Dr. Antonio Steardo, a pharmacologist with international experience in drug safety evaluation and pharmacovigilance management, supports companies, professionals, and institutions in analyzing adverse reactions, identifying drug interactions, and managing clinical risk. Thanks to his expertise in pharmacology, pharmacoepidemiology, and regulatory law, he offers specialist consultancy to improve therapeutic safety, optimize pharmacotherapy, and ensure compliance with competent authority requirements.
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Medicinal product safety
Fundamental principles to ensure that drugs intended for human use are effective and safe. Includes evaluation of the risk-benefit profile, understanding toxicity mechanisms, and analyzing preclinical and clinical data necessary for authorization.
Adverse drug reactions (ADRs)
Study of the mechanisms underlying ADRs, from dose-dependent toxicity to immune-mediated reactions. Signal analysis, event classification, identification of vulnerable populations, and causality assessment to improve therapeutic safety.
Drug interactions
Analysis of interactions between drugs, foods, and substances that can modify efficacy or increase the risk of adverse events. Includes epidemiology, molecular mechanisms, early detection strategies, and preventive measures to reduce clinical risk.
Principles of optimal pharmacotherapy
Application of the criteria necessary to choose the most appropriate treatment for each patient, considering efficacy, safety, interactions, comorbidities, and individual variability. Goal: maximize therapeutic benefit while reducing risks.
Pharmacovigilance
Principles and methodologies for monitoring drug safety after marketing. Includes risk management, adverse event reporting, signal analysis, pharmacoepidemiology, and implementation of risk minimization plans.
Safety in clinical trials
Bioethical evaluation of drug safety in clinical trials, integration of pharmacovigilance into study design, and preparation of documentation for marketing authorization applications.
Pharmacovigilance regulations and legislation
Knowledge of the European and international regulatory framework governing pharmacovigilance: obligations of marketing authorization holders, reporting requirements, audits, inspections, and quality system management.