Tutorials

# 1 - Hands-on in Latin America: Regulations for Clinical Trials
Director: Silvia Zieher
See the program (PDF)

# 2 - Clinical Project Management: Essential Tools to Optimize Clinical Trials Operations
Director: DIA speaker - Cris Howard (DIA tutor)
See the Program (PDF)

Opening lecture

The importance of clinical research for drug development
Richard O. Day. President elect. DIA Board of Directors. Australia

Plenary session 1

Round table:  Working for harmonization on regulations for clinical trials in Latin America

Plenary session 2

Global Challenges with Bioethics in IRB's Training

Chair: Paulo Fortes. Brazilian Society of Bioethics. Brazil
Co-chair: Marcelo Lima. GE Healthcare Medical Diagnostics. Brazil

U.S. Training Programs for IRBs: What is in Place and Is It Enough?
Marjorie Speers. AAHRPP. USA

Latin-American Experiences in IRB’s Training Programs: Brazilian experience
Miriam Ghiraldini Franco. Unifesp. Brazil 

Chilean experience
Gustavo Kaltwasser. Bioethics Consultant. Chile

Concurrent session 1

Pharmacovigilance - SAE management

Chair: Stewart Geary. Eisai Co. Japan
Co-chair: Murilo Freitas Dias – Pharmacovigilance Manager, ANVISA, Brazil

An ethical perspective - What has to be paid?
Greg Koski. Harvard. USA

SAE accountability: a legal perspective in Latin America
Claudia Senise. PRA. Brazil

How to estimate SAE costs and control/audit SAE bills
Liu Hsiang Tzu. Icon. Brazil

Concurrent session 2

Pediatric trials in Latin America

Chair: Charles Schmidt. Brazil
Co-chair: André Feher. Novartis. Brazil

Clinical research in pediatric oncology
Antonio Sergio Petrilli. GRAACC. Brazil

Trends on global pediatric clinical research
Barry Mangum. Duke   University. USA

Current Obstacles to Boosting Pediatric Clinical Research
Robert M. Jacobson. Mayo Clinic. USA

Concurrent session 3

State of the Art in Oncology Clinical Trial Design

Chair: Sergio Simon. GBCAN. Brazil
Co-Chair: Paula G. Strassmann. PGS Medical Statistics. Brazil

Trial Designs in Oncology, regular or adaptative?
Diane Young. Novartis. USA

How investigators understand new designs? What is their perception? How important is for the patients?
Max Mano. ICESP. Brazil

Statistics point of view. When and why  is important an Adaptative Design
Jeff Vest. Medpace. USA

Concurrent session 4

Conducting Observational Studies in Latin America: Academia, Ethical Committees and Pharmaceutical Industry

Chair: Laura Luchini. Sanofi Aventis. Brazil
Co-chair: João Toniolo. UNIFESP. Brazil

Organizing Observational Studies in the Region - Academic Perspective
Paulo Lotufo. USP. Brazil

Regulations and Ethical analysis of Observational studies
Ezequiel Klimovsky. FECICLA. Argentina

Organizing Observational Studies in the Region - Pharmaceutical Industry Perspective
Eduardo Forléo. Chiltern. Brazil

Plenary session 3

How the post trial access issue has progressed throughout the world in recent years

Fanny Nascimento Moura – Sanitary Point of View on Post-trial Access, ANVISA, Brazil

Chair: Sonia M. Dainesi. Boehringer Ingelheim. Brazil
Co-chair: Sonia Barros. HIAE. Brazil

Ethical aspects and challenges of post trial access to study medications
Christine Grady. NIH. USA

Legal aspects on the donation of non-approved drugs
Angela Kung. Pinheiro Neto. Brazil

Sanitary point of view on post-trial access
Fanny Nascimento Moura. Anvisa. Brazil

Plenary session 4

Translational Medicine

Chair: João Massud Filho. UNIFESP/Cristália. Brazil
Co-chair: Mariano Janiszewski. Amgen. ICB USP. Brazil

Translating Investigation of mood disorders in the treatment of the real patient
Jair Soares. UT Houston Medical School. USA

Translational medicine in sepsis: the critical role of the microcirculation
Daniel De Baker. Erasme University Hospital. Belgium

Brazilian experience on translational medicine
Luísa Villa. Ludwig Institute. Brazil

Concurrent session 5

Contract and budget negotiations: how to build a win-win relation between sponsors and sites

Chair: Marlene Llopiz. Venn Life Sciences. Mexico
Co-chair: Gustavo Kesselring. HAOC. Brazil

Perspectives from the sites
Luís Russo. CCBR. Brazil

The top 10 ways to impede the independent research site
Jeffrey Adelglass. Research Across America. USA

Partnership with sites
Mariana Pauli. PPD. Argentina

Concurrent session 6

Computerized Systems in Clinical Trials: Data quality and Integrity  

Chair: Silvia Zieher. INC Research. Argentina
Co-chair: Marcelo Vaz. Icon. Brazil

An Overview of Best Practices from PEACH
Earl Hulihan. Medidata. USA

US FDA´s Regulation of e-Records and e-Signatures in Clinical Investigations
Sean Kassim. FDA. USA

The use of cloud computing in medicine and research: A blessing of a curse - A Pratical Discussion
Glen Watt. Medidata. USA

Concurrent session 7

Effects of the 2008-09 Global Economic Crisis on Clinical Development and How Biopharma is responding

Chair: Dennis Hurley. Kendle. USA
Co-chair: Jorge Raimundo . Interfarma . Brazil

Trends in overall number of trials and sites, Global Distribution, and Disease Focus
Fabio Thiers. NBER. MIT. USA

Big Biopharma trends
Julio Camps. Amgen. USA

The Shifting Focus of Global Biopharmaceutical R&D: New Innovation Models and Strategies
Kenneth Kaitin. Tufts CSDD. USA

Concurrent session 8

The Implications of Late Phase Research on Drug Development

Chair: Oscar  Podestá. Chiltern. Argentina
Co-chair: José Tavares .Roche .Brazil

Clinical Research beyond registration
Jaderson Lima. Sanofi Aventis. Brazil

Compliance challenges in late phase projects
Daniel Ciriano. Roche. Argentina

Farmacogenomics in the Brazilian population and its implication on local clinical studies
Guilherme Suarez-Kurtz. INCA. Brazil