Expert 59110 - CA(S)


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

DegreeSubjectInstitution
PhDPhamacologyUniversity of Southern California
BSBiochemistryUniversity 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



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