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Registered office: via Nomentana, 445 - 00162 Roma c\o UniOne Consulting. Fiscal Code: 975020505802

ASSOMONITOR is the Italian Society of Clinical Monitors that collects and represents both freelancer and employed CRA’s (Clinical Research Associate), working in pharmaceutical companies and CROs (Contract Research Organizations).

Assomonitor guarantees the highest and common professional  standard of CRA’s, with respect to the general requirements of quality of each subject involved, with various qualifications, in the field of Clinical Research and every kind of effort will be invest to achieve legislative and fiscal classification of Italian Clinical Monitors.

The Association promotes free of payment trainings on this website, in compliance with Ministerial Decree of 15 November 2011, “Definition of the minimum requirements which Contract Research Organisations (CRO) shall satisfy in order to work within clinical trials on medicinal products”, and other services, free of payment too, only reserved for the associates of Assomonitor.

Assomonitor guarantees the validity of training certificates provided by the Association to its own affiliates, enabling CRO and Pharmaceutical Companies to verify their actual achievement for the purposes of DM 15 Nov 2011.

 

News

(click on titles for links)

National Assembly Assomonitor 09/05/2020 The assembly of members of assomonitor is convened for 12 and 13 June 2020

EMA Guidance on the management of clinical trials during COVID 19 28/04/2020 Published version 3 of Guidance on the management of clinical trials during COVID 19

AIFA communication (update of AIFA communication published on 12 march 2020) 07/04/2020 AIFA communication (update of AIFA communication published on 12 march 2020) on management of clinical trials during COVID 19 emergency

EMA guidance on the management of Clinical Trials during the COVID 19 (Coronavirus) 27/03/2020 Guidance on the management of Clinical Trials during the COVID 19 (Coronavirus) pandemic Version 2 (27/03/2020)

AIFA Communication in order to clinical studies management in Italy during COVID-19 12/03/2020 AIFA Communication in order to clinical studies management in Italy during COVID-19

PER DIVENTARE CRA...

  • possesso del diploma di laurea in discipline sanitarie/
    scientifiche attinenti alle tematiche da svolgere;

  • almeno 40 ore di formazione teorica nei settori della GCP, della normativa, della metodologia sperimentale, della farmacovigilanza, della GMP, dei sistemi di qualità, dei compiti del Clinical Monitor

  •  almeno 20 giorni di attività di monitoraggio in affiancamento a monitor esperti, di cui 10 svolti presso Centri sperimentali (entro 12 mesi prima dell’inizio dell’attività);

  • Oppure Master Universitario (entro 36 mesi prima dell’inizio dell’attività) oppure 4 mesi di attività nel Settore della sperimentazione clinica (entro 12 mesi prima dell’inizio dell’attività) oppure 40 giorni totali, di cui 20 svolti presso Centri sperimentali (entro 12 mesi prima dell’inizio dell’attività).

 
 
 

 

SE TI ASSOCI AD ASSOMONITOR

  • Training online (certificato rilasciato immediatamente e archivio dei training frequentati)

  • Newsletters

  • Accesso alle offerte di lavoro (e loro ricezione sulle caselle di posta dei soci)

  • Casella di posta con dominio @assomonitor.org

  • Casella di posta certificata con dominio @pec.assomonitor.org

  • Consultazione della lista dei soci

  • Download delle ricevute di pagamento

 

 

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