Guidelines for Good Clinical Laboratory Practices (GCLP) outlines the principles and procedures to be followed by medical laboratories involved in clinical research and/or patient care so as to provide quality data which can be used for health research and patient treatment. As the use of laboratory... tests (often expensive) are increasingly becoming a part of medical diagnosis and research, generation of quality data would be a cost-effective and ethically sound strategy.
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These guidelines have been developed specifically to address ethical issues of conducting research in children.
16 Days of Activism against gender-based violence campaign ended on 10 December. A series of events organized by UNHCR and other agencies operating in the Rohingya response increased attention on issues in particular affecting women and girls: The Refugee Relief an...d Repatriation Commisisoner and camp authorities strongly collaborated with the agencies to
demonstate Bangladesh’s commitment to ending gender-based violence for refugees
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These guidelines will assist the ICMR institutions/ centers/ Hqrs. by providing information on the policies, principles and approaches which should be followed in carrying out procurement of goods and services at their respective institute/ center/ Hqrs.
The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells... of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development. The guideline therefore focuses on: 1. Monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation. 2. Procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution. 3. Other important areas like international collaboration, exchange of cell/lines and education for stakeholders and advertisement.
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Pre-Publication draft version. Lat reviewed on 7th July 2017
The objective of this document is to guide the preparation and implementation of national preparedness plans for the safety of substances of human origin during outbreaks of Zika virus infection, both in affected and non-affected areas.
In preparing this paper, the Pharmacovigilance Group of the Pan American Health Organization’s Pan American Network for Drug Regulatory Harmonization (PANDRH) adopted the perspective of PAHO/WHO, which considers Pharmacovigilance, an essential component of public health programs. Its intention was... to facilitate the development of pharmacovigilance systems in the Region of the Americas and improve, strengthen, and promote the adoption of good practices to improve safety for patients and the general population, based on the needs of the Region.
Document also available in Spanish and Portuguese!
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