The New Blue: EU Updates Key “Blue Guide” to Products Laws
Edward Turtle and Tracey Bischofberger
The hotly-anticipated revision of the European Commission’s Blue Guide has been published. Here’s our take on why this matters to anyone involved in the manufacture, import or sale of products in the EU.
WEBCAST: Liability in Times of Change for the Life Sciences Industry
The growth of digital health technologies and artificial intelligence raises novel risks, including data protection and cybersecurity risks, and key questions about the liability of services and software as a product remain unanswered. Wearables are blurring the line between consumer technology and medical devices, and consumer health data has the […]
WEBCAST: Regulating Online Platforms
The online sale of products is under increasing regulatory scrutiny, and the EU’s recently announced draft Digital Services Package promises to alter how online platforms and those who sell through them do business. Join Cooley’s international products law team for the next event in its webinar series, which will feature […]
WEBCAST: The Final (Brexit) Countdown
Preparing your business for international trade and product safety & compliance legislation changes come January 1. The reality of the most significant shake-up of UK trade in living memory is fast approaching. Come January 1, 2021, businesses manufacturing, importing and distributing products in the UK will be subject to a […]
UK’s medicines and medical devices regulator to tackle Brexit, technological advancements and regulatory challenges (including from COVID-19) in 2020 and 2021
Sarah-Jane Dobson and Amal Ali
The MHRA has established five strategic goals for 2020-21 that will impact all those operating in the UK medicines and medical devices industries
The Science of Regulation and the Regulation of Science
Sarah-Jane Dobson and Sumiyya Abdur-Rahman
The EU’s Five-Year Strategy for Modern Human Medicines
WEBCAST: Moving to a Circular Economy
Cooley’s international products law team are pleased to announce the fifth event in its webinar series, together with experts from Compliance & Risks and Ramboll. As an area of major regulatory and business change for product manufacturers, suppliers and other stakeholders, we anticipate the impact of the move towards the […]
COVID-19: Weekly Life Sciences Digest – International Collaboration and Adjusted Exports/Import Rules
Sarah-Jane Dobson, Edward Turtle and Alicia Johnson-Cole
With COVID-19 heralding unprecedented changes in the sector, our life sciences products experts provide a weekly summary of key international developments to keep you up to date.
Flexibility for our furry friends
Sarah-Jane Dobson and Olivia Flasch
EU regulators have taken steps to address supply chain disruption and increased demand in veterinary medicines caused by the COVID-19 pandemic.
Insurance: Not Much of a Muchness
Many policyholders believe that the insurance available on the market covering a particular type of risk is much of a muchness. The disputes about insurance cover for business interruption losses due to COVID-19 have highlighted that this assumption is misconceived. Insurance policies are not commoditised. There are no standard forms […]