Category: Regulation & compliance
EU adjusted 2020 Work Programme: product safety and consumer rights remain on the agenda
The European Commission published its adjusted Work Programme for 2020, following the impact of the COVID-19 pandemic. Product safety and consumer law initiatives remain very much on the Commission’s agenda. However, some timelines have been extended and stakeholders will be given additional time to contribute to consultations to help shape future policy and law in these areas.
WEBCAST: EU and AI – Navigating the European Approach
Cooley’s international products law team are pleased to announce the fourth event in its webinar series. This webinar will look at the European Union’s approach to Artificial Intelligence including the impact of the European Commission’s White Paper on Artificial Intelligence. The team will be joined by members of Cooley’s Technology […]
COVID-19: Weekly Life Sciences Digest – Testing Kits for COVID-19
Natasha Leskovsek, Andrew Barr, Sarah-Jane Dobson, Edward Turtle, Harriet Jones and Julia Maskell
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.
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
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.
COVID-19: Weekly Life Sciences Digest – PPE in EU and UK
Sarah-Jane Dobson, Edward Turtle, Harriet Jones and Julia Maskell
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.
FSA raises bar for CBD food products
Jamie Humphreys and Emma Lidstrom
UK food safety watchdog issues warning to CBD businesses that their products could be ‘taken off the shelves’ if the industry fails to submit valid novel food authorisation applications by 31 March 2021.
COVID-19: Weekly Life Sciences Digest – Initiatives for Fast Tracking Treatments and New FDA Guidance
Phil Mitchell, Edward Turtle, Sana Shakir, Julia Maskell 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.
COVID-19: Weekly Life Sciences Digest – International Collaboration and New Guidance in the EU and UK
Sarah-Jane Dobson, Edward Turtle and Julia Maskell
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.
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. […]