MISSION ON DEVELOPMENT OF GOOD GOVERNANCE PRACTICE HAS BEEN STARTED

On 14 May 2018 the first mission on the Development of Good Governance Practice within the Activity 5.2 of the EU funded Twinning project “Strengthening of the Medicines and Medical Devices Agency of the Republic of Moldova as regulatory agency in the field of medicines, medical devices and pharmaceutical activity” has been started.

During one week, the Short Term Experts from the Office for Registration of Medicinal Products Medical Devices and Biocidal Products of the Republic of Poland, and from the States Medicines Control Agency under the Ministry of Health of the Republic of Lithuania, will present the Benchmarking of European Medicines Agencies Key Performance Indicators on: Strategy and Planning, Setting Objectives and Targets, Quality Management and Quality System,  Internal Audits, Transparency, Risk Management, Conflict of Interest, Crisis Management, Operations Management, Risk Based Regulation, Assignment of Regulatory Work, Scientific Decision Making, Quality and Consistency of Assessment, Inspection and Pharmacovigilance Assessment, Opinion Making by Assessors, Inspectors and Pharmacovigilance Assessors, Decision Making by the Agency, Impact and Effectiveness of Regulation, and Clinical Trials.

Additionally, the Short Term Experts will discuss with representatives from the Medicines and Medical Devices Agency of the Republic of Moldova the rules that the Beneficiary Country applies in the area of Good Governance Practice (GGP) and the criteria applied in the Benchmarking of European Medicines Agencies (BEMA) benchmarking system of the EU medicines regulatory agencies.          

BEMA is a tool for the improvement of regulatory quality management system and consistency of best practices across the EU network of medicines agencies. The BEMA methodology includes both self-assessment and peer review assessment, and is broadly based on ISO 9004 guidelines. The main aim of the BEMA is to contribute to the development of a world-class medicines regulatory system based on a network of agencies operating to best practice standards.

During the second mission planned for October, training on the self-assessment benchmarking program established by the Heads of Medicines Agencies - Joint Human and Veterinary (HMA) will be organized.

As the result of the Activity, an analytical report on Good Governance including the evaluation of the current system will be delivered to the Beneficiary Country.

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(c) 2015. Agenţia Medicamentului şi Dispozitivelor Medicale