31 Mar 2022 HealthTech - Shifting Landscapes Series (Part 2): Software as a Medical Device By Hannah Gardiner, Eliza Saunders
17 May 2022 Digital Health Transformation: The new Brazilian law on digital drugs leaflets By Bruna Rocha, Juliana Marcondes, Victoria Cristofaro Yesterday morning (12), the Brazilian Federal Government approved Law n. 14,338/22, which results from a bill of the Chamber of Deputies...
17 May 2022 Patent term extensions and infringement proceedings in Australia, and the standing of an exclusive licensee By Nicholas Tyacke, Alexandra de Zwart, Sarah McKenzie For pharmaceutical companies, patent term extensions (PTEs) remain a fundamental means of compensating them for the erosion of the terms...
16 May 2022 Innovation, strategy and collaboration aplenty at the LSX World Congress 2022 By Lyndsey Hudson It was really fantastic to attend the LSX World Congress 2022 in London on 10th and 11th May. So many excellent conversations to be had...
11 May 2022 Telehealth is Brazil: The Bill goes to the Senate and the Federal Court of Medicine regulates the practice of telemedicine By Bruna Rocha, Juliana Marcondes, Victoria Cristofaro On April 27th, Bill n° 1998/20 was approved by the Brazilian Chamber of Deputies of Brazil is currently awaiting approval by the Senate....
28 Apr 2022 What FDA Expects From Medical Device Cybersecurity Efforts By Jae Kim, Raymond M. Williams This article was first published in Law360In recent years, the threat of cybersecurity attacks has evolved in the minds of the public and...
25 Apr 2022 Poland: new medical devices law By Amelia Prawda, Jolanta Dabrowicz On 7 April 2022, the Parliament passed the Act of 7 April 2022 on Medical Devices (the "Act"). It was signed by the President on 20...
20 Apr 2022 Advising the advisor - Tips for navigating the life sciences and regulatory environment: At the Intersection of Science and Law Podcast Series By Emilio Ragosa In this episode, DLA Piper managing partner Emilio Ragosa is joined by Kevin Sheridan, Joint Global Head of Healthcare Investment Banking...
19 Apr 2022 Access by Spanish patients to authorised medicines in Europe By Andrea Fernandez, Paula Gonzalez de Castejón Llano-Ponte The annual report "Indicators of Access to Innovative Therapies in Europe (W.A.I.T. Indicator)", prepared by the consultancy firm Iqvia...
08 Apr 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...
06 Apr 2022 New rules on the cultivation of medicinal cannabis in Poland By Amelia Prawda, Jolanta Dabrowicz On 29 March 2022, the Polish President signed the Act of 24 March 2022 amending the Act on Counteracting Drug Addiction (the "Act"). The...
05 Apr 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...
04 Apr 2022 MHRA announce new scheme for monitoring good manufacturing and distributions practices in IAG cases By Taryn Jones, Teresa Hitchcock The Medicines & Healthcare products Regulatory Agency (MHRA) has announced a new supervisory scheme as part of its process for monitoring...
30 Mar 2022 The moral imperative: Balancing innovation, regulation and prescription drug availability By Jim Greenwood, Geoffrey Levitt We stand today on the threshold of almost unimaginable progress in defeating diseases that have ravaged humans for millennia. New...
29 Mar 2022 The importance behind the recent scientific advances in reversing ageing in human egg cells By Bruna Rocha, Juliana Marcondes, Victoria Cristofaro Along with the article about the ascension of FemTechs in the healthcare market, produced by the Life Sciences, Healthcare and Cannabis...
28 Mar 2022 Patent term extensions in Australia – further challenges for pharmaceutical patentees By Nicholas Tyacke, Alexandra de Zwart, Sarah McKenzie Patent term extensions (PTEs) in Australia have been a hot topic over the past year. On Friday, things got a lot hotter for patentees...
25 Mar 2022 The new regulatory scheme for Software as a Medical Device approved by Anvisa (Brazil) By Bruna Rocha, Juliana Marcondes, Victoria Cristofaro This Wednesday (March 23, 2022), the Brazilian Health Regulatory Agency (ANVISA) approved a Collegiate Board Resolution (RDC) which...