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
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Training leaders in public health
IMDP 2016 Training Catalogue
Editorial
Rev Panam Salud Publica 40(6), 2016
Overview
Rev Panam Salud Publica 40(6), 2016
A long and healthy life for all South Africans
From policy to practice: how the TB-HIV response is working
“The HIV community must place much more focus on TB co-infection than
it has done to date. TB takes the lives of over 1000 people living with HIV
every day, a number which is absolutely unacceptable. This report highlights that
TB d...oesn’t have to be a death sentence for people living with HIV, but we need
more action. By joining forces, the HIV and TB community can finally give this
deadly issue the attention it deserves.”
– Mike Podmore, Director STOPAIDS
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The primary role of Benin’s Department of Pharmacy and Medicines (DPMED) is to develop and apply the national pharmaceutical policy. The main objective of this policy is to ensure the availability and accessibility of quality medicines for the population. To fulfill its mandate, DPMED aims to stre...ngthen its regulatory capacity, including the issuance of licenses to pharmaceutical establishments and the registration of pharmaceutical products. Benin’s current registration system shares core concerns that are common to most developing countries, notably the capacity to evaluate and monitor the security, efficacy, and quality of medicines and other health products. It is currently characterized by 1) poor or inadequate traceability of records or regulations (example: a product’s marketing authorization [MA] is often hard to find); 2) lack of evidence used in the regulatory decision-making process (reasons behind special import authorization, i.e., products without valid MAs); 3) inconsistent and unsecured archiving system; 4) limited human resources; and 5) an inefficient information management system
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UNAIDS 2016 / Meeting Report
PQDx 0033-013-00 WHO
PQ Public Report
July/2016, version 5.0
Product:BDFACSCountTM InstrumentSystemwithFACSCountTM ControlKitandBD FACSCountTM CD4ReagentKit(AbsoluteandPercentageCD4+Counts)
Number: PQDx 0133-045-00
0133-045-00 WHO
PQDx PR
June/2016, version 2.0
12-13 December 2016
Global Action Plan on HIV Drug Resistance - Webinars 12-13 December 2016
The Zimbabwe National Pharmacovigilance Policy Handbook, 2nd Edition updates the November 2013 version to indicate the Zimbabwe National Pharmacovigilance (PV) Centre’s compliance with the WHO Pharmacovigilance Indicators Handbook 2015.
The checklist tool described in this handbook is intended for EU/EEA public health authorities who need to assess the capacity for communicable disease prevention and control at migrant reception/detention centres hosting migrants for weeks/months (medium-term) in order to identify gaps and set prio...rities for development.
Using this tool, the aim is to monitor and support capacity development to prevent the onset and improve the management of communicable disease outbreaks at medium-term migration reception/detention centres, both on a day-to-day basis and in the event of a sudden influx of migrants.
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