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 […]
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 […]
Read moreIperion in the media: 2021 in review
Published on2021 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 […]
Read moreIperion welcomes Amy Williams to the team
Published onWe 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 […]
Read moreISO IDMP EU Implementation Guide v2.1 – what’s new?
Published onAs of Wednesday 30th June, an updated release of the EU’s IDMP Implementation guide v2.1 is now available from the European Medicines Agency (EMA) – the next step towards the implementation of ISO IDMP in Europe and initially for the Centralized Procedure. Although v2.0, published in February, was a solid, stable release – giving software […]
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