Pharma: Launch of Shortages Monitoring Platform, several Changes re Clinical Trial Management in EU Countries; Devices: Resolution on the need to revise the MDR and IVDR published; Compliance: CSRD still not implemented in...more
On January 17th, 2024, Belgium welcomed the official launch of the Belgian Health Data Agency. This Agency aims to enhance the availability and utilisation of health data and healthcare data with the objective to drive...more
Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more
We are excited to bring you the latest issue of our International Products Law Review with insights and updates on all aspects of products law. In this issue, we explore the trustworthiness of AI, a consumer whistleblowing...more
11/1/2019
/ Appeals ,
Artificial Intelligence ,
Class Action ,
Court of Justice of the European Union (CJEU) ,
Cybersecurity ,
EU ,
Evidentiary Standards ,
Global Market ,
Medical Devices ,
Punitive Damages ,
Regulatory Agenda ,
Restaurant Industry ,
Retail Market ,
UK ,
Whistleblowers
On 1 October 2019 the International Medical Device Regulators Forum (IMDRF) Medical Device Cybersecurity Working Group released a draft document titled "Principles and Practices for Medical Device Cybersecurity" (IMDRF...more
10/10/2019
/ Cybersecurity ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
International Medical Device Regulators Forum (IMDRF) ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Network Security ,
Pharmaceutical Industry ,
Popular ,
Regulatory Oversight ,
Vulnerability Assessments