International Course on Clinical Research SBMF

Clinical research is considered to be one of the main driven forces of health sector development in developed countries.

This course will be relevant both for those wishing to gain an overall understanding of clinical trials (the main engine in clinical research setting) before moving into the field and for those who have general or specialist experience in this area and aim to broaden their role in the design, management, analysis, and reporting of clinical trials.

Course Objectives:

The course would aim to provide Medical Doctors; Clinical Investigators and Research Professionals with a theoretical understanding of the issues involved in the design, conduct, analysis, and interpretation of randomized controlled trials of health interventions. Attendees would be trained to develop skills to scrutinize information, to critically analyze and carry out research. An extensive discussion with the main stakeholders in the Brazilian clinical research arena will be provided.

Opening

Jorge Kalil - Instituto Ciências HAOC

Karlheinz Pohlmann - Hospital Alemão Oswaldo Cruz

José H.Fay - Hospital Alemão Oswaldo Cruz

Pedro Chocair - Hospital Alemão Oswaldo Cruz

Gustavo Kesselring - IC HAOC SBMF

Clinical statistics for non statisticians

Pfizer USA ( John Orazem; Paula Abreu; Dalia Wajsbrot)

Pharmacogenetics and the promise of personalized medicine

Mara Aspinall - Genzyme USA
Chair: Aline Guerra - Pfizer Brazil

Institutional Review Board (IRB/CEPs) issues: an International Perspective
Chair: Patricia Andreotti - ANVISA Brazil
Co-chair: José M. Neves - Hospital Alemão Oswaldo Cruz

IRBs Training programs in USA
Gary Chadwick - Rochester University USA

CEPs Training program in Brazil
Sonia Maria de Oliveira Barros - CONEP.Brazil

How to improve an IRB/CEP performance 
José Osmar Medina - UNIFESP.Brazil

Trial design technology
Chair: Hans Dohmann  - INC Fundacor Brazil
Co-chair: José L. Tavares -  Roche Brazil

Observational Research : what we can learn for clinical practice
Pedro Aguiar - Eurotrials Portugal

Adaptive clinical trial design : pro´s and con´s
Marcelo Vaz - ICON Brazil

Validity of biomarkers and surrogate end-points
Desai Bhardwajb - Kendle USA

Regulators and clinical research
Chair: Adib Jatene -  H Cor Brazil 
Co-chair: João Massud - UNIFESP Brazil

New regulations in clinical research in Brazil
Jorge Samaha - ANVISA Brazil

Government initiatives of infrastructure for clinical trials
Nadine Clausell - UFRGS Brazil

Clinical research and public policies
Dr. Itajaí Oliveira de Albuquerque - MS.DECIT.Brazil

Clinical Research : training and learning 
Chair: Marco A. Zago - CNPQ Brazil
Co-chair: Jaderson Lima - Sanofi-Aventis Brazil

Becoming a clinical investigator 
Artur Beltrame Ribeiro - UNIFESP Brazil

Training programs for clinical investigators
Roberto Stirbulov - Fac. Med. Santa Casa Brazil

Learning about Trials from the Literature
Paulo Lotufo - HU USP Brazil

Clinical trials: from funding to publication
Chair: Mario José Abdalla Saad - Fappesp
Co-chair: Sonia Dainesi - Boehringer Ingelheim Brazil 

Obtaining Funding: What to Know, What to Do
Esper Kallas - Fac. Med. USP Brazil

Investigator-initiated Industry Trials
José Octávio Costa - Merck Sharp & Dohme Brazil

Getting your research published
Bruno Caramelli - INCOR Brazil

The road map for drug development
Chair: Jorge Kalil - Instituto Ciências HAOC Brazil
Co-chair: José E. Neves - AstraZeneca Brazil

Translation research: from bench to public health
Luisa Villa - Instituto Ludwig Brazil

Current challenges in drug development 
Christopher Milne - TUFTS University USA

Early drug development in a start-up company
Fernando Perez - RECEPTA Brazil

Clinical trials and practical issues
Chair: Flávio Vormittag - USPharmacopeia Brazil
Co-chair: Marcelo Lima - PPD Brazil

Patient recruitment and retention plan: global strategies
Charles Schmidt - PRA Intl. USA

How to negotiate contracts in clinical trials
Luís Russo - CCBR Brazil

New Technologies in CNS clinical trials
Erich Mohr - MedGenesis Canada

Trends of globalization in clinical trials
Chair: Gustavo Kesselring - IC HAOC SBMF Brazil
Co-chair: Vitor Harada - ICON Brazil

Risk Management in Clinical Trials
Irene Fermont - Shield RM.France

Clinical research mapping worldwide
Ricardo Pietrobon - Duke University USA

The future of clinical data in clinical research
Rebecca Kush - CDISC USA