20 Sep, 2023 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...
19 May, 2023 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...
16 May, 2023 The future of the assisted reproductive technology (ART): Modernising ART processes with AI By Nicholas Tyacke Greg Bodulovic Alexandra de Zwart Abi Ketheeswaran +1 more... Show less Assisted fertilisation processes involve striking the perfect balance between a range of complex factors – all of which play a critical...
20 Apr, 2023 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...
17 Mar, 2023 FDA calls for comments on artificial intelligence in drug manufacturing By Keo Shaw Bethany Hills Daniel Tobey Geoffrey Levitt +1 more... Show less On March 1, 2023, FDA’s Center for Drug Evaluation and Research (CDER) published a discussion paper on artificial intelligence (AI) in...
19 Jan, 2023 What is the projected – and much anticipated – key pillar for the health sector in Brazil in 2023? By Bruna Rocha Juliana Marcondes Victoria Cristofaro During the World Economic Forum 2023 in Davos, specialists discussing the topic of health unanimously indicated that “the past three...
28 Jun, 2022 Sweden to implement a new Biobanks Act By Fredrika Allard The Swedish government has decided to implement a new Biobanks Act, which is suggested to enter into force on 1 July 2023. The current...
27 Jun, 2022 FDA Warning Letter focuses on GMP failures at 503B compounding outsourcing facility By Bethany Hills Hilary Hoffman After a brief hiatus from the string of Warning Letters sent to 503B outsourcing facilities in mid- to late 2021, on June 7, 2022, FDA...
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...
16 Mar, 2022 UK ABPI calls for standardised international approach to university-industry collaborations By Richard Taylor Anna Wrench The Association of the British Pharmaceutical Industry (ABPI, the UK’s leading association for pharmaceutical companies), has published a...
14 Mar, 2022 Breaking taboos: the ascension of FemTechs in the healthcare market By Bruna Rocha Victoria Cristofaro International Women's Day, celebrated every March 8, focuses on the achievements of women over the years in the cultural, political and...
18 Feb, 2022 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...
08 Feb, 2022 An analysis of the effect of drug pricing provisions in the Build Back Better Act on pharmaceutical innovation By Kirsten Axelsen Having previously examined the impact of implementing international reference pricing in the United States, Charles River Associates (a...
26 Jan, 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...
17 Nov, 2021 Assessing the value of medicine for diverse patients: Implications of a QALY approach for health disparities By Kirsten Axelsen Momentum and debate about the application of cost-effectiveness analysis to determine the value and prices of prescription drugs in the...
25 Feb, 2021 Interim EDPB guidance on the application of GDPR to health research By James Clark In response to a set of questions from the European Commission, the European Data Protection Board (“EDPB”) has published some high level...