| Agenda At A Glance
AGENDA AT A GLANCE
SITE MANAGEMENT FULL DAY SYMPOSIUM Monday, August 1, 2011 |
| 9:15 |
Chairperson's Opening Remarks
Fidela Moreno, MD, VP, Global Development Operations, Clinical Site Management & Monitoring, ALLERGAN |
| 9:00 |
Strategic Global Trial Identification and Site Selection
Matilde DamianDirector, Clinical Research, BRISTOL-MYERS-SQUIBB, MEXICO AND CENTRAL AMERICA |
| 10:15 |
Improve the Conduct and Assessment of Clinical Trial Feasibility
Marcelo Belgrano, Clinical Study Managers, NOVARTIS-ARGENTINA |
| 11:00 |
Networking Break |
| 11:30 |
Practical Tools and Strategies to Effectively Negotiate and Contracting with Sponsors and CROs
Adriano Lago, MBA, MSc Gerente Pesquisa Clinica FUNDACAO PIO XII - HOSPITAL DE CANCER DE BARRETOS |
| 12:15 |
Strategies to Develop and Manage New Clinical Research Sites in Latin America
Bianca Dalle Olle, Site Monitor Manager BRISTOL-MYERS SQUIBB BRAZIL |
| 1:00 |
Networking Luncheon |
| 2:00 |
Obtain Tips to Attract and Collaborate with Sponsors and CROS to Secure Clinical Study Opportunities
Fernanda Aoki, Clinical Support Director Latin America, ASTRAZENECA |
| 2:30 |
Optimize the Use of Metrics to Improve Site Performance
Pilar Rodriguez, Regional Country Study Manager, ELI LILLY |
| 3:00 |
Networking Break |
| 3:30 |
Proactive Risk Management to Ensure Compliance and Minimize Financial Risk: Site Audit Readiness in Light of Increased Focus on Enforcement
Roberta Ferreira, BSN, Associate Director Global Quality Regulatory Compliance Clinical Trials and Safety, BRISTOL-MYERS SQUIBB |
| 4:15 |
Implement New Technology Solutions to Improve Your Data Management
Caroline Errobidart, Clinical Data Quality Manager, BRISTOL-MYERS SQUIBB ARGENTINA |
| 5:00 |
Pre-conference Symposium Concludes |
MAIN CONFERENCE DAY ONE Tuesday, August 2, 2011 |
| 9:00 |
Co-Chairperson's Opening Remarks
Eduardo Motti, Regional Head Clinical Operations, PFIZER–BRAZIL |
| 9:15 |
How Can Latin America Remain Competitive in a Global Marketplace?
Victor Molina Viamonte, MD, FACC, President, CAOIC-ARGENTINA
Luis Augusto Russo, MD PhD, Director, CCBR BRASIL |
| 9:45 |
Keynote Leadership Panel: Accelerate Innovation in Brazil
Gustavo Kesselring, MD, Director Clinical Operations, Clinical Research Center, OSWALDO CRUZ HOSPITAL, SÃO PAULO BRAZIL
Eduardo Motti, Regional Head Clinical Operations, PFIZER- BRAZIL
Dr. Jaderson Lima, Director for Medical and Scientific Alliance, SANOFI-AVENTIS-BRAZIL |
| 10:30 |
Networking Break |
| 11:00 |
Get Your Study Approved: Understand the Current Regulatory Requirements and Timelines for
Clinical Trials in Latin America
Fanny Nascimento Moura, Sanitary Vigilance and Regulation Specialist, ANVISA
Dr. Carlos Adriano Silva dos Santos Comissão Nacional de Ética em Pesquisa, CONEP
Agustina Visio, Directora de Evaluacion, Departamento de , ANMAT |
| 11:30 |
Regulatory Update: Latest Initiatives to Achieve Better Regulatory Timelines
Celso Arabetti, President, SOCIETY OF CLINICAL RESEARCH-BUENOS AIRES, ARGENTINA |
| 12:00 |
Networking Luncheon |
| 1:30 |
Developing True Strategic Partnership- Tips for Effective Outsourcing Relationships
Diego Martin Glancszpigel, Corporate Vice President, PARAXEL INTERNATIONAL-BRAZIL |
| 2:00 |
Improve your Provider Selection Process: Partnerships with Central Labs in the Region
Charles Schmidt, MD, PhD, Senior Consultant Eurotrials; Coordinator and Professor of the Post-Graduation Program in Clinical Research, SANTA CASA MEDICAL SCHOOL – SAO PAULO, BRAZIL and Founder and Vice-president of ABRACRO |
| 2:30 |
Lessons Learned from Establishing R&D Partnerships in Asia
Steve Yang, Vice-president and Head of Research and Development (R&D), ASTRAZENECA |
| 3:00 |
Virtual Drug Development in a Resource-Challenged Environment: Is it the Future?
