Emanuele Lanci

Education

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  Missione CRA

  2023 - 2023

  "Missione CRA" - 50 hours Clinical Research training course as per the Ministerial Decree 15.11.2011 Certified

  Main Topics are Methodology and Regulation of clinical trials; Good Clinical Practice (ICH-GCP);Standards for Good Manufacturing Practice (GMP); Pharmacovigilance; Quality Systems and Quality Assurance (QA); Focus on Phase 1 Quality; Tasks of Monitors referred to paragraph 5.18 of Annex 1 to the Ministerial Decree July 15, 1997 (including Pre-Study Visit, Site Initiation Visit, Site Monitoring Visit and Close Out Visit); Tasks of Clinical Research Coordinators; Focus on Regulation (EU) N°… Show more Main Topics are Methodology and Regulation of clinical trials; Good Clinical Practice (ICH-GCP);Standards for Good Manufacturing Practice (GMP); Pharmacovigilance; Quality Systems and Quality Assurance (QA); Focus on Phase 1 Quality; Tasks of Monitors referred to paragraph 5.18 of Annex 1 to the Ministerial Decree July 15, 1997 (including Pre-Study Visit, Site Initiation Visit, Site Monitoring Visit and Close Out Visit); Tasks of Clinical Research Coordinators; Focus on Regulation (EU) N° 536/2014; Workshop on Site Selection, Pre-Study Visit, Essential Documents, Drug Accountability; Site visits simulation (PSV, SIV, SMV and COV). Show less

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  Università di Roma Tor Vergata

  2016 - 2023

  Laurea Magistrale LM Biotecnologie mediche 108/110