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?

The LSCP Life Sciences Consulting Partners Management Team is pleased to announce the adherence of a new Partner in the context of our extended global Enterprise Data Governance (EDG) Management and eHealth transformation initiative to our professional network for the Life Sciences Industry and Regulators. Jerry Quinn, PMP, BA Engineering

The LSCP Life Sciences Consulting Partners Management Team is pleased to announce the adherence of a new Partner in the context of our extended global Enterprise Data Governance (EDG) Management and eHealth transformation initiative to our professional network for the Life Sciences Industry and Regulators. Josef Leuchtner, Ph.D.

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.

The LSCP Life Sciences Consulting Partners Management Team is pleased to announce the adherence of a new Associated Partner in the context of our extended Enterprise Data Governance (EDG) Management and eHealth transformation initiative to our global professional network for the Life Sciences Industry and Regulators. Thomas Schuetz, MBA/MSc. IS

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.