Pathak et al. (2016), PeerJ, DOI 10.7717/peerj.1738; 1-14
Int J Vaccines Vaccin 2016, 2(1): 00018, January 29, 2016
The first section highlights knowledge and questions regarding security incidents, trends, and causes of violence, including around causes and motives for attacks, and tensions between individual and collective responses. The next section then explores the role of the humanitarian principles, and th...e perceptions of humanitarian actors, in affecting their security in the field. Building on this, the final section examines the protection of humanitarian action under international law, and the impunity gap resulting from effective implementation or enforcement of the law.
more
World Health Organization Country profiles 2016
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.
more
Research Article
PLOS ONE | DOI:10.1371/journal.pone.0164619 October 13, 2016
In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guidelines therefore is to assist pharmacists in ...discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
more
Three Years After Enactment of the Drug Quality and Security Act