PHARMBICON Expert
CEO & Founder, PHARMBICON | PIL Readability Expert
Halina Zawadzka is the founder and CEO of PHARMBICON. Since 2007, she has specialised in Patient Information Leaflet (PIL) readability, combining extensive experience in readability testing with practical knowledge of Regulatory Affairs and the marketing authorisation process.
At PHARMBICON, she leads projects covering readability testing, bridging, audits and end-to-end PIL development. Her approach to readability combines the patient perspective with regulatory requirements for medicinal product information.
Before readability became her main specialism, she held senior management positions in the international pharmaceutical industry, including General Manager and Area Director for Central and Eastern Europe.
She was responsible for business development across Central and Eastern European markets and projects related to marketing authorisations for medicinal products. Her experience also includes cooperation with healthcare and regulatory institutions and managing registration projects across several CEE markets.
She founded PHARMBICON in 2005. Since 2007, the company has focused on Patient Information Leaflet readability.
Halina Zawadzka has a healthcare background and holds a Master of Science in Nursing from the Jagiellonian University Medical College. She also holds an MBA and has completed postgraduate studies in management and the operation of the pharmaceutical industry in the European market.
Member of TOPRA – The Organisation for Professionals in Regulatory Affairs.
This combination of expertise directly informs her work in readability.
Her healthcare background brings the patient perspective. Her Regulatory Affairs experience helps her place medicinal product information within the requirements of the marketing authorisation process. Her longstanding specialism in readability brings these two perspectives together.
Readability does not end with a positive test outcome.
The goal is a leaflet in which patients can find the information they need, understand it and use it correctly.
This approach became the foundation of PHARMBICON’s 3Z Method:
[ZNALAZŁ → ZROZUMIAŁ → ZASTOSUJE]
Halina Zawadzka is the author of PHARMBICON expert publications on Patient Information Leaflet readability and practical Regulatory Affairs challenges.