Stephan Roenninger Dr.-Ing. Amgen

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 Industry associations e.g., leading the EFPIA Manufacturing Quality Expert Group and represents EFPIA on GMP/GDP & inspections and in the ICH-Quality Discussion Group and before on ICHQ9 (Quality Risk Management), ICH Q-Implementation Working Group (ICH Q8-Q11), ICHQ7-Implementation Working Group (GMP for APIs) and ICH Management Committee Subcommittee on training. In the Parenteral Drug Association (PDA) he was at the board, chaired RAQAB and represents as PDA Technical Fellow on Drug Supply and Shortage Management. 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. FDA, PIC/S, Health Canada and PDA.