Stephan K. Roenninger, PhD Amgen Inc.

Stephan 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 education. 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 on the board of directors and chaired RAQAB.

Stephan holds a PhD in engineering from the Technical University Darmstadt, is appointed as Academic Visiting Expert at Duke-National University of Singapore and was Adjunct Assistant Professor at George Washington University. He worked for Roche in a manufacturing site and developed their Global-QMS (1992-2013). He has received numerous awards from regulators including FDA and PIC/S and the Parenteral Drug Association (PDA).