TRAINING ON SIGNALS MANAGEMENT, ADR, PASS AND PAES HAS BEEN ORGANIZED

During 28-30 May 2018, training on Signals Management, ADR, PASS and PAES was organized at the Medicines and Medical Devices Agency of the Republic of Moldova in respect of the EU-funded Activity 2.4 “Strengthening of Pharmacovigilance by Establishing a Better Functioning Pharmacovigilance Unit”.

The Short Term Experts from the State 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, as well as representatives of the Medicines and Medical Devices Agency of the Republic of Moldova met to discuss issues on adverse drug reaction reporting and management system, assessment of suspected adverse reaction and adverse drug reaction, signal management, assessment of risk management plans and Periodic Safety Update Reports, assessment of risk minimisation measures and additional pharmacovigilance activities, such as Post-Authorisation Safety Studies and Post-Authorisation Efficacy Studies.

Possible action plan following identification of serious adverse drug reaction (and serious adverse event) as well as the principals and audience of safety communication were analysed during the meetings.

As the result of this Activity, a Plan with Goals and Milestones to Strengthen Pharmacovigilance System, as well as Key Elements of Standard Operating Procedures for Adverse Drug Reactions Reporting, Signal Management, Risk Management Plan, Post-Authorisation Safety Studies, Periodic Safety Update Reports, Suspected Adverse Reactions and Adverse Drug Reactions Assessment will be delivered to the Beneficiary Country.