27 Jul, 2023 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and modernized clinical trials By Bethany Hills Adam Donat The Food and Drug Administration (FDA) has released a draft guidance titled, “Good Clinical Practice (GCP) E6(R3),” explaining how the...
26 Jul, 2023 European Medicines Agency opens dialogue on use of AI in pharmaceutical life cycle By Danny Tobey Keo Shaw Marco de Morpurgo To open a dialogue with developers, academics, and regulators, the European Medicines Agency (EMA) recently published a draft Reflection...
17 Jul, 2023 Industry organizations establish practical frameworks for digital health and healthcare AI tools By Dan Kagan Keo Shaw Rachel Ludwig Kristi Kung Danny Tobey +2 more... Show less Digital health tools have proliferated in recent years, particularly during the exponential adoption of telehealth and remote care during...
13 Jul, 2023 Whistleblower Protection Directive: Impact on Employers in the Life Sciences Sector By Ciara McLoughlin Businesses in the Life Science sector have already seen that there can be major consequences where an employee blows the whistle on...
10 Jul, 2023 Poland - Life Sciences Monthly Brief, June 2023 By Andrzej Balicki, Ph.D. Jolanta Dabrowicz Przemysław Matuszewski Urszula Grębowska +1 more... Show less Download a copy of our June monthly briefing, which covers key updates and insights in the following areas: Medical devices; Clinical...
04 Jul, 2023 Updated telehealth guidelines to increase protection for patients By Greg Bodulovic Nicholas Tyacke Alex Horder Alexandra de Zwart Tudor Filaret Sharon Zhang +3 more... Show less The Medical Board of Australia (MBA) has issued updated guidelines for telehealth consultations between medical doctors and patients that...