Government

CiPharma’s training and consultancy services for public sector clients range from team training in compliance standards to consultancy in the assessment of national medicines regulatory systems and National Medicines Regulatory Authorities (MRAs).

TherapeuticAreaslarge

CiPharma support health departments in the regulation and control of medical products
such as medicines, vaccines, blood products and medical devices. Our services include deployment of  specialists with World Health Organization (WHO) assessment experience where CiPharma help governmental organizations ascertain and strengthen capability in public health promotion and protection. Our training, support and consultancy is in the areas of:

  • Assurance of medicines at the required quality, safety and efficacy,
  • Health professional and patients access to necessary information to enable rational medicines use.
  • Medicines are appropriately manufactured, stored, distributed and dispensed adequately.
  • Illegal manufacturing and trade are detected and adequately sanctioned.
  • Promotion and adverting is fair, balanced and aimed at rational drug use.
  • Access to medicines is not hindered by unjustified regulatory work.

CiPharma understand that Intensification of international commerce and increased technological complexity of manufacturing and product specifications have created additional challenges for national regulatory authorities and manufacturers, particularly to those operating in emerging countries. Our assessments of national regulatory capacity identify areas of weakness and where appropriate necessary measures are required to be taken. Assessments are conducted using standardized WHO Data Collection tools for the review of Drug regulatory Systems.

Assessments of national regulatory systems.

CiPharma undertake reviews aimed at strengthening national regulatory and control capacity through an assessment of the situation, the identification of specific needs, and the provision of appropriate technical support and training. Reviews are undertaken of the existing legal framework, regulations and control activities with regard to medicinal products and medical devices in order to assess the national regulatory capacity against a set of predefined parameters;

Our consultants work In collaboration with national officials, identifying gaps and developing strategies and corrective measures to address these gaps. They identify specific areas and activities for technical input and liaise with World Health Organization missions where appropriate.