Tricia Cheney owns a consulting business providing specialized training and clinical operations expertise to the biopharmaceutical and medical device industries.
She has designed and developed numerous highly interactive training workshops that provide participants with a better understanding of the clinical research
process and its relationship to regulatory approvals.
Ms. Cheney has extensive experience directing Phase 1 through 3 clinical research trials in a wide variety of therapeutic areas in the US, Canada, and Europe.
She has been responsible for four products that have received regulatory approval for marketing. Tricia has also written and trained on standard operation
procedures (SOPs) for many biopharmaceutical and device companies.
She is on the faculty of the University of California Santa Cruz Extension where she has taught one of the elective courses in monitoring for the
Clinical Trials Design and Management Certificate Program since it began in 1999.
Tricia received her BS from Madison College in Biology/Chemistry, completed her Medical Technology internship at the University of Virginia, and has completed
29 units towards her MS in Clinical Sciences from San Francisco State University.
Contact information: Telephone 615-403-5003 e-mail:Click
here

KARIN KERBER-SMITH, BS
Independent Regulatory Consultant
Karin Kerber-Smith has been an independent regulatory consultant
since 2002. She was formerly Director, Regulatory Affairs at Pacific
Research Associates/ICON Clinical Research.
Ms. Kerber-Smith has extensive drug development experience in
the pharmaceutical industry, encompassing preclinical and clinical
research, development and execution of regulatory strategies,
and preparation and management of regulatory filings.
Ms. Kerber-Smith received her BS from the University of California,
Davis.
Contact Information: Telephone/fax 831-722-4261 email: Click
here