9th Annual Biomarkers Congress
Drug Development in Latin America
The Westin Colonnade Coral Gables
180 Aragon Avenue
Coral Gables, FL
http://www.scopesummit.com/lam
Drug Development in Latin America
http://www.scopesummit.com/
The Westin Colonnade Coral Gables

Schedule of Presentations:

Sunday, February 6, 2011
13:00:00 Workshop Registration
14:00:00 Optimize the Process of Site Selection, Study Activation and Patient Recruitment
Monday, February 7, 2011
07:30:00 Conference Registration and Morning Coffee
08:10:00 REGULATORY CHALLENGES IN US, EMERGING MARKETS, AND LATIN AMERICA
08:15:00 Chairperson’s Opening Remarks
08:30:00 Regulatory Challenges and Expectations in Emerging Markets to Effective Clinical Trial Development Jerry Stewart
09:00:00 FDA Inspections of Clinical Research Sites Michelle Noemichelle.noe@fda.hhs.gov
09:30:00 Ethical Challenges in Site and IRB Selection in Multi-Regional Clinical Trials Marjorie A Speers
10:00:00 Networking Coffee Break in Exhibit Hall
10:40:00 Chairperson’s Remarks
10:45:00 Generic Drug Development in Latin America: Focus on Methodological and Regulatory Issues Francisco Estevez-Carrizo
11:10:00 Regulatory Affairs in Argentina: Challenges and Perspectives
11:35:00 Logistical and Regulatory Challenges of Importation: Getting Investigational Drug into Latin American Countries Joseph D'Antuono
12:00:00 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on your Own
13:20:00 OUTSOURCING AND PARTNERING IN LATIN AMERICA
13:25:00 Chairperson’s Remarks
13:30:00 Brazil as a Pivotal Player for Drug Development in Latin America Renato Ribeiro
14:00:00 A Case Study in “Insourcing” Regulatory & Safety In Support of Clinical Trial Execution in Latin America Chet Elias
14:30:00 Sponsored Presentation (Opportunity Available)
14:45:00 Afternoon Refreshment Break in Exhibit Hall
15:15:00 Participation of Academic Institutions as Centers of Excellence in Drug Development Research Celso Arabetti
15:45:00 How Do the Characteristics of Global Biopharmaceutical Trials Affect Participation of Centers in Latin America? Fabio Thiers
16:15:00 Sponsored Presentation (Opportunity Available)
16:30:00 Informal Break-out Discussion Groups
16:45:00 TOPIC: Latin America: A Clinical Trial Rescue Region?
17:00:00 TOPIC: Start up Challenges in Latin American Countries
17:30:00 Networking Cocktail Reception
Tuesday, February 8, 2011
07:45:00 Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee
08:20:00 PRACTICAL LESSONS FOR CLINICAL RESEARCH AND TRIALS IN THE REGION
08:25:00 Chairperson’s Opening Remarks
08:30:00 Strategies for Vaccine Development in Latin America
09:00:00 Early Phase Development in Latin America: Challenges and Opportunities Jorge Rodriguez-Larrain
09:30:00 Best Practices for Clinical Trial Planning and Implementation
10:00:00 Networking Coffee Break in Exhibit Hall
10:40:00 Chairperson’s Remarks
10:45:00 Data Integration: Latin America Teams as Part of a Global Organization Carolina Errobidart
11:10:00 The Challenge to Understand Site Selection in Latin America as a “Real Process” Marcelo Belgrano
11:35:00 Succeeding in Mexico: Lessons Learned from a Regional Director
12:00:00 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on your Own
13:25:00 End of Drug Development Latin America
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