1. Overview of ICH GCP Syed Sarfaraz Uddin e-mail: firstname.lastname@example.org
10. The ICH Story Through the development of science-based, international guidelines and standards How: Reduce unnecessary duplication and thereby contribute to the efficiency of drug development and registration for new pharmaceuticals Why: Regulatory authorities and research-based industry of the EU, US and Japan; WHO, EFTA and Canada observers Who:
31. ETHICAL REVIEW SHOULD DEFINE JUSTIFIABLE BOUNDARIES BETWEEN THE RIGHTS OF THE SUBJECT AND THE BENEFITS THAT MIGHT ACCRUE TO SOCIETY THROUGH SCIENTIFIC INFORMATION DEVELOPED IN CLINICAL TRIALS. Regulations have been established internationally, to ensure ethical & scientific conduct of trials
33. STAKEHOLDERS & THEIR RELATIONSHIPS MONITOR DATA SUBJECT REGULATORY AUTHORITY SPONSOR ETHICS COMMITTEE INVESTIGATOR
Helsinki declaration was adopted by World Medical Assembly in 1964, amended in Tokyo in 1975, in Venice in 1983 and subsequently in Hong Kong in 1989. The most important principle being “Interests of the subject must always prevail over the interests of science and society.” However, this declaration does not necessitate informed consent for therapeutic trials and only requires documentation of reasons for not obtaining the same. The physician is obliged to preserve the accuracy of the results. Thus GCP ensures the credibility of the data.
Most of the current requirements of ethical protection are as a result of reaction by the public, scientific community and politicians in response to reports of abuse of trial subjects during 1960’s and 70’s.