Tag: US
EU and AI – Navigating the European Approach
Get access to Cooley’s webinar on the European Commission’s White Paper on Artificial Intelligence
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.
Products & Consumer Rights: Global Hot Topics
Edward Turtle and Carol Holley
Key takeaways from the Cooley products team webinar on consumer rights.
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
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.
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.
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.
2020 ICPHSO Annual Meeting and Training Symposium: key highlights
Jamie Humphreys and Carol Holley
Product safety professionals from around the globe attended the ICPHSO Anunal Symposium in Orlando. We are pleased to bring you some of the highlights coming out of the many interesting sessions.
UK-specific guidance for manufacture and supply of certain medical devices for COVID-19
As noted in our previous overview article, it is vital that interested companies continue to monitor and strategically act on the rapidly changing government position on the regulation of specific medical supply product types in the context of COVID-19.