TO THE POINT
- 25 years of experience
- PhD in physiology and biophysics
- Postdoctoral training in protein biochemistry and molecular pharmacology.
- Expert in managing regulatory issues related to medical devices, pharmaceuticals and drug delivery systems
- Extensive experience in setting up QA/RA/CA systems
- Assisted in new product development for Fujitsu America, Inc.
- Director of Regulatory and Clinical Affairs for Insulet Corporation
- VP of QA & RA for Berkeley Advanced Biomaterials, Inc.
- VP of Quality Assurance and Regulatory Affairs for Autonomic Technologies
Dr. Ian Welsford, PhD
Chief Regulatory and Compliance Office
Dr. Ian Welsford has over 25 years of experience in quality assurance, regulatory affairs, and clinical affairs dealing with regulatory issues associated with medical devices, drugs, and combination products. Dr. Welsford has extensive experience in setting up and certiying quality systems in the biotechnology, drug development, genomic, IVD, software and medical device industries. He has directed clinical trials in oncology, diabetes, metabolic disease and CNS therapies. Previously, He has held C-suite positions in quality assurance, regulatory affairs and certification authority for Palyon Medical Corporation and global regulatory and clinical strategy for Insulet Corporation.
Dr. Welsford holds a PhD in physiology and biophysics from the University of Kentucky and received postdoctoral training in protein biochemistry and molecular pharmacology.