Pharma Trials: Wednesday, April 18, 2012

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last modified: 10 April '12

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Conducting global-standard clinical trials

9am

Overcoming fragmented regulatory framework in Latin America

Edson Arakaki

• 1982 – 1987 - Medicine, Universidade Estadual Paulista (UNESP).
• 1988 – 1989 – Residency in Internal Medicine HC – UNESP
• 1989 – 1991 - Residency in Gastroenterology HC Universidade São Paulo USP
• 2007 – 2010 – Executive MBA – São...

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› Edson Arakaki, Medical Director at Andean Region, Bayer Healthcare

9.30am

Ensuring site quality for FDA/EMA and local inspections

Cecilia Gabarain

Graduated in Biochemistry from University of Buenos Aires, Argentina, specialized in Biotechnology. Joined Pfizer in 2000 as a Clinical Research Associate and held positions of increasing responsibility within the monitoring area, was then appointed ...

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› Cecilia Gabarain, Director, Area Clinical Quality Lead - Clinical Operations, Pfizer

10am

Panel: strategies to faster regulatory approval

Luis Russo

Médico Pesquisador e CEO do CCBR Brasil Centro de Análises e Pesquisas Clínicas há 10 anos no mercado com mais de 40 estudos multicentricos conduzidos para as grandes multinacionais. Temos unidades no Rio e S Paulo com caracteristicas de...

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Edson Arakaki

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10.40am

Networking coffee break

Regional patient recruitment

11.10am

Benefits and challenges of recruiting study patients across Latin America

Laura Luchini

Dr. Laura Luchini is Clinical Study Unit Director at Sanofi Brazil and Coordinator and Professor of the Post-Graduation Program in Clinical Research at Santa Casa Medical School in Sao Paulo, Brazil. Dr Luchini counts +20 years of experience in...

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› Laura Luchini, Diretora da Unidade de Estudos Clínicos (CSU), Sanofi

11.35am

Positioning clinical sites to maximize recruitment success

Luis Russo

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› Luis Russo, Director, APCB - Investigators Society

12pm

Ensuring patient safety in the face of new clinical trial legislation

Andre Norio Yamada at BioPharma LatAm Convention

› Andre Norio Yamada, Medical Affairs Director, Baxter

12.25pm

Case study: patient recruitment and trial challenges for orphan drug trials

Jader Baima at BioPharma LatAm Convention

› Jader Baima, Medical, Genzyme

12.40pm

Networking lunch

Improving clinical development

1.40pm

The new role of the sponsor in LatAm clinical trials

Fabio Mataveli

Fabio Mataveli holds a MD from the State University of Campinas (UNICAMP), a PhD in Gene Therapy from the Federal University of São Paulo (UNIFESP), a MBA in Finance from Fundação Getulio Vargas (FGV) and a Specialization in Health Economics from...

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› Fabio Mataveli, Medical Director Brazil, Janssen

2.10pm

Capacity building for global clinical trials

3.10pm

Networking coffee break

3.40pm

Case study: Effectiveness vs. efficacy: the value of large, pragmatic, randomized controlled trials

Lenio Alvarenga at BioPharma LatAm Convention

› Lenio Alvarenga, Head of Clinical Operations - Brazil, Roche Pharmaceuticals

4.10pm

Panel: Creating better clinical trials in Latin America

Moderator:

Luis Russo

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MD Pedro Garbes

Pedro Garbes, M.D., has large experience in health education, healthcare, clinical epidemiology, scientific methodology, internal medicine, intensive care, evidence-based medicine, infectious diseases, clinical and epidemiological research including ...

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