Category: Our current thinking
We are reaching out to our customers and friends community to first and foremost wish you and Yours health and safety during this time. Nothing is more important and valuable than the health of you and your families and the communities you live in. The well-being of our Subject Matter Experts, customers, and partners is our first priority.
Creating a Holistic View on Actionable, Regulated Data Assets Have you ever explored content value of data assets that Regulatory Affairs governs in one way or another? Is the process of current data/information exchange “seamless” between Market Access >< Medical Information (Affairs) >< Regulatory Affairs >< Health Authorities <> Others?
LSCP “Format Free Initiative” (FFI) gets traction A solid EDG Data Strategy starts … We have to get organized in a different way. Valuable data is extracted from your Digitalization processes. New data sources are being merged with legacy data. The amalgamation of data needs to make good business sense as well as regulatory sense. Regulators like FDA & EMA have recently published their views about what and how they would consider data to be relevant.
Creating a Holistic View & Use of Enterprise Data We need to take a holistic view. We have noted that participants and collaboraters in Clinical Trials speak another professional language, different from the manufacturing floor and/or the Patients/Providers (RealWorld Data). Authors need to be understood by reviewers/approvers, users and recipients. Business data need to have value within and across all functions, usable/re-usable everywhere – globally.
How important are Product Information (PI) DATA Assets in your planning & day-to-day work? The following was published yesterday, in context of a up to 30 % HR and Knowledge Drain after a press conference by Prof. Guido Rasi, EMA CEO.