Stephan Roenninger Dr.-Ing. Amgen (Europe) GmbH

Stephan works in the Quality Compliance External Affairs team at Amgen on Operation and CMC matters since 2013. He collaborates cross-functional internally and with external stakeholders by shaping regulatory guidelines, disseminating intelligence, and educate. He represents Amgen in Industry associations had leading roles e.g., in EFPIA Manufacturing Quality Expert Group (MQEG), represents EFPIA on GMP/GDP & inspections and represented EFPIA in ICH for 20+ years on e.g. ICHQ9 (Quality Risk Management), ICH Q-Implementation Working Group (ICH Q8-Q11), ICHQ7-Implementation Working Group (GMP for APIs), ICH-Quality Discussion Groups incl. on Stability (ICH Q1) and ICH Management Committee Subcommittee on training as well as in IFPMA and in EUCOPE. In the Parenteral Drug Association (PDA) he represents as PDA Technical Fellow on Drug Supply and Shortage Management, was at the board, and chaired RAQAB. Stephan holds a PhD / engineering degree from the Technical University Darmstadt, was appointed as Adjunct Assistant Professor at Georges Washington University and as Academic Visiting Expert at Duke-National University of Singapore. He worked at Roche in a manufacturing site and developed their Global-QMS (1992-2013). He has received numerous awards from regulators incl. FDA, PIC/S, Health Canada and PDA (incl. honorary membership).