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Posts related to ‘regulation’

April 08, 2022
Mark Buckingham
recall advisor
European Commission to focus on textile industry sustainability in 2022

For years, the European Commission has been working on a plan to create a circular economy for a more sustainable future. The resulting Circular Economy Action Plan (CEAP), adopted in March 2020, includes several strategic initiatives that would tran…

April 08, 2022 by Mark Buckingham, recall advisor
March 11, 2022
Julie Ross, International business development director and Luke Evans, business development manager
European recalls rose in 2021 despite COVID-19 disruptions

As we enter the third calendar year of the COVID-19 pandemic, regulators are adapting to the “new normal.” As reported in our latest edition of the recall index report, product recalls rose by over a quarter (25.5%) across key European industries in …

March 11, 2022 by Julie Ross, International business development director and Luke Evans, business development manager
February 16, 2022
Mark Buckingham
recall advisor
New EU Clinical Trial Regulation brings positive and negative changes

The European Union Clinical Trial Regulation (CTR) recently came into force and introduced a unified regulatory regime that applies to all EU member states. While the goal of the CTR is to reestablish the EU’s competitiveness in the field of scientif…

February 16, 2022 by Mark Buckingham, recall advisor
February 11, 2022
Matt Walker
recall advisor
FDA focuses on women’s health in medical device research and regulation

The US Food and Drug Administration (FDA) has turned its attention to the development and regulation of medical devices unique to women’s health. The FDA’s Center for Devices and Radiological Health (CDRH) recently finalized its Health of Women…

February 11, 2022 by Matt Walker, recall advisor
January 17, 2022
Max Koonce, Chief claims officer and Bryon Bass, SVP workforce absence
Vaccine mandate ruling points employers back to state and local guidance

On January 13, 2022, the Supreme Court blocked the Biden Administration from implementing and enforcing a vaccine mandate on large businesses (defined as those with 100 or more employees). The Occupational Safety and Health Administration (OSHA), w…

January 17, 2022 by Max Koonce, Chief claims officer and Bryon Bass, SVP workforce absence
January 13, 2022
James Norman
International business development director
Corporate governance and claims management in Africa

African insurers are constantly evolving best practices to ensure they further adopt international insurance principles, stay compliant with changing regulations and leverage opportunities to grow — whether that be through International Finance…

January 13, 2022 by James Norman, International business development director
January 10, 2022
Mark Buckingham
recall advisor
Are there sparks ahead for electrical OEMs?

As electrical OEMs congratulate themselves on a bumper year for sales, many remain cautious about what 2022 holds in store as new right to repair regulations start to bite. In some respects, 2021 has been a good year for electrical appliance manufa…

January 10, 2022 by Mark Buckingham, recall advisor
December 13, 2021
Guest authors: Sean Wood and Katherine Goodyear
Spotlight: When a cyberattack strikes: Protecting and repairing brand reputation

Foreword by Chris Harvey, SVP client services at Sedgwick: Welcome to the latest edition of spotlight. Spotlight is our way of sharing insights and perspectives from our strategic partners – lawyers, insurers, risk managers and crisis communicatio…

December 13, 2021 by Guest authors: Sean Wood and Katherine Goodyear
September 28, 2021
Matt Walker
FDA regulations for AI/ML-based medical devices expected soon on heels of EU MDR

Following the lead of the European Union and Great Britain, the U.S. FDA has begun rolling out its action plan for regulating artificial intelligence/machine learning (AI/ML)-based software as a medical device. The United Kingdom’s Medicines and He…

September 28, 2021 by Matt Walker
September 16, 2021
Eur Ing Mark Hawksworth
Global technology specialist practice group leader and executive MCL adjuster
Claim farming for damages in light of data protection laws

As new data protection laws are introduced, so are new challenges. Claim farming occurs when parties submit claims for financial gain against targets unaware of data misuse and is on the rise in the UK. After navigating hardship related to COVID-19 a…

September 16, 2021 by Eur Ing Mark Hawksworth, Global technology specialist practice group leader and executive MCL adjuster
July 19, 2021
Chris Harvey
VP, crisis solution
CBD and cannabis: With opportunity comes risk

An exclusive life sciences webinar hosted recently by Sedgwick’s brand protection experts offered insight into the latest product safety challenges facing medical device, pharmaceutical and life sciences companies, including an insightful discussion …

July 19, 2021 by Chris Harvey, VP, crisis solution
July 13, 2021
Mark Buckingham
recall advisor
Beware of all that glitters – it could be cadmium

Thanks to the ubiquity of ecommerce, consumers can now buy low-cost jewellery from anywhere in the world, but this is raising serious questions about the integrity and safety of the products, particularly the presence of potentially dangerous heavy m…

July 13, 2021 by Mark Buckingham, recall advisor
June 18, 2021
Luke Evans
Green light for self-drive in UK raises risk concerns in motor supply chain

The UK is the first country in the world to announce regulated guidelines for self-driving cars on motorways. This means you could see cars with Automated Lane Keeping Systems (ALKS) on British roads by the end of 2021. Many cars already incorporate…

June 18, 2021 by Luke Evans
June 04, 2021
Mark Buckingham
The hidden danger in common crops

You can’t see, taste or smell them but aflatoxins can be present in everyday dried staples. And with COVID-19 and global warming impacting crop production and storage, they are on the rise. During the month of April 2021, there were 22 RASFF (Rapid…

June 04, 2021 by Mark Buckingham
June 02, 2021
Matt Walker
recall advisor
DOJ increasing enforcement on off-label promotion: Here’s what to expect

We’ve been warned. Recent settlements between the U.S. Department of Justice (DOJ) and several FDA-regulated drug and medical device manufacturers serve as a prelude to future DOJ enforcement activity involving off-label promotion. The DOJ and the U…

June 02, 2021 by Matt Walker, recall advisor
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