Ron Ogilvie is a Senior Director and Internal CMC Advisor in Global Regulatory CMC within Pfizer, with 13 years of experience in CMC (and 10 years previous experience in Chemical Process R+D in Pfizer). Ron has experience of leading global new drug applications for Pfizer and has strong interests in impurity management (he chairs Pfizer’s Impurity Council) and Quality by Design (representing Pfizer at the EMA QbD Workshop in London in 2014). Ron has been a member of the IFAH-Europe Quality ad hoc group and has supported EFPIA activities on several topics, including the EFPIA Q11 support team (joining ICH discussions in St Louis on Q11 and working with the European focus team as Q11 was developed). Ron also joined an EFPIA group who met with EDQM on the topic of starting materials selection in June 2011 and represented EFPIA at the QWP Breakout session on API Starting materials in December 2013. He spoke on a 2013 AAPS webinar on API Starting Material selection and is currently working on an ISPE sub-team on the topic of API starting materials.