Expertise DescriptionI have over 30 years experience in pharmacology specializing in pharmaceutical development. My expertise includes: adverse experience reporting requirements; biotechnologies; clinical compliance regulations; clinical research; data management for clinical studies; device, drug, and therapy development; high-risk disease; medical devices; policy development / guidelines; product development; regulatory affairs; review and evaluation of clinical, pharmacology, and toxicology studies; and strategic planning. I have more than 5 years expert witness experience.
Areas of Expertise
My expert witness experience includes: Medical product liability; Labeling claims; Clinical studies; Food and Drug Administration regulations.
My consulting experience includes: pharmaceutical, device, and biologic companies.
My professional experience includes: President of firm that provides consultation for product development, regulatory affairs, strategic planning, clinical research, and computer technology; Teaching experience at numerous universities.
|PhD||Phamacology||University of Southern California|
|BS||Biochemistry||University of California||Los Angeles|
|Regulatory Affairs Certification (RAC)|
|Registered Quality Assurance Professionals in Good Clinical Practice (RQAP-GCP)|
Awards & Affiliation
|Recognized in Who's Who.|
Drug Information Association
Partial List of Consulting Expert Witness Cases