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 […]
UK’s medicines and medical devices regulator to tackle Brexit, technological advancements and regulatory challenges (including from COVID-19) in 2020 and 2021
The MHRA has established five strategic goals for 2020-21 that will impact all those operating in the UK medicines and medical devices industries
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
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.
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 […]
UK-specific guidance for the application and management of clinical trials in the context of COVID-19
The UK’s MHRA has stated it will be particularly flexible and pragmatic in authorising clinical trials connected to COVID-19, referring to its previous track record of having acted swiftly in past public health crises
Cooley’s international products law team is pleased to announce the third event in its webcast series looking at the latest consumer rights issues product manufacturers, suppliers and other stakeholders are facing in the rapidly changing global environment. This time we will be joined by Wendy Hederman, a partner at leading Irish law […]
2020 Vision – Looking Beyond COVID-19: Longer-Term Considerations for Supply and Manufacture of Products During COVID-19
With COVID-19 causing a pivot or volume increase in production, companies should pause to reflect on the longer-term considerations in terms of international product safety, liability and insurance law issues.