Blog: Regulatory process transformation – including closer collaboration with Safety/PV - starts with cloud-based RIM

At Breakthrough 2024 this month, Hans van Leeuwen, Head of RA Data and Systems Excellence at Astellas Pharma, will deliver a keynote on the company’s 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 – a subject Hans will go on to discuss in a panel debate. 

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’s time which previously had been spent maintaining the systems housing information about registered products.  

Today, those individuals’ 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. 

From cloud-based RIM to more seamless Safety/Regulatory processes 

Astellas Pharma’s 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’s Safety/Pharmacovigilance operations. 

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. 

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. 

I’ll 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’s subject matter expert. 

I look forward to seeing you there. 

• Hans van Leeuwen has been Head of Regulatory Operations for Europe at Astellas Pharma for more than 12 years. He is based in Leiden, the Netherlands. 
• At Breakthrough 2024, on Day 1 – Tuesday March 20 – Hans will present a customer keynote on the company’s transformative journey to the cloud, with ArisGlobal LifeSphere: Astellas – A Transformative Journey to the Cloud 
• On Day 2, Wednesday March 21 – Hans will take part in a panel discussion exploring the potential for cross-function process transformation and automation, supported by greater integration of Safety & Regulatory information: Interoperability – the value of combining Safety & Regulatory