Is your medical device cybersecure enough?

Manufacturers of digital medical devices, medical devices that incorporate electronic programmable systems (PEMS) and software that are medical devices in itself, will have full responsibility to establish and maintain ‘security by design’ with the introduction of the Medical Device Regulation (MDR).  A secure product development life cycle based on state-of-the-art practices and modern tool chains […]

CTIS Webinar responses: Ready or not Deloitte-Iperion held a webinar on 20 September 2021, exploring some of the challenges Industry will face when preparing for and operating under the new Clinical Trial Regulation (CTR) and Clinical Trial Information System (CTIS). During the webinar we surveyed the audience to understand where representatives from Industry felt they […]

The European Commission hopes to create a favorable environment to conduct clinical trials in the EU with the implementation of the Clinical Trial Regulation (CTR), which is expected to go live 31 January 2022. In this article we provide an overview of the key considerations with regards to application procedures and timelines regarding the submissions […]

The year 2022 has just began. We have entered it with optimism and hope. Whatever the year brings, we will be ready to empower the life sciences industry and regulators to innovate, improve business processes and optimize regulatory information management in the broadest sense for better patient outcomes. We will work hard, forge new partnerships […]

The European Commission hopes to create a favorable environment to conduct clinical trials in the EU with the implementation of the Clinical Trial Regulation (CTR), which will be going live at 31 January 2022. In the weeks before we will publish articles to help you prepare. In this article we provide an overview of the […]

The European Commission hopes to create a favorable environment to conduct clinical trials in the EU with the implementation of the Clinical Trial Regulation (CTR), which will be going live at 31 January 2022. In the weeks before we will publish articles to help you prepare. In this article we provide an overview of the […]

2021 saw Iperion continue to expand its global media reach. Some of the key articles published in 2021 are here:   New European medicinal data standards – getting ready for change In January 2021, The European Medicines Agency (EMA) published a guide to implementing IDMP data standards forecast to be ”a game changer” for the […]

We are very pleased to welcome Amy Williams to our team. She will assume the position of Director within Iperion – a Deloitte business, from December 6th. Amy brings 15 years of experience in life sciences, working in Regulatory Affairs – both within the industry and as a software/service provider (Merck Serono, Parexel/Calyx). Amy is […]