TECHNICAL ASSISTANCE and ADVISORY SERVICES
Technical Assistance and Advisory Services
We offer our technical expertise to our members and partners, to national regulatory authorities (NRA) and to other technical and UN agencies and not-for-profit organisations.
In line with the QUAMED’s mission to improve access to quality medicines for all, QUAMED supports strengthening of country regulatory systems in the context of Institutional development plans (IDPs) identified as per the WHO Global benchmarking Tool.
Team Belgium and QUAMED
QUAMED is part of Team Belgium. The other members of Team Belgium are ENABEL, AFMPS, and Sciensano.
The explicit objective of Team Belgium is to provide multi-disciplinary support to national regulatory authorities. This support contributes to the NRA’s strengths to achieve a WHO maturity level or to advance from one level to another.
Currently, QUAMED is supporting the strengthening of 2 (two) National Medicines Regulatory Authorities; Rwanda Food and Drugs Authority and Direction de la Pharmacie et du Médicament, Senegal.
Team Belgium Senegal
Since June 2022, QUAMED provides a regulatory expert to the regulatory authorities in Senegal. The expert works from his home office and travels on a regular basis to Senegal.
Team Belgium Rwanda
Further, Rwanda FDA and QUAMED have signed an MoU whose underlying basis is a mutual desire to promote access to efficacious, safety and quality-assured pharmaceuticals in Rwanda through regulatory systems strengthening. The main purpose of establishing this cooperation is to foster the capacity of Rwanda FDA GMP and GSDP inspectors through their involvement in audits organised and conducted by QUAMED-validated auditors upon consent of suppliers.
Since October 2022, QUAMED provides a permanent regulatory expert to the Rwanda Food and Drug Administration. She is embedded within Rwanda FDA. Together with the QUAMED technical team she is supporting Rwanda FDA’s efforts to achieve Maturity level 3 for national regulatory systems as defined by the World Health Organisation.
Our regulatory expert works closely with the EU funded Kwigira project, managed by ENABEL. For more information on the Kwigira project, please visit this page.
Other technical assistance and advisory services activities
Other projects that we have been involved in over the past years include:
- Supporting several of our members with the development of their quality assurance policy.
- Assisted one of our members to write guidelines and standard operating procedures outlining the purpose, scope, and activities involved in specific pharmacy activities
- Produced a report for DG ECHO with the review of the provisions on medical supplies in Annex III to DG ECHO 2014 FPA and the rules applicable to Humanitarian Procurement Centres (HPCs).
- Evaluated the PERFAPPRO project, managed by ACAME
- Collaborated with the NRA in Mauritania to train and mentor their inspectors.
- Collaborated with the NRA in the Democratic Republic of Congo (ACOREP) to train their inspectors.
- Invited an inspector of the Kenyan Pharmacy and Poisons Board to join a GMP audit
- Collaborated with Village Reach to conceive and develop a register that will be used to register certified suppliers in the DRC.
Currently, we do not offer our technical expertise to pharmaceutical suppliers. We can assist a supplier by organising a mock audit that will identify the gaps in a supplier’s quality management system. However, as an inspection and auditing agency, we cannot offer advisory services to address the identified gaps.
Would you like more information about technical assistance? Or read more about our emphasis on quality