9th Annual Biomarkers Congress
5TH LATIN AMERICAN CONGRESS OF CLINICAL RESEARCH REGIONAL PERSPECTIVES AND FUTURE TRENDS
Sheraton Hotel Buenos Aires
City Center, san martin 1225 buenos aires
Buenos Aires, Argentina
http://www.diahome.org/DIAHome/
5TH LATIN AMERICAN CONGRESS OF CLINICAL RESEARCH REGIONAL PERSPECTIVES  AND FUTURE TRENDS
Drug Information Association 
http://www.diahome.org/DIAHome/
Sheraton Hotel Buenos Aires 
Buenos Aires

Schedule of Presentations:

Thursday, November 20, 2008
08:50:00 Start of session
08:55:00 Plenary Sessions
09:00:00 Pharmacogenetic / pharmacogenomic studies
10:30:00 Break
11:00:00 Round table: Future trends on the regulations in Latin America. Where are they going to?
13:55:00 Concurrent Sessions (A , B, D and G)
14:00:00 A) Challenges in protocol designs
14:15:00 A) Adaptive designs
14:25:00 G) Role of the SMOs in Latin America. José Maini Cuneo
14:30:00 G) Logistics of clinical trials in Latin America
14:35:00 G) Drug and supplies storage and distribution. Diana Mancini, Worldcourier Latin America, Natalia , Montenegro, Fabio , Gonzalez
15:00:00 A) Conducting Phase 1 studies in Latin America. Frank LaCreta
15:00:00 G) Importation and exportation of study supplies and samples José F Rodríguez Quiñones
15:10:00 A) Biomarkers and surrogate endpoints in Clinical Trials. Towards translational medicine. Erik Sprengers
15:55:00 D) Technology tools in clinical research
15:55:00 B) Drug Safety Risk Management
16:00:00 D) Electronic Data Capture: current experience and perspectives. Edward . . Ikeguchi
16:00:00 B) Risk management. Concepts of Global Quality Risk Management / Creating a QRM environment cross-functionally for Clinical Trials. Gabriele Roth
16:25:00 D Latin America experience with EDC and use of electronic diaries in clinical trials. Luis E. Ramirez-Arizmendi
17:00:00 B) Risk minimization: the pharmacovigilance of complex drugs/ potential high risk. Ines Bignone
17:15:00 B) Safety reporting to Ethics Committees and Regulatory Agencies. Fabiana , Ibelli
17:20:00 D) Computarised systems/ medical records in clinical trials. Earl , Hulihan
17:25:00 End of Session
Friday, November 21, 2008
07:50:00 Start of session
07:55:00 Plenary Sessions
08:00:00 Morning Lecture: "Bridging the gap between different regulatory environments"
08:30:00 Regulatory framework for clinical trials in Latin America
11:00:00 Break
11:00:00 Pediatric clinical trials in Latin America
13:55:00 C) Bioavailability (BA) and bioequivalence (BE) studies
14:00:00 Concurrent Sessions (C, E, F and H)
14:00:00 C) Bioavailability (BA) and bioequivalence (BE) studies
14:00:00 E) Clinical trials in vulnerable patient populations
14:20:00 The BE/BA harmonization in The Americas. Update on the work by the BE/BA working group RED PARF/ PAHO. Justina Molzon
14:30:00 C) The BE/BA harmonization in The Americas. Update on the work by the BE/BA working group RED PARF/ PAHO. Justina Molzon
14:50:00 E) Legal and ethical aspects of the informed consent in special situations: psychiatry, pediatrics, emergency. Gyselle , Tannous
15:00:00 C) Round table: Regulating BE/BA studies in Latin America. Experience. Eduardo Johnson, Ricardo Bolaños
15:00:00 C) Round table: Regulating BE/BA studies in Latin America. Experience. Ricardo Bolaños
15:05:00 The use of placebo in psychiatric clinical trials. Maria Lopez-Bresnahan,
15:05:00 C) Conducting BE/BA studies in Latin America- a regional experience. Ethel , . Feleder
15:15:00 E) Signal enhacement in psychiatric patients Joep , . Schoemaker
15:15:00 Conducting BE/BC) A studies in Latin America- a regional experience. Ethel , . Feleder
16:00:00 H) Practical aspects in the implementation of clinical trials.
16:00:00 F) Outsourcing clinical trials in Latin America
16:10:00 The role of CROs in Latin America. Diego , Glanszpiegel
16:25:00 H) Health economics outcomes. How to measure them? Xavier , . Mesrobian
16:30:00 F) CRO/ industry interaction: outsourcing models. Silvia Zieher
17:05:00 Use of patient reported outcomes. Bill Sietsema
17:10:00 F) Outsourcing the central laboratory in Latin America Fabiola , Santelli
17:10:00 H) Strategies for patient recruitment and retention. A case study. Nancy Augensen
17:35:00 End of Session
4th Annual Pharma R&D Asia Congress
About Us | Privacy Policy | Site Map | FAQs | Advertise With Us | Community
BiotechScienceNews.com promotes research and ranks life scientists working in the life science spectrum involving biotechnology,
drug discovery, genomics, microbiology, neuroscience, medicine, pharmacology, cell biology, and molecular biology.