ONLINE EVENT ON DEMANDBe The Expert 2022 Day 2 PresentationsAmplexor Life Science's conference Be The Expert brings together leading subject matter experts...
ONLINE EVENT ON DEMANDBe The Expert 2022 Day 1 Presentations Amplexor Life Science's conference Be The Expert brings together leading subject matter...
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.
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?
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.
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.
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.
The big DADI switch: EMA’s 11th-hour IDMP rethink and what it means for data-based regulatory submissions
Learn more about the latest EMA’s IDMP rethink and how that will affect data-based regulatory submissions.
Find out how to produce quality products and services to best meet business and regulatory requirements.
Find out how life sciences manufacturers and marketing authorization holders can reduce the maintenance burden and mitigate the risk of registration delays.
Data-driven, IDMP-based regulated product data and submissions management is a long journey, and companies won’t reap the benefits of their preparation efforts for some time yet.
Guest contributor Peter Brandstetter explains why a digital approach to content control is the way forward for life sciences companies.
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