Paul A. Gustafson

2022 PIC/S Chair, Sr. Corporate Regulatory Compliance & Enforcement Advisor, Regulatory Operations and Enforcement Branch (ROEB), Health Canada

Mr. Gustafson is currently the PIC/S Deputy Chair and has been a member of the PIC/S Executive Bureau as Chairperson of the PIC/S Sub-committee on Harmonisation of Good Manufacturing and Distribution Practices (GMDP) since January 1, 2014. The Pharmaceutical Inspection Co-operation Scheme known as PIC/S is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any Authority having a comparable GMP inspection system. PIC/S presently comprises of 54 Participating Authorities coming from all over the world (Europe, Africa, America, Asia and Australasia).

Paul is also a Senior Corporate Regulatory Compliance and Enforcement Advisor within the Regulatory Operations and Enforcement Branch of Health Canada. The Health Product Inspection and Licensing Division within this branch supports the assessment of GMP compliance of establishments engaged in various activities relating to veterinary drugs, human drugs, and active pharmaceutical ingredients.

Paul’s background includes 17 years of experience within Health Canada that has been complemented with 10 years of pharmaceutical industry experience. He has gained a wealth of industry related skills through various quality related positions ranging from quality control chemist positions to vice president, quality and compliance.