Dr. Hoiberg is an Executive Director in Pfizer's Global Regulatory CMC group. He received a BS in chemistry from the College of William and Mary and a PhD in biochemistry (chemistry minor) from Pennsylvania State University. He worked for more than eight years at Sterling Drug Inc. in R&D before joining the US FDA. Dr. Hoiberg had a leadership role and held numerous positions in the Agency and was involved in many global initiatives. When he retired from the Agency, he was the Deputy Director of the Office of New Drug Chemistry and the Associate Director for International Activities. He was the CDER ICH Quality Coordinator and represented the Agency in negotiations of many ICH guidelines. He has maintained close contacts with many worldwide regulators and industry leaders. While at the Agency, Dr. Hoiberg was very involved in working with ISPE on developing the SUPAC Equipment Addendum. He has been a frequent lecturer for ISPE at its domestic and international programs in Europe and Asia. Currently he is a member of various ISPE Committees, including the Regulatory Affairs Committee, PQLI Steering Committee, and the President's Advisory Council.