can cause enabling disclosure By Richard Taylor Elinor Cavil In a recent webinar titled “Protecting Medical Devices in Europe – Avoiding Common Pitfalls”, Kieran Killough (Partner at HGF) pointed to...
May 26, 2021 Spain: Leading country in the field of clinical trials By Elisa Lorenzo Andrea Fernandez Last Thursday, May 20, Clinical Trials Day was celebrated all over the world. For the occasion, the National Business Association of the...
May 17, 2021 Poland: Draft bill on Clinical Trials By Amelia Prawda Andrzej Balicki, Ph.D. On 30 April 2021, the draft bill on clinical trials of medicinal products for human use (the “Draft bill”) was published. It intends to...
Feb 16, 2021 An ever-changing landscape - European regulator looks to speed up authorisation process for modified vaccines addressing COVID-19 variants By Kate Burgess At a time where drug makers are taking action to develop modified versions of their vaccines in order to address the evolving variants of...