Expert No. 59110 – CA(S)
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Expertise Description: Ph.D. - Pharmacologist specializing in pharmaceutical development. 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. Lecturer, instructor, multiple publications. Certified, National Institutes of Health (N.I.H.), Research Training Course. Expert witness consultations, depositions, and courtroom testimony.
Areas of Expertise:
Representative Litigation Experience:
- Medical product liability.
- Labeling claims.
- Clinical studies.
- Food and Drug Administration regulations.
Representative Consulting Services and/or Projects:
Pharmaceutical, device, and biologic companies.
Pharmaceutical, device, and biologic companies.
Licenses & Certifications:
| Regulatory Affairs Certification (RAC) |
| Registered Quality Assurance Professionals in Good Clinical Practice (RQAP-GCP) |
Education:
| Degree | Subject | Institution | |
|---|---|---|---|
| PhD | Phamacology | University of Southern California | |
| BS | Biochemistry | University of California, Los Angeles |
Professional Appointment/Association Affiliations:
- President of firm that provides consultation for product development, regulatory affairs, strategic planning, clinical research, and computer technology.
- Teaching experience at numerous universities.
- Drug Information Association
- Regulatory Affairs Professional Society
- Society for Quality Assurance
Awards & Honors:
| Recognized in Who's Who. |
Other Career Highlights:
| Multiple abstracts and papers. |
