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Session 1A: Round-table: Accreditation of Clinical Research Sites in Latin America

Day & Time:
October 21, 2:00PM - 3:50PM

Type:
Session

Title:
Session 1A: Round-table: Accreditation of Clinical Research Sites in Latin America

Chair(s):
Diana Valencia, MD
CEO
LatAm Clinical Trials, Colombia

Flávio Carcano
Barretos Oncology Hospital, Brazil

Description:
The quality and experience of the clinical research sites are fundamental factors for being selected for clinical trials with new drugs. One of the most effective ways to demonstrate quality is to obtain accreditation by a credible institution, or the government. The movement for accreditation of research sites is evolving in many places, but Colombia has been a spearhead in Latin America, requiring that only sites accredited by the regulatory agency are involved in clinical trials in the country. This session will update the audience on the recent status of Colombian program of site accreditation, as well as bring the perspectives of the sites. A representative from the sponsors will also discuss the implications of the process for site selection and development.

Presentation(s) & Speaker(s):
How Sponsors can Help Sites to be Accredited?
Cecilia Gabarain, MD
Senior Investigator Development Lead
Pfizer Laboratories, Argentina

Pitfalls in Clinical Research Accreditation at a Private Hospital
Otavio Berwanger, MD
Director IEP
Hospital do Coração, Brazil

Latin American Initiatives for Clinical Research Accreditation
Chiu H. Chen Ogassavara
Global Clinical Operations
Janssen R&D, Brazil