Davide Durando Email & Phone Number

Ivrea, Piemonte, Italia

▪ Coordination of the infrastructures, services and personnel involved in the pharmacovigilance processes, in order to ensure that the System itself is constantly efficient, controlled and documented;▪ Ensure the presence of Standard Operative Procedures, with the relative records for the interventions carried out or the conclusions reached regarding: • Staff training • Deviations • Audit findings • Corrective Actions / Preventive Actions • Change Controls • Internal / External audits▪ Verification that the operations are carried out and documented according to the approved procedures;▪ Plan, carry out and verify the training for personnel involved in the Quality System for pharmacovigilance▪ Review and approve management documents relating to pharmacovigilance, collaborating in the management and participates in activities relating to the quality system of pharmacovigilance;▪ Periodically monitoring of the progress and effectiveness of the Quality Management System, in order to implement the measures necessary for its improvement;

Ivrea, Piemonte, Italia

▪ Medical sales representatives training, monitoring and activity reporting to the competent authorities▪ Advertising mediums preparation, review and approval▪ Medicines samples management▪ Scientific literature research

Ivrea, Piemonte, Italia

~ Regulatory activities related to the market entry and the maintenance of medicinal products (branded, generic, OTC) in the italian and EU market, through: • Evaluation of the projects and of the regulatory strategy • Support to the Marketing and Business Development Depts to assess the commercial potential of the projects • Analysis and mapping of the regulatory requirements of the projects • Coordination of internal and external professionals to meet the regulatory requirements • Submission of dossiers in CTD and eCTD format • Updating of dossiers in CTD and eCTD format • Submission of applications for variations (IA, IB, II) • Compliance activities (in collaboration with QA, QC departments) • Submission of applications for renewals • SPC and PL update

Ivrea

~ Regulatory activities related to the market entry and the maintenance of medicinal products (branded, generic, OTC) and food supplements in the italian and EU market, through: • Support to the Marketing and Business Development Depts to assess the commercial potential of the projects • Submission of dossiers in CTD and eCTD format • Updating of dossiers in CTD and eCTD format • Submission of applications for variations (IA, IB, II) • Compliance activities (in collaboration with QA, QC departments) • Submission of applications for renewals • SPC and PL update~ Pharmacovigilance activities, like: • Preparation of pharmacovigilance reports (PSUR, signal detection); • Case import

Torino, Italia

• Medications preparation and dispensation by interpreting prescriptions and physician orders• Counseling patients on drug therapies• Preparation of galenic products with laboratory management• Contact with suppliers, sales agents and sales representatives

• Medications preparation and dispensation by interpreting prescriptions and physician orders• Counseling patients on drug therapies• Preparation of galenic products with laboratory management• Contact with suppliers, sales agents and sales representatives

Post Graduate Master In Pharmaceutical Technologies And Regulatory Affairs, 110 E Lode

Theoretical and practical knowledge of: Community Code (CC), Marketing Authorization (MA) procedures, Regulatory Agencies, MA Dossier.

Esame Di Stato Per L'Abilitazione All'Esercizio Della Professione Di Farmacista

Chimica E Tecnologia Farmaceutiche, Farmacia, 105

Argomenti trattati: Tecnologia, Socioeconomia e Legislazione Farmaceutica, Chimica organica, Chimica inorganica, Chimica Farmaceutica e.

Diploma, Scientifico Tecnologico, 85/100