"Pharmacist with professional experience within Toxicology, Pharmacokinetics, Pharmaceutical R&D and Regulatory Affairs. Responsible for Non-clinical safety evaluation of drug candidates for the treatment of psychiatric and neurological brain diseases. Trained as Study Director within General Toxicology and Principal Investigator / Contributing Scientist within Pharmacokinetics in pre-clinical development. Responsiblities included design, planning, directing and evaluating pre-clinical GLP multisite toxicology/PK studies for Sponsors in the pharmaceutical industry. Experience with review and assessment of non-clinical documentation (CTD module 4) submitted in order to support drug-marketing authorization Evaluation and interpretation of clinical pharmacokinetic studies (bioequivalence, interaction and dose proportionality data) and related clinical and non-clinical pharmacokinetic data. Pharmaceutical Quality/Chemical assessment of marketing authorization applications and variations."  

Toxicology, Pharmacology, Non Clinical Develpoment, Pharmacokinetic