Peter E. Smith, PhD
President
PhD in
Pharmaceutics from Temple University with extensive academic training in Pharmaceutical
Quality Assurance and Regulatory Affairs.
Eighteen years of
experience within the pharmaceutical industry at both Research and Quality Assurance
levels.
Adjunct Professor,
Temple University, Department of Pharmaceutics, Regulatory Affairs/Quality Assurance
Program
International and
domestic auditing experience involving pre-clinical facilities and activities along with
clinical investigational sites, sponsor activities (study documents, clinical study
reports), and contract research organizations.
Training programs
designed and implemented for clinical research and quality assurance.
Computer validation
expertise from both a quality assurance and a systems development perspective.
Research and
development systems audits and analysis that include clinical data management, statistical
applications programming, clinical study report writing, and regulatory submissions.
Extensive
experience in the Quality Assurance and Clinical Research Development of pharmaceuticals
within the following therapeutic areas:
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