SubscribeThe Drug Information Association (DIA) and the Sociedade Brasileira de Medicina Farmaceutica (SBMF) will jointly sponsor the 3rd Annual Latin American Congress of Clinical Research from September 25-27, 2006, in São Paulo, Brazil.
The Drug Information Association (DIA) and the Sociedade Brasileira de Medicina Farmaceutica (SBMF) will jointly sponsor the 3rd Annual Latin American Congress of Clinical Research from September 25-27, 2006, in São Paulo, Brazil.
This year's Congress will open with an advanced, one-day Good Clinical Practices (GCP) for the Clinical Research Professional training course, followed by two days of interactive presentations dedicated to ICH and FDA updates, Latin American regulatory guidelines and ethical issues, infrastructure and components of clinical research, and perspectives for the development of clinical research in Latin America.
The first day's training course will include learning modules specific to subject safety, regulations, and the practicalities of performing research studies.
Topics will include drug development and the entities and personnel involved; regulations that support GCP and the ethical conduct of clinical trials, specifically human subject protection; informed consent and expectations of investigators and staff; preparation, conduct, and completion of a clinical investigation from the perspective of the investigator and study site; U.S. regulatory requirements, ICH guidelines, and industry best-practices for study conduct, specifically focusing on proper adverse event reporting and documentation of trial data; and expectations of the investigator and site during sponsor audits and FDA inspections.
Following the training course, representatives from the U.S., Argentina, Germany and Brazil, Chile and Mexico will facilitate discussions on pharmacovigilance and risk management, the regulatory environment of challenges involved with clinical research in Latin America, and strategic aspects of clinical research in Latin America.
In addition, concurrent sessions will be held on Education in Clinical Research/Oncology Trials, Financial and Legal Issues in Clinical Research/Vaccine Development, Ethics Committees in Latin America/CRO-Sponsor Relationship, and Selection of Research Sites/Priorities in Clinical Research.
Register online at http://www.sbmf.org.br by August 18, 2006 and save $100 on both the Good Clinical Practices (GCP) for the Clinical Research Professional training course and the Congress.
The pre-Congress training course is limited to 60 participants. Simultaneous translation in both Portuguese and English is available. For more information, contact Julie Ho in the U.S. at (215) 442-6179 or Julie.Ho@diahome.org.
Outside the U.S. call 55-11-5587-5232 or email managingeventos@uol.com.br. Media interested in attending the event or arranging for pre- or post-event interviews should contact Heather Cable of Toplin & Associates, Inc. at (215) 793 4666 or heather@toplin.com