Category: Our current thinking
Time to consider and act: A newly extended “Regulatory Grace Period”
ISO IDMP is coming – proposed now as an EMA phased approach – but we are not there yet, with EC to approve: Worth reading!
Time to share Reflections:
With all these standards the question comes up:
How does a company want to apply them? What is it’s business ambition?
Though many points remain open, we have at least some indications about how the European Agency intends to proceed:
Business Intelligence (BI) and Analytics for Healthcare (HC), considering the impact of Social Media:
Source for BioPharma R&D & Business Development
The application of ISO IDMP Standards will bring you to an important level of Regulated, Actionable Quality Information for you internally and with your key Stakeholders – globally
Since the Vioxx scandal and the product recall in 2004 the urgent need for patient safety reached the highest levels of awareness and the requirement to harmonize data globally to take effective and timely actions.