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TRENDING TOPICS
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.
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.
The importance of Supplier Qualification
Find out how to produce quality products and services to best meet business and regulatory requirements.
The practicalities of a data-driven future for life sciences companies
Find out how life sciences manufacturers and marketing authorization holders can reduce the maintenance burden and mitigate the risk of registration delays.
Planting for the future: IDMP’s benefits will be felt for generations
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.
A practical plan for becoming truly data-driven in life sciences
Guest contributor Peter Brandstetter explains why a digital approach to content control is the way forward for life sciences companies.
Now that IDMP is real, is your RIM roadmap on the right track?
Becoming ‘IDMP ready’ is a marathon, not a sprint: the most important factor for compliance is being on the right path. So what’s your starting point?
RIM data analytics: the key to life sciences transformation
Life sciences companies may have regulatory information management systems, but are they being used to their full potential?
IDMP as the key to smarter regulatory submissions management
With EU IDMP 2.0, life sciences companies need to be on the lookout. Check how you can maximize efficiency of your regulatory submission processes.
7 use cases for VR exploration of regulated life sciences data
Virtual and augmented reality technology continue to develop and improve at a rapid pace. Here’s how it can be useful for life sciences.
Leveraging the new EU IDMP Target Operating Model
With the publication of EMA’s IDMP/SPOR implementation guide (V2), the transition of the ISO IDMP product data standard can be transformational.
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