Journal of Bioequivalence & Bioavailability
Open Access
ISSN: 0975-0851
+32-466-902163
ISSN: 0975-0851
+32-466-902163
Guillermo Maligne
Chief Clinical Research Management
Gador S.A, Argentina
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.
Pharmaceutical Medicine Specialist. ï· Psychiatrist Specialist. ï· Infectious Diseases Specialist. ï· Responsible for the conduction for more than 10 projects in clinical research, including Oncology, Psychiatry and Metabolism. ï· Management of pharmaceutical products at development. ï· Management of more than 10 CRAs for Argentina, Chile and Brazil. ï· Medical Scientific Liaison for Sponsor and researchers. ï· Medical Scientific Liaison for marketing and research & development department. ï· Trainer for Physicians and CRAs for various medical topics including Biosimilar and Bioequivalence studies. ï· Reviewer of promotional materials for physicians and volunteers. ï· Medical advisor on regulatory affair for Latin America. ï· Strategic medical advisor for medical device registration. ï· Speaker at conferences and meeting for clinical trial projects. ï· Responsible for defining the clinical trial strategy and management for all clinical studies. ï· Responsible for the overall success for a FDA inspection that served for a product registration at US.