CLINICAL STUDY DESIGN AND ANALYSIS EXPERIENCE
Pre-clinical / Design and analysis of experiments, shelf-life stability
I / SmPC, SOP, protocol, CSR, SAP, design, analysis, reporting of safety, tolerability, bioavailability, PK/PD, bioequivalence, efficacy, noninferiority; TQT studies
IIa,b / PoC, dose-finding, communication with authorities
IIIa,b / Design, analysis, reporting of pivotal studies, safety and efficacy analysis, submission of documents, medical writing, publications
IV / Design, analysis, reporting of PMSs, IISs, PIL, medical writing, publications
Other / Epidemiology, technology assessment, medical devices, HEOR, RWE
Regulatory affairs / Development of MAA/NDA for EMA, pre-IND and IND to ND for FDA, submissions including DCP, MRP, CP, and national applications; PIL, generics and OMPs
Drug safety, Pharmaco-vigilance / Data capture for drug safety, AEs, SAEs, ADRs, SUSARs, assess causality, benefit and risk. Evaluate Case Safety Reports. Participate in signal detection, signal prioritization, risk analysis. Use ICD-10, MedDRA, WHO, TNM, Recist 1.1 classification for NSCLC
Medical writing / SmPC, eCSR, TOC, assigned protocol, granular eCTD, eCRF, Informed Consent, Randomization Scheme, SAP, PK/PD, Appendices, papers
SELECTED THERAPEUTIC AREA EXPERIENCE
Cardiology / ECG analysis, atherosclerosis, MI, arrhythmias. Cardiac safety, TQT studies
CNS / Addictions, genetic polymorphism, multiple sclerosis, stroke; pain scales, VAS, EQ-5D, SF36
Endocrinology / Oxytocin, vasopressin, renin-angiotensin-aldosterone system, diabetes mellitus
Immunology / RA, ITP with a recombinant mAB. Safety and efficacy of mAB targeting CD20, ACR20 resp.
Oncology / Breast, colorectal, kidney, skin cancer, leukaemia, NSCLC. Cancer registry
Pulmonology / Asthma, COPD, NSCLC
Medical devices / Embryo development using media
Translational Medicine / Vasopressin V1/V1a, V3/V1b and V2 receptors and oxytocin receptor ligands. Tumor marker utility of cathepsin B, cathepsin L, CEA and CA 19-9 in colorectal cancer. Pathways in RA. T cells, B cells and interaction of pro-inflammatory cytokines, esp. TNF-α, IL-6 and IL-1; CRP
Urology / Ureteric stones. Renal transplantation. Number of potential donors from vital stats
Selected references
2017 / Abdelmegeid et al. Radiographic assessment of pulmonary fluid clearance and lung aeration in newborn calves delivered by elective Caesarean section. Reprod Domest Anim. Dec;52(6):939-944. Epub 2017 May 30. PMID: 28560819, DOI: 10.1111/rda.12998
2016 / Molnar Bayesian methods in medical science. (In Hung.) Lege Artis Medicinae, 26(1-2):33-47.
2015 / Hardarson et al. Noninferiority, randomized, controlled trial comparing embryo development using media developed for sequential or undisturbed culture in a time-lapse setup. Fertil Steril. Dec;104(6):1452-9.e1-4. doi: 10.1016/j.fertnstert.2015.08.037. Epub 2015 Sep 25.
2008 / Herszenyi et al. Tumor marker utility and prognostic relevance of cathepsin B, cathepsin L, urokinase-type plasminogen activator, plasminogen activator inhibitor type-1, CEA and CA 19-9 in colorectal cancer. BMC Cancer, 8:194.
2003 / Romics et al. The effect of drotaverine hydrochloride in acute colicky pain caused by renal and ureteric stones. British Journal of Urology International (92):92-96. Blackwell Publ.