MISSION ON STRENGTHENING ASSESSMENT CAPACITY HAS BEEN ORGANIZED

During the week of 17-21 of September 2018 the mission on the Strengthening Assessment Capacity within the Activity 5.1 of the EU funded Twinning project “Strengthening of the Medicines and Medical Devices Agency of the Republic of Moldova (MMDA) as regulatory agency in the field of medicines, medical devices and pharmaceutical activity” has been organized. 

During this mission, the Short Term Experts from the States Medicines Control Agency under the Ministry of Health of the Republic of Lithuania and the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of the Republic of Poland, carried out the training on Scientific Assessment of Medicinal Products in the Europeans Regulatory Network.

The training was focused on the assessment of pharmaceutical, preclinical, and clinical dossiers. Additional discussion on problems encountered in the clinical assessment of marketing authorization dossiers took place.  

The MMDA experts and assessors were familiarised with the structure and work of European Medicines Agency (EMA). The role of expert committees, experts groups and national experts and the EMA staff was introduced. Assessment of medicines at different points of their lifecycle was explained as well as the scientific guidelines and assessment’s templates prepared by the EMA. 

In addition, the MMDA experts and assessors were trained to prepare assessment reports on the basis of the EMA guidelines and templates.

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Development and support SEMSEO

(c) 2015. Agenţia Medicamentului şi Dispozitivelor Medicale