Award Winner (2024, Honorary Membership) 2023: Stephan K. Rönninger, PhD
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About Stephan K. Rönninger, PhD
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 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 on Q8/Q9/Q10 and ICHQ7-IWG. In PDA he was at the board and chaired 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 PDA and regulators incl. FDA and PIC/S.