{"id":49405,"date":"2024-03-10T08:03:10","date_gmt":"2024-03-10T08:03:10","guid":{"rendered":"https:\/\/www.arisglobal.com\/?p=49405"},"modified":"2024-09-05T08:20:48","modified_gmt":"2024-09-05T08:20:48","slug":"regulatory-process-transformation-including-closer-collaboration-with-safety-pv-starts-with-cloud-based-rim","status":"publish","type":"post","link":"https:\/\/www.arisglobal.com\/blogs\/regulatory-process-transformation-including-closer-collaboration-with-safety-pv-starts-with-cloud-based-rim\/","title":{"rendered":"Regulatory process transformation \u2013 including closer collaboration with Safety\/PV – starts with cloud-based RIM"},"content":{"rendered":"

At Breakthrough 2024 this month, Hans van Leeuwen, Head of RA Data and Systems Excellence at Astellas Pharma, will\u00a0deliver a keynote on the company\u2019s journey to the cloud for regulatory information management. As well as enabling data-driven Regulatory processes, the transition is part of a strategic move to make RA the original source for Safety and Pharmacovigilance product data \u2013 a subject Hans will go on to discuss in a panel debate.\u00a0<\/strong>
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In 2020, Astellas Pharma formally launched its cloud-based regulatory information management platform, based on the latest incarnation of LifeSphere. Moving to the cloud freed up more than 70 per cent of people\u2019s time which previously had been spent maintaining the systems housing information about registered products.\u00a0
\nToday, those individuals\u2019 talent is put to better use in proactive data stewardship, supporting the Regulatory function more directly, and more strategically, to enable reliable, efficient, and standardized data exchange – in line with the demands of EU IDMP and recommended industry best practice.<\/span>\u00a0<\/span><\/p>\n

From cloud-based RIM to more seamless Safety\/Regulatory processes<\/span><\/b>\u00a0<\/span><\/p>\n

Astellas Pharma\u2019s next goal is to make Regulatory Affairs and its cloud-based RIM platform the definitive source not only for Regulatory data and processes, but also the origin for product information referenced by the company\u2019s Safety\/Pharmacovigilance operations.<\/span>\u00a0<\/span><\/p>\n

Instead of maintaining a separate Safety\/PV product database, with the potential for information discrepancies between functions, from August\/September this year, the LifeSphere-based Regulatory data repository will serve a more integrated and interoperable Regulatory and Safety\/PV capability, with more seamlessly connected processes.<\/span>\u00a0<\/span><\/p>\n

As well as enabling accelerated and more efficient workload execution, the ultimate benefit will be to patients who will gain earlier access to the latest safety information.<\/span>\u00a0<\/span><\/p>\n

I\u2019ll be discussing the highlights and challenges of our Regulatory transition to the cloud in my keynote on Day 1, and will pick up the theme of Regulatory and Safety\/PV interoperability in a later panel debate, in discussion with the Head of Pharmacovigilance Audit & Inspection Management at Merck, as well as ArisGlobal\u2019s subject matter expert.<\/span>\u00a0<\/span><\/p>\n

I look forward to seeing you there.<\/span>\u00a0<\/span><\/p>\n