Join Afrodita Bijelic, PhD, MTOPRA, for an exclusive session exploring regulatory requirements, progress, and opportunities across the Western Balkans. 

Suitable for:

Regulatory dossier specialists, managers, senior managers, directors, project managers, regulatory leads, business managers involved in deciding which new market to include in the Marketing Authorisation Application (AA) submission strategy.

Benefits to participants:

Gain a clear overview of Marketing Authorisation Application (MAA) requirements for medicinal products in Albania, Bosnia & Herzegovina, Kosovo, Montenegro, North Macedonia, and Serbia. Discover how EU alignment and the Common Regional Market are transforming pharmaceutical access and investment in the region. You will also learn how to streamline Marketing Authorisation Applications using reference market CTD formats while addressing local Module 1 requirements. 

This is a unique opportunity to gain practical insights into the regulatory landscape, key initiatives, and opportunities shaping pharmaceutical access and growth in these markets.

Speaker

Afrodita Bijelic, PhD, MTOPRA of Rainbow Regulatory Affairs, is an award-winning, solution-orientated regulatory affairs professional and independent consultant with 20 years of global experience in the pharmaceutical and biopharmaceutical industry. Her Expertise covers the full lifecycle of clinical trial applications (CTAs) and marketing authorisation applications (MAAs) across EU (MRP, DCP, CP, national) and ex-EU markets (national), as well as IND/sBLA filings in the US and MAAs for the rest of the world. Afrodita is skilled in regulatory intelligence, gap analysis, and strategy development, delivering high-quality submissions while building strong relationships with health authorities and cross-functional teams to support both scientific and commercial objectives.