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Global Pharmaceutical Regulatory Affairs Summit
22-24 October 2024
Sheraton Brussels Airport, BrusselsHybrid Event

Filip Cvetanovski
Regulatory Affairs at ALKALOID AD Skopje
Speaker

Profile

Filip Cvetanovski is a Regulatory Operations Officer within the Regulatory Affairs department inside 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 roles before becoming a part of the Regulatory operations unit were submission planning, management of product lifecycle, and project coordination within the processes for registering a new product.

His experience within the role he occupies at the moment consists of data management for the company product portfolio, electronic publishing and submission of documentation, general technical support for the daily operations within the documents management solution in the department and implementation of the company system for management of regulatory intelligence as well as general management of XEVMPD, IDMP and FMD data.

Filip is also responsible for 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

Agenda Sessions

  • Aligning Teams: Effectively Integrating Regulatory Operations within Regulatory Affairs

    09:40