Guido Lathouwers has 26 years of experience in the pharmaceutical industry. Within that period he was Head of Clinical Quality Assurance with worldwide responsibility for Organon. In that position he was responsible for the quality assurance programs for pharmacovigilance and GCP. Later he became Vice President for Quality Management Systems (QMS) to set up a QMS for the entire business unit of Organon. After the merger with Schering- Plough he was Head of Global Clinical Quality. Currently after the subsequentt merger with Merck, he fulfills the position of global Head Therapeutic Area Clinical Quality Management , implementing Quality by Design and Continuous Improvement through a Quality Management Model that detects, analyzes, remediates and prevents risks associated with GCP non- compliance. He is also responsible for running a risk based inspections preparations program to achieve favorable Health Authority inspections and Regulatory Filings.