The importance of ensuring drug safety
We asked Jesper Borgstrøm, Advanced Advisory Consultant, NNIT Life Sciences – Regulatory Affairs, to take us through the safety aspects of one of the world’s most regulated product development and manufacturing processes.
ISO IDMP is the next after xEVMPD
ISO IDMP is the next wave in the pharmacovigilance legislation after xEVMPD. But with a global scope and requiring data integration from the entire company it is a much bigger wave. ISO IDMP will transform your regulatory IT strategy.
PSMF establishment and maintenance, business as usual?
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).