Alina Panourgia is a dedicated professional with a background in pharmacovigilance, regulatory affairs, quality improvements and auditing. Her career spans continents, contributing to the healthcare industry in Europe, Southeast Asia, LATAM, and the Middle East across various therapeutic areas.

Starting in Southeast Asia, Alina conducted audits, implemented quality improvements at manufacturing sites and ensured strict compliance with local and international standards by authoring the Chemistry, Manufacturing, and Controls (CMC) sections of dossiers for submissions in the US, EU and Southeast Asia.

Since relocating to the Middle East, Alina has worked as an independent advisor, collaborating with international companies. She has participated in clinical trials for rare diseases and advanced therapies, such as CAR-T cell therapy and cancer vaccines, with clinical sites in the US and EU. Her work has included signal detection activities, creation of safety documentation, including Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMPs), preparation of patient narratives, clinical study reports and Module 2 summaries for submission in the US and EU.

In recent years, Alina has overseen regulatory submissions and pharmacovigilance activities in the LATAM region and several African countries, adapting to the evolving regulatory systems in those regions. A recent highlight of her work in the Middle East involved registering strategic medications through standard and abridged procedures, creating a centralized pharmacovigilance system for a global distribution company, and reviewing dossiers from companies in the CIS region to align them with GCC registration requirements.

As a GxP auditor, Alina supports companies worldwide by providing audits and training, preparing them for inspections and qualifying them for partnerships. Her dedication to pharmacovigilance is demonstrated by her active participation in forums, conferences and training programs. Recently, in the GCC region, she has covered topics on AI applications in pharmacovigilance, a field she strongly believes in.

Alina’s true passion lies in clinical trials, which she is eager to pursue further in the GCC region. This will enable her to apply her extensive knowledge and make a meaningful impact on the evolving healthcare landscape in the area.