Category: COVID-19

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. […]

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.

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

Rod Freeman and Fergal Duggan

Our dedicated multi-disciplinary team are on hand to get you through the COVID-19 crisis

The ever-changing COVID-19 regulatory landscape: The European Commission issues guidance on the manufacture of certain medical supply products for COVID-19

Sarah-Jane Dobson and Olivia Flasch

The regulatory environment for rapid production of COVID-19 medical supplies changes on a daily basis. Most recently, the European Commission has weighed in to provide some Europe-wide insight. The guidance provided only serves to underline the significant pressures that all of those in these areas are having to grapple with, as well as the considerable complexity of applicable regulatory regimes.

WEBCAST: Extraordinary Times Call for Extraordinary Measures – The Response of Product Regulators Around the World to the COVID-19 Crisis

Cooley’s international products law team is pleased to announce the launch of a webcast series focused on the issues product manufacturers and suppliers are facing in the rapidly changing global environment. This series will deliver practical insights and the latest updates on critical matters for companies in the products sectors. […]