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Available training and certification options throughout different countries in the region
Brazil experienceCharles Schmidt MD, PhDVice-coordenador – pós graduação em pesquisa clínica
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Clinical Practice / Clinical Research
Clinical Research it is an activity of results
Clinical practice it is an activity of means
This generate natural conflicts
Course on Pharmaceutical MedicineUniversidade Federal de Sao Paulo
Degree: Pharmaceutical Medicine Specialist
Founded in 1999
Curriculum (12 modules)Biostatistics and researchEvidence based medicineMedical marketingTraining, information and promotion Legal, regulatory and ethical aspects
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Course on Pharmaceutical MedicineUniversidade Federal de Sao Paulo
Curriculum (12 modules)Experimental pharmacologyClinical pharmacologyClinical Trials Pharmacosurveillance Pharmacoeconomy ToxicologyBioavailability/ Bioequivalence
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Course on Pharmaceutical MedicineUniversidade Federal de Sao Paulo
Hours attended: 360 hrTheoretical: 260 Practice: 100
Total Career duration: 12 months
Number of graduated: 150 Attendes in 2010: 46
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Course on Pharmaceutical MedicineUniversidade Federal de Sao Paulo
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International Federation of Associationsof Pharmaceutical Physicians
founded 1975
Approved by IFAPP – CEPM
Courses on Clinical Trials in Brazil
Post-Graduate Course in Clinical Trials Santa Casa Medical School (Sao Paulo – SP)
Post-Graduate Course in Clinical Trials FOC
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Bioethics/ Moral
Do I want to do it? Can I do it? Do I must do it?
“Moral - the practice of the answers of those questions”
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National clinical research training program for academic hospitals network : a Brazilian MoH Initiative
Gustavo Kesselring
Brazilian Network on Clinical Research
Needs assessment from MOH for 19 academic hospitals ( early 2009 )
Training program for clinical research professionals How to elaborate a valid scientific question How to develop a clinical protocol Principles in Biostatistics and Data Managemnt How to develop clinical research planning and
management skills Understand GCP How to publish research results Regulations in clinical research ( Ethics and Regulatory ) Principles in Evidence Based Medicine
National clinical research training program for academic hospitals network : a Brazilian MoH Initiative
CURSO PC IC HAOC E MS
www.capacitacaopesquisaclinica.com.br
National Clinical Research Course
127 students
DECIT ( MOH ) ANVISA ( National Regulatory Agency) 9 Hospitals from Brazilian Network of Clinical Research Hospital Alemão Oswaldo Cruz
Medicine:38% Pharmacy:23% Nursing:17% Others: 22% ( Nutrition- Biology- Chemistry – Law- Economy)
National Clinical Research Course
E learning and onsite lectures
Lectures on theory are recorded live and reproduced via satellite and Internet using the Medical Connection Educational Transmission System.
Course contentBased on the "Course of Specialization in Pharmaceutical Medicine of the Federal University of São Paulo (UNIFESP),”accredited by the IFAPP (International Federation of Associations of Pharmaceutical Physicians).
National Clinical Research Course
Duration : 1 year
Classes alive : 40 ; once a week ; 1 hour duration + live discussion/chat: 1 hour
Bibliography sent by the professor
Virtual forum for discussion
4 exams (multiple choice tests )
Grade for approval : 7 /10
Conclusion• We need to certify
the trainings programs in Latin America according to our demands and necessities
• We need to plan better the continuous educational programs
• We need to keep close cooperation 23
Perguntas
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The Lord has brought drugs out of the earth;with them the physician heals a wound
and with them the apothecary compounds medicaments
Maimonides