Markus Goese holds a Ph.D. in Biochemistry/ Organic Chemistry from the Technische Universität München (Munich), Germany. He has more than 20 years of industry experience in various companies (Roche, DSM, Novartis) in Pharmaceuticals and Fine Chemicals Research, Development and Commercialization. For the last 15 years, he has been working in CMC Regulatory Affairs, initially on Biopharmaceutical Products in early- and late-stage development. In 2011, he took on the responsibility as EU Lead CMC Regulatory Policy for Roche Pharma Global Technical Operations. Markus is based in Basel, Switzerland. He is currently Chair of EFPIA's Manufacturing and Quality Expert Group (MQEG) and EFPIA Topic Lead for ICH Q12 (Technical and regulatory considerations for pharmaceutical product lifecycle management).