Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Open this folder and view contentsHarmonization II
Close this folderProtection of trial subjects in clinical trials
View the documentCross-border movement of clinical trial subjects
View the documentCross-border movement of clinical trial subjects and regulatory communication
View the documentEthical principles and protection of trial subjects in China
View the documentRecommendations
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Open this folder and view contentsAccess to drugs and vaccines II
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Open this folder and view contentsCurrent topics
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover
 

Protection of trial subjects in clinical trials

Moderators: Dr Ramli Ghani, Malaysia, and Dr Rolf Spang, Switzerland

Clinical research is developing in terms of sophistication of scientific approach, ethical complexities, number of trial subjects, and multicountry involvement. Given the need for greater numbers of subjects, it may happen that soon much of clinical research will take place in developing country locations. However, research carried out in poor communities, particularly when funded by more affluent sponsors from developed countries, may raise complex ethical and legal questions for participants, regulators and ethics committees. Recently, many countries have either updated their Good Clinical Practice guidelines (GCP) or started more effective implementation of GCP principles. Regulators have an important role to play in protecting trial subjects. This session deals with the regulatory challenges resulting from this shift, and the need for a constantly improving regulatory framework for clinical trial management.

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