13h15 charles schmidt - · pdf filebased on the "course of specialization in...

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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Misconception

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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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Curriculum (12 modules)Experimental pharmacologyClinical pharmacologyClinical Trials Pharmacosurveillance Pharmacoeconomy ToxicologyBioavailability/ Bioequivalence

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Hours attended: 360 hrTheoretical: 260 Practice: 100

Total Career duration: 12 months

Number of graduated: 150 Attendes in 2010: 46

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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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MAGI’s Clinical Trial Agreements, Budgets & Regulatory Conference 9

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2007 132008 162009 132010 11

Students

Human Rights – Attention!

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Attention: “The social control” !!!

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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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Students

118 since 2007

440 as disciplinein others programs related

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)


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).


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


1st year Program

RESULTS

40/40 classes

Approval rate : 82 %

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

[email protected]

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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

13h15 charles schmidt - · pdf filebased on the "course of specialization in...

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