As pharmaceutical companies become more confident and ambitious in their use of the cloud to host, run and source applications, more recently extending the model to regulated applications, important considerations arise – particularly around associated systems validation and data governance.
Dynamic digital labels: from local pilot to regional reality
The potential of truly digital, data-driven product labeling in life sciences is huge, allowing companies to tailor and update their information more readily, unencumbered by space restrictions or print/production line deadlines. But what will it take for today’s discrete, local pilot projects to evolve into something more permanent and transformational for patients and healthcare professionals?
Duplicated document & data creation must stop!
Although the value of developing more data-driven processes is now widely recognized, many life sciences organizations today still routinely create critical documents and product labeling from scratch. This involves capturing and applying the same information repeatedly, yet often in different formats and using inconsistent terminology.
IDMP SPOR: Argh! So much is changing – now what?
EMA’s latest shift in its IDMP implementation guidance has been well documented. At the coal face, it’s causing all kinds of confusion as pharma companies try to figure out what they should do now. At Amplexor BE THE EXPERT 2022, K2 Consulting’s Kelly Hnat will draw on her ‘insider’ knowledge as an active participant in the EMA SPOR Task Force and member of the EMA PMS Process Focus Group, to provide some welcome clarity.
Beyond RA: the increasingly strategic remit of regulatory data
At Amplexor BE THE EXPERT 2022 Steve Gens will unveil brand new research into what constitutes world-class and strong operational RIM performance, especially post pandemic, and explore how system and process developments are now giving way to organizational priorities such as data science investment, cross-discipline data governance, & strategic use of AI/automation tools.
Amplexor Life Sciences’ annual Be The Expert conference
Amplexor Life Sciences’ annual BE THE EXPERT conference brings together leading global subject matter experts to explore the latest trends in IDMP, RIM, Labelling and Quality. We are happy to unveil the agenda for the upcoming Be The Expert conference, a virtual...