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Tag / it life sciences

PSMF establishment and maintenance, business as usual?

News   •   May 31, 2013 09:00 CEST

Since the implementation of Directive 2010/84 and Regulation 1235/2010, marketing authorisation holders (MAHs) with products on the European market are obliged to maintain, and make available upon request, a Pharmacovigilance System Master File (PSMF).

BI tool for smooth submission planning and execution

News   •   Apr 12, 2013 09:00 CEST

Regulatory approval for pharmaceutical products can be difficult to obtain, not least because the submission process is often slow and prone to errors. Thomas Svendsen and Peter Noes of NNIT tell World Pharmaceutical Frontiers how regulatory teams can use a business intelligence tool to monitor submission status and hasten time to market.

Make the most of serialization

News   •   Apr 12, 2013 09:00 CEST

Change is afoot for pharmaceutical companies, with new serialisation legislation on the agenda. To help stem the problem of drug counterfeiting, they will be required to adopt a unique serial number labelling system and adapt their business processes accordingly. How can companies derive real business value from the investments they are now required to make?