Stephan Rönninger works in Quality External Affairs at Amgen on Operations/CMC since 2013. He collaborates cross-functional internally and with external stakeholders by shaping regulatory guidelines, disseminating intelligence, and educate. He represents Amgen in EFPIA MQEG and represents EFPIA on GMPs/inspections, in ICH training and ICH-QDG and before on ICHQ9, ICH Q-IWG and ICHQ7-IWG. In PDA he was at the board and chaired the regulatory Affairs and Quality Advisory Board (RAQAB). Stephan holds a PhD / engineering degree from the Technical University Darmstadt, is appointed as Academic Visiting Expert at Duke-National University of Singapore and was Adjunct Assistant Professor at Georges Washington University. He worked for Roche in a manufacturing site and developed their Global-QMS (1992-2013). He has received numerous awards from regulators incl. APEC, PDA, and PIC/S, as well as from the agencies in Canada, Peru, Russia, South Korean, Turkey and the US-FDA.