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Axis 3 / Subject 1 - Experience of reinforcing the technical capacities of National Regulatory Authorities

Presentations:
 

Initiatives by the WHO for reinforcing the technical capacities of National Regulatory Authorities in Africa.

Speaker

Alain PRAT, inspector pharmacist, technical civil servant at the WHO (Geneva), Quality and Safety for Medicines Unit, Department for Essential Medicines and Pharmaceutical Policies (EMP), WHO Geneva.

General scheme of the Presentation
  • Analysis of the capacity of National Pharmaceutical Regulatory Authorities in Africa.
  • Tool for evaluating National Pharmaceutical Regulatory Authorities.
  • Fields for support proposed by the WHO in this sector.
Essential questions on which the presentation is based
  • Outlook for development in the sector?
  • Concentration of efforts and strategies for intervention in place?
 

Experiences in Developing ANRs

Speaker

Marie-Paule FARGIER, hospital pharmacist, freelance consultant, long and varied experience of long term and short term technical assistance in hospital medicines management, in MEG supply systems, in management of centralised purchasing authorities and in support to national pharmaceutical regulation (mainly in French speaking countries).

General scheme of the Presentation
  • The history and characteristics of regulating the pharmaceutical sector are very different in French speaking and English speaking Africa. For reasons which are essentially historical, National Pharmaceutical Regulatory Authorities have taken very different forms and play very different roles in these two distinct worlds.
  • Experience in supporting purchasing authorities are also numerous and multiform.
  • The talk traces the history and particular weaknesses of National Pharmaceutical Regulatory Authorities in French speaking countries and the support axes which could be thought of as the most important in this field.
Essential questions on which the presentation is based
  • What factors have contributed towards success, what are the difficulties and the lessons to be learnt from these experiences in numerous African countries? (based essentially on French speaking Africa)
  • What in the current situation is the outlook for development and work at the level of the National Pharmaceutical Regulatory Authorities?
  • What are the priorities for reinforcing the National Pharmaceutical Regulatory Authorities?
 

Experience of providing technical support for NRAs (MCAZ in Zimbabwe)

Speaker

Corinne POUGET, pharmacist, freelance consultant, QUAMED network, specific experience in the field of pharmaceutical regulation at the European Pharmacopoeia (EDQM, manager of the certification service at Eur.Ph. for active pharmaceutical raw materials); AEDES mission for this presentation.

General scheme of the Presentation

Description of the specific case of support provided to a Pharmaceutical Regulatory Authority in the English speaking world; appraisal of global management quality control procedures in MCAZ (Medicines Agency of Zimbabwe) - targeted technical support missions carried out as part of a support project in the medicines and health sector carried out by AEDES.

Essential questions on which the presentation is based

What are the parameters which have enabled MCAZ (Medicines Control Authority of Zimbabwe) to be operational and effective?