Namibia guideline for submission of applications for registration of pharmaceuticals for human use in common technical document format.
These guidelines have been developed to provide guidance to the Ministry of Health in managing applications for registration of human pharmaceutical products in Rwanda. It was compiled by the Technical Working Group (TWG) on Medicines Evaluation and Registration (MER) of the East African Community M...edicine Regulatory Harmonization (EAC MRH) Project. The group relied on their experiences and knowledge on medicines registration requirements of their individual Countries. World Health Organization (WHO) and the International Conference on Harmonization of Technical Requirements of Medicines for Human Use (ICH) and other available literature.
more
The primary aim of this assessment is to evaluate current approaches to malaria surveillance in Myanmar and to provide a set of practical and feasible recommendations to further strengthen the surveillance system in the short to medium term. The assessment focuses on the surveillance of malaria case...s (as distinct from more general surveillance to support monitoring and evaluation) and, more specifically, on instruments and systems to collect, collate, report and analyse malaria data as a basis for informing malaria control policy and practice.
more
Be-Friended to the Volcano : a guidance or manual book for school children in Indonesia of health crisis prevention during the natural disaster
Overuse of antimicrobial agents occurs globally in both community and hospital settings. Misuse of antibiotics can lead to a variety of adverse outcomes, including the development of antimicrobial resistanceand increased cost of hospitalization. This issuehas been particularly problematic in de...veloping countries, where antibiotic-management programs rarely exist and where antibiotics can be purchased without aprescription. In Thailand, the rate of antibiotic resistance among gram-positive and gram-negative or-ganisms has increased significantly over the past decade. These findings provide compelling evidence ofthe need for more-rational use of antimicrobial agents in Thailand.
Clinical Infectious Diseases2006; 42:768–752006 by the Infectious Diseases Society of America.
more
WHO/HIV/SIP
Accessed: 28.11.2019
Session V: Regulatory & quality assurance aspects
Update on prequalification of ARVs and regional harmonisation of medicine registration
Deusdedit K. Mubangizi
Group Lead, Inspections, WHO-PQT E-mail: mubangizid@who.int
Acknowledgements:
• Matthias Stahl
• Milan Smid
• Antony Fake
...• Jacqueline Sawyer
• Iveta Streipa
D-Building – UNAIDS
Kofi A. Annan Meeting Room
Wednesday, 9 March 2016 11:15 – 11:30
more
Journal of The Association of Physicians of India, Vol. 63 November 2015,, pp.77-96
Web page access : 28.04.2017
Guidance for the prevention of volcanic ash rain: before, during and after the ash rain
This infographic from APIC helps patients and families better understand their role in preventing infections and includes a list of questions to ask their healthcare provider about antibiotics.
Irresponsible pharmaceutical companies fuel the proliferation of superbugs through supply chain pollution, the European Public Health Alliance (EPHA) reports. The advocacy group uncovered lapses such as dirty production and inadequate waste disposal in the production of antimicrobials in China and I...ndia, which supplies most of the antimicrobials consumed in Europe. In a briefing detailing the pollution, the EPHA urges major purchasers of antibiotics to blacklist irresponsible pharmaceutical companies, demand that the industry clean up its supply chain, introduce greater transparency on the origin of antibiotics, and review and revise procurement policies from an ethics perspective.
more
The occurrence of a high percentage of couterfeit medicines on the global medicines market is often attributed to a lack of effective regulation and a weak enforcement capacity. This review, while focusing on counterfeit medicines and medical devices in developing countries, will present information... on their impact and how these issues can be addressed by regulation and control of the supply chain using technology appropriate to the developing world.
more
User GuideThe toolkit is composed of three sections: Hospital and Health System Resources - includes a readiness assessment tool, the starting point in developing or enhancing a successful Antimicrobial Stewardship Program (ASP). The tool, a checklist developed by the CDC, should be shared with se...nior management, a senior leader for quality, purchasing directors, clinic managers, nurse managers, key physician leaders, risk managers, pharmacy leaders, infection preventionists and hospital epidemiologists, laboratory staff and information technology staff. For ease of use, it is divided into two sections, one for those just beginning a program, the other for those who wish to enhance an existing program. Clinician Resources - includes webinars, clinical evidence supporting appropriate use of antibiotics, implementation guides and related articles.Patient Resources - includes frequently asked questions, pamphlets and handouts on how patients can best engage in their care and resources on appropriate use of antibiotics.
more
Exciting new treatment approaches make the management of hepatitic C one of the most rapidly developing areas of medicine. The Flying Publisher short Guide to Hepatitis C is an up-to-date source of information for physicians, residents and advanced medical students.
The prevalence, availability, and use of antimalarial medicines (AMLs) were studied in six Cambodian provinces along the Thai-Cambodian border. The study was divided into two parts: the first looked at the quality of AMLs available in Pursat, Pailin, Battambang, Bantey Meanchey, Oddar Meanchey, and ...Preah Vihear and the second obtained information about the availability and use of AMLs.
more