CMU | Caribbean Medical University - Faculty & Staff

Dr. Olga Rodriguez, MD.

Dr. Rodriguez graduated with an MD Degree from University of Havana School of Medicine in 1988 and post-graduate certificate in Immunology in 1993 from the same University, she also got a Master's Degree in Bioethics in 2008.

In 1997 she completed a training in Pharmaco-epidemiology at the Catalan Institute of Pharmacology of the Autonomous University of Barcelona. Dr. Rodriquez worked as a researcher and as a research methodology and research ethics instructor at National Coordinator Centre of Clinical Trials (CENCEC) in Havana from 1993 till 2009.

In 2007 she completed a fellowship from The International Union Against Cancer (UICC) at The National Council On Ethics In Human Research, in Ottawa, Canada, and she is a life member of UICC. She is also member of the Latin American Forum of Ethics Committees in Health Research (FLACEIS) since 2002 (WHO/PAHO initiative) and her papers have been published in several journals.

She has also participated in several international training and educational events as well as leaded numerous research projects.

Trainings:

1997 – Training at the Catalan Institute of Pharmacology of the Autonomous University of Barcelona (Courses Clinical Trials I and II, Methods in Epidemiology I and II, Drugs Surveillance I, and Studies of Use of Drugs I).
2003 - Training “Formation of Internal Auditors”, imparted by specialists of ININ, Havana.
2006 – Training “Formation of Lead Auditors”, imparted by specialists of ININ, Havana.

Work experience:

Clinical Research Assistant at National Coordinating Centre of Clinical Trials (CENCEC) (1993 - 1997).
Project Manager of Clinical Trials at the National Coordinating Centre of Clinical Trials (CENCEC) (1997 - 2000).
Clinical Trial Specialist - Department of Quality Management (CENCEC), Quality and Good Clinical Practices Auditor at CENCEC (2000 - 2009).
Head of the Department of Quality Management at CENCEC (2007 - 2009).
Member of Scientific Committee of CENCEC.
President and Coordinator of the Quality Committee for the Design of new clinical trials at CENCEC.
Member of the National Advisory Committee of Clinical Trials of the Ministry of Public Health in Cuba (MINSAP).
Member of the Latin American Forum of Ethics Committees in Health Research (FLACEIS) since 2002 (WHO/PAHO initiative).
Advisor of MINSAP for Research Ethics matters.
Member of the National Cuban Council of Bioethics.

Teaching Experiences:

1995 - Module Controlled Clinical Trials as part of the master of epidemiology program, IPK Institute. Havana.
1997 – National Course Actualization of Clinical Trials, Havana.
2002 - Pre-congress Course Clinical Trials, in the IV National Congress of Pharmacology and Therapy.
2003 - Basic Course of Clinical Trials for Clinical investigators imparted in Salvador Allende Hospital, Havana.
2003 - Course Clinical Trials imparted in Manuel Fajardo Hospital, Havana.
2004 - Basic Course of Clinical Trials for Clinical Investigators, CENCEC.
2004 - Replication for Cuban investigators of the course Psycho-pharmacological Research Training Program as part of the Psychopharmacological Training and Research Capacity Project funded by the CIDA-AUCC UPCDTEIR II Program, Dalhousie University.
2004 - Course Ethics Committees in Research imparted in CENCEC.
2004 - First and Second Diploma Courses of Clinical Trials imparted in CENCEC.
2004 – Workshop Bioethics and Good Clinical Practices sponsored by PAHO-WHO, in Cartagena de Indias, Colombia.
2005 – Basic Course of clinical trials for nurses. CENCEC.
2005 - Course Ethics Committees in Research imparted in Calixto García Hospital, Havana.
2006 - Course Ethics Committees in Research imparted in Joaquín Albarrán Hospital, Havana.
2006 – Course Ethics of Scientific Research as professor invited by the University of Havana.
2007 - Course Ethics Committees in Research imparted in CIMEQ, Havana.
2008 - Course Ethics Committees in Research imparted in Calixto García Hospital, Havana.

Research Experience:

Thesis: Development of monoclonal antibodies against the antigen of surface of hepatitis B Virus (1992 - 1993). University of Havana (UH).
Associate investigator of several clinical trials:
Research about Use of Drugs: “Characterization of the use of drugs in pregnancy” sponsored by the Instituto Catala de Farmacoepidemiología, Barcelona, Spain.
Research to update information about research ethics committees in Cuba in year 2003.
Fellowship from the International Union against Cancer with the project: “Improving the capabilities of ethics committees in reviewing cancer clinical trials”, developed in the National Council on Ethics in Human Research in Ottawa, Canada, from June to July 2007.
Research about the structure and functioning of research ethics committees in Havana City, June - October 2008.

Publications:

“Treatment of Rheumatoid Arthritis with Recombinant gamma interferon”, Advance in Modern Biotechnology Magazine. 1997
“Development and perspectives of Quality Assurance Program in CENCEC”. Cuban Pharmacy Magazine. 32 special issues. 1998.
“Methodology of Clinical Trials in CENCEC: Responsibility of Pharmaceutical Professional”. Cuban Pharmacy Magazine. 32 special issues. 1998.
“Ethics and Regulations of clinical investigation: Protection for subject involved in Clinical Trials”. Cuban Pharmacy Magazine. 35 special issues. 2001.
“Ethics Committees, history, actualities and controversies”. Cuban Pharmacy Magazine. 35 special issues. 2001.
“Quality of Clinical Trials Final Reports conducting by CENCEC”. Cuban Pharmacy Magazine. 35 special issues. 2001.
“Manual of Standard Operative Procedures for Clinical Trials”. Cuban Pharmacy Magazine. 35 special issues. 2001
“Quality Assurance of Clinical trials during execution phase”. Cuban Pharmacy Magazine. 35 special issues. 2001.
Good Clinical Practice Audits. Problems in Clinical Trials conducted by CENCEC. Cuban Pharmacy Magazine. 35 special issues. 2001.
“Characteristics, composition and functioning of Ethics Committees who evaluate Clinical Trials projects". Cuban Pharmacy Magazine. 36 special issues. 2002.
“Requirements for the quality of Clinical Trials”. Cuban Pharmacy Magazine. 36 special issues. 2002.
“Quality Assurance in investigation sites of clinical trials conducted by CENCEC since 2000 until 2002”. Cuban Pharmacy t Magazine. 37 special issues. 2003.
Audit to clinical investigation site: a tool to improve the quality of a clinical trial. Cuban Pharmacy Magazine. 37 special issues. 2003.
“Ethics Committees in Health Research. ¿how are we?” in the CD Room of the Biotechnology Congress Havana 2003.
“The Quality of the Clinical Research. Role of the Ethics Committees, their development and functioning in Cuba”. In “Bioethics from a Cuban Perspective”. Acosta J.R. ed. Third Edition. Publicaciones Acuario. Havana, 2007.
“State of opinions about research ethics committees in a group of professionals linked to the clinical trial process in Cuba”. Cuadernos de Bioética No. 14. Session Ensayos e investigaciones. Editorial Ad Hoc. Buenos Aires, October 2008, p 147.

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