Filip Cvetanovski

Regulatory Affairs at ALKALOID AD Skopje

Speaker

Filip Cvetanovski is a Master Data Steward for RIM systems in ALKALOID AD Skopje, one of the biggest pharmaceuticals’ manufacturer and overall industry in Southeast Europe.

He started his career in the pharmaceutical industry in 2016. Before joining the Regulatory operations team, he also worked in several units within the Regulatory Affairs department, the submission management unit responsible for the EU region and the unit responsible for new product registration.

His experience within the role he occupies at the moment consists of data management for the company product portfolio, data governance as well as general management of XEVMPD, IDMP and FMD data.

Filip has also experience in the implementation and maintenance of a global Regulatory Information Management system within the company.

He has also several publications, most notably the following:

• Counterfeiting of medicines as an infringement of the intellectual property rights (http://bulletin.mfd.org.mk/volumes/Volume 62/62_008.pdf)
• Regulatory Аffairs in the pharmaceutical industry – insights (http://bulletin.mfd.org.mk/volumes/Volume 66_2/66_2_005.pdf)
• Good Distribution Practice in preserving the integrity and safety of the supply chain of pharmaceuticals (http://bulletin.mfd.org.mk/volumes/Volume 66_3/66_3_096.pdf)

Filip holds a specialist degree in pharmaco-economics and health management at the Faculty of Pharmacy within the “Ss. Cyril and Methodius” University in Skopje.