Category: Regulation & compliance
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. […]
The right to be recognised, rebooted: Regulation (EU) 2019/515 on the mutual recognition of goods starts to apply
Claire Temple, Edward Turtle and Olivia Flasch
The EU’s new regulation on the mutual recognition of goods has started to apply. One part of the so-called “Goods Package”, it aims to improve the application of the mutual recognition principle for goods and remove unjustified barriers to trade within the EU.
COVID-19: Weekly Life Sciences Digest – Guidance for Industry in EU, UK and US
Natasha Leskovsek, 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.
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.
RED Talk: EU consulting on proposed laws to deal with software that alters the safety or compliance of connected devices
Tracey Bischofberger and Alicia Johnson-Cole
The European Commission is holding a targeted consultation on proposed new laws to deal with software that alters the safety or compliance of connected devices. The consultation closes on 22 May 2020.
Green is for go: European Commission presents its action plan for the single market
Edward Turtle and Carol Holley
The action plan sets out proposals for better implementation and enforcement of single market rules.
Unprecedented and under pressure? How international product regulators are responding to COVID-19
Claire Temple, Rod Freeman, Matt Howsare and Olivia Flasch
In such unprecedented times, international product regulators are finding themselves under increasing pressure and seem to be reacting with a previously unseen level of agility and flexibility. We look at what is happening, globally. Is it business as usual? What are we seeing them focus on? And what does this mean for the future of products regulations?
COVID-19 – Cooley’s multi-disciplinary response team and resources
Our dedicated multi-disciplinary team are on hand to get you through the COVID-19 crisis