Stephan Rönninger, PhD Amgen Europe

Dr. Stephan Rönninger is the 'Head External Affairs Europe, International Quality' of Amgen. He provides leadership, support and represent of external activities impacting Amgen's operations functions. He works with associations in the EU, Japan and emerging markets with focus on Russia and Turkey. He is responsible for advocacy in various external organizations and provides assessment and communication to Amgen.

Stephan Rönninger holds a PhD and an engineering degree in Organic Chemistry. After his postdoctoral studies, he worked for Roche 1992 - 2013, starting in an API manufacturing site with responsibilities for laboratory, project management, as production manager, in Quality Assurance and Quality Management. In 2003, he changed to the Roche Global Quality organization and was responsible for the Global Quality System of Roche and external collaborations.

He represents Amgen in industry trade associations (e.g. EFPIA) and the European industry on GMP/GDP topics as well as at ICH working groups such as Quality Risk Management (ICH Q9), Quality Implementation Working Group (Q-IWG), and the GMP for APIs (ICH Q7) Implementation Working Group. In the Parenteral Drug Association (PDA), he is elected for the board of directors, past chair of the Regulatory Affairs and Quality Advisory Board (RAQAB), leader of the PDA-Europe Inspections Trends Interest group and co-chairs several international conferences and training events (e.g. with PIC/S). He is one of the founders and co-chair of the 'Paradigm Change in Manufacturing Operations' (PCMO) project in PDA.