Solomon Babani Vice President, Alliance Management, CELTIC PHARMA & CELTIC THERAPEUTICS |
| 3:30 |
Networking Break |
| 4:00-6:00 |
INTERACTIVE ROUNDTABLE DISCUSSIONS
- Post-Study Drug Access Provisions in Brazil
Carlos Augusto Candiotti Sanmarco, Senior Manager- Brazil Clinical Operations, ELI LILLY-BRAZIL
- Brazilian e-CRF Versus Global Market Penetration
Lia Cristina Tavares Maluf, Project Director, COREWARE
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- Ethics Issues in Latin America
Dr. Juan Pablo von Arx, Coordinator of the Central Committee of Ethics, PROVINCE OF BUENOS AIRES - Build Effective Partnerships to Success in Oncology Clinical Trials
Ana Carolina Quarezemim, Global Monitoring Operations Head for Latin America, NOVARTIS ONCOLOGY BRAZIL
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| 6:00 |
Day One Concludes |
MAIN CONFERENCE DAY TWO Wednesday, August 3, 2011 |
| 9:00 |
Chairpersons Recap of Day One
Diego Martin Glancszpigel, Corporate Vice President, PAREXEL INTERNATIONAL-BRAZIL
|
| 9:15 |
Examine Quality Assurance and Compliance in Latin America- Identify Opportunities to Improve Data Quality in the Region
Daniele Argentina, BSN,RN, Head of Regulatory & Nursing Dept, CCBR BRASIL
Cecilia Matos-Rosa, CCRP Sr. QA Auditor – GCP, AMAG PHARMACEUTICALS, INC.
Martin Valania, VP of Corporate Quality Assurance & Compliance, PHARMANET |
| 10:00 |
Best Practices in Pharmacovigilance: A Closer Look at Adverse Event Reporting in Latin America
Ola Strandberg, Vendor Liaison Officer, UPPSALA MONITORING, part of WHO INTERNATIONAL DRUG MONITORING PROGRAM |
| 10:30 |
Networking Break |
| 11:00 |
Build up Site Development Programs to Expand and Improve Clinical Research Quality in Latin America
Glauce Nunes, Director, Clinical Operations Latin America, RPS
Ana Carolina Quarezemim, Global Monitoring Operations Head for Latin America, NOVARTIS ONCOLOGY BRAZIL
Ligia Ferne, Senior Trainer, Clinical Programse, RPS RPS do Brasil Serviços de Pesquisa
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| 11:30 |
Logistics Management and Control for Clinical Trials Ariette van Strien, VP, Global Business Development, Marken |
| 12:15 |
Networking Luncheon |
| 1:15 |
KEYNOTE: The Future of Technology in a Global Marketplace: The Move Towards Personalized Medicine & The Integration of Life Sciences & Healthcare Applications
Greg Jones, Chief Technology Officer, Oracle Health Sciences |
Eduardo Motti, Regional Head Clinical Operations, PFIZER–BRAZIL
Diego Martin Glancszpigel, Corporate Vice President, PARAXEL INTERNATIONAL-BRAZIL
| 2:00 |
The Future of Technology for Data Management in Clinical Trials
Vania Solda de Jesus, Gerente de Projetos Clínicos Internacionais, Produtos Roche Químicos e Farmacêuticos S.A. |
| 2:30-4:30 |
INTERACTIVE ROUNDTABLE DISCUSSIONS
- Mitigate Legal Risks through Effective Contracts to Avoid Malpractice Lawsuits
Carlos Burger, Legal Counsel, Acting Secretary, ETHICS COMMITTEE AT MINISTRY OF HEALTH - BUENOS AIRES PROVINCE, ARGENTINA
- Emerging Opportunities in Latin America's Maturing Markets- Chile, Peru, and Colombia
Juan Luis Yrivarren MD, Research Director, CLINICAL RESEARCH SITE, CLINICA RICARDO PALMA (Peru)
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- Leverage the Use of Social Media for Clinical Research- Linkedin, Twitter, Facebook, and More
Valentina Jaramillo, Founder, HEALTH CARE SOCIAL MEDIA LATIN AMERICA - Future Developments in Generic Drug Development in Latin America
Luciano Lobo, Coordenador Técnico Administrativo – Tecnical Administrative Coordenator, Pró Genéricos – Associação Brasileira das Indústrias de Medicamentos Genéricos
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| 4:30 |
KEYNOTE: Closing Panel: The Future of Clinical Trials in Latin America |
Greg Jones, Vice President, Application Development, Oracle Health Sciences
| 5:00 |
Conference Concludes- See you next year! |
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