Prerequisites for Structured Content Management (SCM)
SCM tools are on the market for many years. How come pharmaceutical industry has not adopted this technology? Why do regulatory dossiers primarily consist of PDF documents? What do Health Authorities do with these PDF files and why are they requesting more structured data (e.g. eApplication Forms and CESSP) in accordance with standardized terminology (e.g. SPOR and PQ/CMC)? How does industry manage their data? Is this an efficient process?
Sure, the majority of you already know the answers, but how do we cope with this? This webinar will report on a proof of concept and subsequent prerequisites to inherit data from the master data database to documents and dossiers and back.
Hans van Bruggen, Director of and Senior Regulatory Affairs Scientist at Qdossier and eCTDconsultancy