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 […]
Read morePersonal blog | My first IDMP implementation projects
Published onThis is a personal blog from Marijke Blaauwhof, Healthcare and Life Sciences Consultant at Deloitte. “For the last 5 years, I have been interested in the life-sciences industry with a strong focus on supporting large transformations within the pharmaceutical organizations through-out the value chain. Having worked in the pharmaceutical industry prior to joining Deloitte, I […]
Read morePersonal blog | With time comes a certain perspective
Published onThis is a personal note from Camiel Hoogendoorn, one of our senior consultants “It was a cold but sunny day in November in 2015 when I got the email that I was hired by Iperion Life Sciences Consultancy. I was eager to start working at this small company with great ambitions. At that time Iperion […]
Read morePersonal blog | A shared vision to make a change
Published onThis is a personal note from Amy Williams, the newest Director of Team Iperion. “Three months in and last week provided the first opportunity to meet colleagues face-to-face. Starting a new role in the midst of a pandemic provides a nuance to onboarding previously unanticipated. This made the meeting face-to-face all the sweeter. The pleasure […]
Read moreCTR | Application procedures and Timelines under CTR
Published onThe 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 […]
Read moreOptimism and hope – 2022 has started
Published onThe 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 […]
Read moreCTR | User management in CTIS
Published onThe 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 […]
Read moreCTR | Legal representation set out in the EU Clinical Trial Regulation
Published onThe 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 […]
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