Katarzyna Sabiłło

Partner | katarzyna.sabillo@blsklegal.com |

Partner. Lawyer. Pharmacist. Manager. An expert in the pharmaceutical market with over 20 years of experience in regulatory affairs. She has extensive regulatory experience in matters relating to medical, pharmaceutical and food law.

As a long-standing Director of Regulatory Affairs at one of the leading pharmaceutical companies, she was responsible for the ongoing monitoring of legislative changes and for supervising the proper course of marketing authorisation and reimbursement procedures as well as marketing activities.

She specialises in matters relating to placing products on the pharmaceutical market, in particular medicinal products, providing regulatory support at every stage of the product life cycle: from determining the optimal registration strategy, through the review of the documentation underlying marketing authorisation and the monitoring of the procedure, to post-marketing activities, including verification of the compliance of promotional activities with applicable regulations and the implementation of reimbursement policy.

EXPERIENCE

Marketing authorisation procedures (all types of products / all types of procedures / all types of applications).
Review of the documentation underlying marketing authorisation.
Advice on selecting the optimal registration pathway, in particular for so-called borderline products.
Applications for scientific advice.
Reimbursement and official price-setting proceedings.
Advice on selecting the optimal reimbursement strategy.
Review of the documentation underlying reimbursement decisions.
Review of internal procedures, in particular those concerning pharmacovigilance.
Assessment of the compliance of marketing and promotional activities with the applicable law.
Advice on day-to-day regulatory matters.

DISTINCTIONS

Healthcare and Life Sciences, The Legal 500 (2025)
Healthcare and Life Sciences, The Legal 500 (2026)

ACTIVITIES

Berlin-Chemie / Menarini Polska sp. z o.o. – Director of Regulatory Affairs (1997–2009)
“INFARMA” Employers’ Union of Innovative Pharmaceutical Companies (formerly: Association of Pharmaceutical Companies Representatives in Poland) – Chair of the Regulatory Affairs Group (1998–2009)
Team for the Amendment of the Pharmaceutical Law appointed by the Minister of Health – member (January–February 2006)
Faculty of Pharmacy, Jagiellonian University Medical College; postgraduate studies in “Industrial Pharmacy” – lecturer (since 2005)
Centre of Postgraduate Medical Education – lecturer (since 2024)

EDUCATION

Medical University of Warsaw, Faculty of Pharmacy, Pharmacy (Master of Pharmacy, 1995)
University of Łódź & Université Jean Moulin Lyon 3, France, Polish-French MBA Postgraduate Management Studies (Formation Franco-Polonaise de Gestion) (Master of Management, 1996)
“European Regulatory Affairs Course”, Leiden University, the Netherlands (under the auspices of the EMA) (2002–2003)
University of Warsaw, Faculty of Law and Administration, Law (Master of Laws, 2024)
University of Warsaw & Université de Poitiers, France, second-cycle studies in French and Polish business law (Master franco-polonais Droit français et européen des affaires) (Master 2, 2024)