Connie Langer is a Senior Director at Pfizer who leads a team that monitors and advises on regulatory changes and impacts. She collaborates with experts to communicate Pfizer's feedback and position to health authorities on regulations and guidance documents. She also has experience implementing science- and risk-based approaches and recommending strategic regulatory options to achieve product approvals globally. She is a member of the ISPE PQLI® ICH Q12 Working Team and chair of the IQ ICH Q12 Working Group. She holds BS in Chemical Engineering and an MS in Chemical Oceanography both from the University of Connecticut, and a Drug Development Certificate from Temple University.