Prof. Romaldas Maciulaitis

As the university medical clinical pharmacologist I have introduced and developed a new licensed medical speciality (medical clinical pharmacology) in my country since 1989. There are 10+ newly licenced specialists in 2023. Majority after the newly established 4 year specialised medical residency program. As the clinical and regulatory expert of the Lithuanian State Medicines Control Agency (SMCA) serve for scientific evaluations of national and European marketing authorisations, variations, referrals, and other clinically related procedures since 1992. Representated Lithuania in scientific committees at EMA during 2004 – 2022 (member of the Committee for Medicinal Products for Human Use and 2009 – 2022 in Committee for Advanced Therapies). Was a member of the national Council for Marketing Authorisation for 10+ years and chaired the Council for 5+ years. Contributed to number of public task forces: Ad hoc working groups for national legislation and implementation of EU law in medicines and bioethics (1994-2009), contributed to Efficacy Working Party (EWP) 1998 – 2022 (since 2011 – Rheumatology-Immunology WP (RIWP), 2018 – 2022 vice chair of RIWP)); had 20+ (Co-) Rapporteurships for scientific evaluations of European centralized marketing authorisation applications serving as (Co-) Rapporteur and assessor for pharmacokinetic, pharmacodynamic, and clinical parts; five Rapporteurships or contributions to European guidance documents on development of medicinal products (Solid Organ Transplantation, Progression of Renal Failure, Cell Based Medicinal Products, Tissue Engineered Products, Stem Cell Therapies, Cartilage regeneration); 150+ scientific and regulatory advises in Scientific Advise Working Party (SAWP) of the EMA and SMCA (2017-2022); eight scientific advises in biomarkers qualification procedures; contributed to Cell Based Working Party (2007-2012). Led Module in Cooperative European Medicines Development Course (IMI/EC) and serve as professor of clinical pharmacology and clinical pharmacy in LUHS. As the practicing nephrologist – serve to LUHS Kaunas Clinics and employ my knowledges to renal medicine and the areas where there is no approved and evidence based practice guidances, especially in such as treatment of patients in case of acute kidney injury, treatment of renal patients with various constantly evolving renal replacement modalities. As the practicing medical clinical pharmacologist – serve to LUHS Kaunas Clinics, where help medical colleagues from other specialties in such cases as in my renal area.

Board certifications