May 26, 2023 EU Pharma Law Revision: First Reactions and Next Steps By Marco de Morpurgo Laetitia Mouton Mary Foord-Weston Exactly one month ago, on 26 April 2023, the European Commission (EC) adopted its long-awaited proposal for the revision of the EU...
May 19, 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...
Apr 28, 2023 The UK voluntary scheme for branded medicines pricing and access (VPAS): just what the doctor ordered, or a bitter pill to swallow? By Michael Stead Martha Pownall On the 1 April this year, amidst storm clouds gathering above the NHS in the form of staffing strikes, record waiting times and chronic...
Apr 20, 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...
Apr 17, 2023 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...
Apr 17, 2023 Inspirational Women in Life Sciences: Rebecca Lacey and Sonya Roy By Alexandra de Zwart In the third edition of our Cortex series on Inspirational Women in Life Sciences, we are delighted to feature two incredible Australian...
Apr 17, 2023 Plausibility of inventions: the decision of the EPO Enlarged Board of Appeal in G 2/21 By Massimiliano Tiberio Introduction On March 23rd, 2023, the Enlarged Board of Appeal of the EPO issued the long-awaited decision concerning the concept of...
Apr 04, 2023 You say “ed”, they say “ad”: The fine line between lawful educational campaigns and unlawful advertising of therapeutic goods in Australia By Nicholas Tyacke Greg Bodulovic Alexandra de Zwart Companies operating in the life sciences industry play a vital role in raising awareness of diseases and other medical conditions,...
Mar 17, 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...
Mar 14, 2023 Advertising therapeutic goods in Australia (don't let your ad make you sad) By Nicholas Tyacke Greg Bodulovic Alexandra de Zwart Due to a complex array of legislation, regulations and codes, advertising therapeutic goods in compliance with Australian law can be a...
Mar 10, 2023 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...
Feb 06, 2023 Poland - Life Sciences Monthly Brief, January 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: Pharmacies; Clinical...
Feb 01, 2023 Working on the affordability of medicines: 2023 begins with an important message on excessive pricing - Portugal By Mariana Ricardo Early this year, the Portuguese Minister of Health stated the public expense with medicines in 2022 showed an increase of more than EUR...
Jan 23, 2023 Pharmaceutical and medical sector in Poland, DLA Piper Report By Andrzej Balicki, Ph.D. Jolanta Dabrowicz We would like to invite you to read our report summarising the second edition of the DLA Piper survey "Pharmaceutical and medical sector...
Jan 19, 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...
Dec 19, 2022 FDA Denies Requests for Revocation of EUA for Covid Vaccine for Use in Individuals 5-11 and 12-17 Years of Age By Melissa Gilmore Jarred Reiling Keo Shaw The FDA has denied two citizen petitions filed on behalf of the Informed Consent Action Network (ICAN) requesting the agency revoke its...