Expertise Description
I 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
Expert Witness
My expert witness experience includes: Medical product liability; Labeling claims; Clinical studies; Food and Drug Administration regulations.
Consulting Experience
My consulting experience includes: pharmaceutical, device, and biologic companies.
Professional Experiences
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.
Education
| Degree | Subject | Institution | |||
|---|---|---|---|---|---|
| PhD | Phamacology | University of Southern California | |||
| BS | Biochemistry | University of California | Los Angeles | ||
Licenses Certifications
| Regulatory Affairs Certification (RAC) |
| Registered Quality Assurance Professionals in Good Clinical Practice (RQAP-GCP) |
Awards & Affiliation
| Recognized in Who's Who. |
Primary Affiliation
Drug Information Association
Partial List of Consulting Expert Witness Cases
SELECT EXPERT