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Back on track – what’s next for ISO IDMP?
Amplexor's Siniša Belina, Senior Life Sciences Consultant, was featured in Pharmafield, a UK magazine focused on the pharmaceutical sector. The European Medicines Agency is implementing the IMDP standards developed by ISO, which were created for the identification and description of medicinal products for human use. In Back on track – what’s next for ISO IDMP?, Siniša offers tips on the implementation of this regulatory standard by life sciences firms, who now have a period of one year to implement it.
About the author
Siniša Belina is a Senior Life Sciences Consultant within Product Management team. He applies his detailed knowledge of pharmaceutical processes and documentation to the areas of business process analysis, optimization of software solutions and demonstration of their capabilities. He started his professional career at Pliva (now the TEVA Group), where in addition to his responsibilities in manufacturing, he engaged in a successful EDMS implementation project. He later joined KRKA’s Regulatory Affairs Department, and finally moved to Amplexor in 2008. Siniša received his Bachelor of Science degree in Pharmacy from Zagreb University.