Safety Assessment of Investigational Medicinal Products
Assessment of investigational medicinal products in clinical trials, including coordinated safety assessment, tasks and functions of saMS, CT approval guidelines, safety information reporting, and important reporting contacts. This involves evaluating safety aspects, recommending corrective measures, and handling SUSARs, ASRs, ESI, USM, and protocol deviations impacting patient safety.
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SAFETY ASSESSMENT OF INVESTIGATIONAL MEDICINAL PRODUCTS Clinical Trials Department 04.03.2022, Riga Classified as public by the European Medicines Agency${If.End}${If.App.PowerPoint}
COORDINATED SAFETY ASSESSMENT Safety assessing Member State (saMS) is a member state that assesses information regarding clinical trials involving investigational medicinal products containing the same active substance, regardless of pharmaceutical form and strength or indication investigated and regardless of whether the product is being investigated in a single or multiple clinical trials conducted by one or various sponsors, that has been submitted as information about a suspected unexpected serious adverse reaction (SUSAR) in accordance with Article 42 of Regulation (EU) No. 536/2014 or included in the submitted annual safety reports (ASR) in accordance with Article 43. Classified as public by the European Medicines Agency${If.End}${If.App.PowerPoint}
Tasks and functions of saMS SUSAR assessment saMS ASR assessment Assessment of any safety related aspect Recommendations for corrective measures Classified as public by the European Medicines Agency${If.End}${If.App.PowerPoint}
CT according to type of submission with respect to investigational medicinal product (IMP) CT approved in accordance with Directive 2001/20/EC CT approved in accordance with Regulation (EU) 536/2014 CT approved by LV in accordance with Directive 2001/20/EC and another in accordance with Regulation (EU) 536/2014 (LV is MSC) CT approved by LV in accordance with Directive 2001/20/EC and another in accordance with Regulation (EU) 536/2014 (LV is not MSC) MSC - Member State concerned CT clinical trial Classified as public by the European Medicines Agency${If.End}${If.App.PowerPoint}
SAFETY INFORMATION REPORTING CT approved in accordance with Directive 2001/20/EC ct@zva.gov.lv All SUSARs are reported as EVCTMPROD ASR ct@zva.gov.lv Emerging Safety Issues (ESI), Urgent Safety Measures (USM) and Protocol deviations affecting patient safety ct@zva.gov.lv Classified as public by the European Medicines Agency${If.End}${If.App.PowerPoint}
SAFETY INFORMATION REPORTING CT approved in accordance with Regulation (EU) 536/2014 All SUSARs are reported as EVCTMPROD ASR CTIS Emerging Safety Issues (ESI), Urgent Safety Measures (USM) and Protocol deviations affecting patient safety CTIS CTIS Clinical Trial Information System Classified as public by the European Medicines Agency${If.End}${If.App.PowerPoint}
SAFETY INFORMATION REPORTING CT approved by LV in accordance with Directive 2001/20/EC and another in accordance with Regulation (EU) 536/2014 (LV is MSC) All SUSARs are reported as EVCTMPROD ASR CTIS Emerging Safety Issues (ESI), Urgent Safety Measures (USM) and Protocol deviations affecting patient safety CTIS MSC - Member State concerned CTIS Clinical Trial Information System Classified as public by the European Medicines Agency${If.End}${If.App.PowerPoint}
SAFETY INFORMATION REPORTING CT approved by LV in accordance with Directive 2001/20/EC and another in accordance with Regulation (EU) 536/2014 (LV is not MSC) ct@zva.gov.lv All SUSARs are reported as EVCTMPROD ASR ct@zva.gov.lv Emerging Safety Issues (ESI), Urgent Safety Measures (USM) and Protocol deviations affecting patient safety ct@zva.gov.lv MSC - Member State concerned Classified as public by the European Medicines Agency${If.End}${If.App.PowerPoint}
