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 […]
UK-specific guidance for the application and management of clinical trials in the context of COVID-19
Sarah-Jane Dobson and Amal Ali
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
WEBCAST: Products & Consumer Rights: Global Hot Topics
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
Sarah-Jane Dobson, Andrew Barr and Richard Hopley
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.
WEBCAST: 2020 Vision – Looking Beyond COVID-19. Longer-Term Considerations for Supply and Manufacture of Products During COVID-19
Many companies are opting to rapidly pivot into new product lines or significantly increase their production volumes. In doing this, they are relying on exceptions to, and derogations from, the usual regulatory regimes, or a flexible approach to enforcement by regulatory authorities – all motivated by the unique context of COVID-19. […]
The EU delays application of its new medical devices regime
Sarah-Jane Dobson and Ross Lennox
The EU has decided to postpone application of its new medical regime by one year. Although COVID-19 is cited as the reason, the delay is no doubt welcomed by an industry that has lobbied for postponement of the regime for some time because of perceived issues with its implementation.