alexa Editor - Guillermo Maligne | University of Buenos Aires, Buenos | 26250
ISSN: 0975-0851

Journal of Bioequivalence & Bioavailability
Open Access

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Guillermo Maligne

Guillermo Maligne
Chief Clinical Research Management
Gador  S.A.
Argentina  
Biography

Over 12 years of experience working in the pharmaceutical industry. 17 years medical development as physician. 4 years in Basic Research Project CONICET Fellowship (National Scientific Council). 8 years of experience advising Oncologist Clinical Trials in Early and Late Phases for clinical research. Phase I and Bioequivalence studies, including First in Human/Healthy Volunteers studies, generic drugs and vasoconstriction assay (VCA).President ethics committee (ad honorem) CEIINAPsi.

Research Interest

Pharmaceutical Medicine Specialist.  Psychiatrist Specialist.  Infectious Diseases Specialist.  Responsible for the conduction for more than 10 projects in clinical research, including Oncology, Psychiatry and Metabolism.  Management of pharmaceutical products at development.  Management of more than 10 CRAs for Argentina, Chile and Brazil.  Medical Scientific Liaison for Sponsor and researchers.  Medical Scientific Liaison for marketing and research & development department.  Trainer for Physicians and CRAs for various medical topics including Biosimilar and Bioequivalence studies.  Reviewer of promotional materials for physicians and volunteers.  Medical advisor on regulatory affair for Latin America.  Strategic medical advisor for medical device registration.  Speaker at conferences and meeting for clinical trial projects.  Responsible for defining the clinical trial strategy and management for all clinical studies.  Responsible for the overall success for a FDA inspection that served for a product registration at US.

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