ENG Home Company Services News Reserved Area Contacts Links Regulatory Affairs Pharmacovigilance Market access solutions Training Services Pharmacovigilance Pharmacovigilance support for companies that intend to outsource, in whole or in part, the activities envisaged by the legislation: - Alerting and updating systems on Italian and European regulations - Assumption of responsibilities as Qualified Person / Deputy QP, availability in the absence of the Company Manager - Receipt / evaluation of ADRs (Adverse Drug Reactions) and reporting in line with current legislation - Access and periodic control of the National Pharmacovigilance Network, insertion of cases from literature of Italian origin - Screening on a weekly basis of local and international scientific literature by medicinal product / active ingredient - Registration to Eudravigilance and insertion of ICSR on behalf of the Client; entering and updating information on medicinal products (XEVMPD) - Support for the preparation of periodic safety reports (PSURs), Standard Operating Procedures (SOPs), risk management plan (RMP), pharmacovigilance system master file (PSMF) and related summary - Pharmacovigilance support during clinical trials: management of reports of serious adverse events, notification of relevant cases to the Authorities involved, registration to Eudravigilance and insertion of SUSAR on behalf of the Promoter, drafting of the Development Safety Update Report (DSUR) - Internal audits, preparation for inspections by Regulatory Authorities - One-to-one educational programs one Temas Srl Cassina Plaza Building F, staircase 2 Via Roma, 108 20060 - Cassina De 'Pecchi Milan, Italy Tel: +39 02 95794 1 Fax: +39 02 95794 435 infotemas@quintiles.com Visit the website www.quintiles.com