Biotech China 2014
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
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