Guidance for Industry. Oversight of clinical Investigations – A Risk-Based Approach to Monitoring (FDA)

Professional in the integration of data-driven Risk-based Quality Management (RBQM) process in international clinical trials of pharmacology. Speaker at regional and global conferences such as: DIA, Health 2.0, DGGF, etc. 18+ years of experience in data quality projects and biostatistics for the pharmaceutical industry. Life passion: improving clinical research with RbM, driving the RBQM research to new frontiers for CROs, pharma and biotech companies.