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Medical Affairs Consulting - Home

Medical Affairs Consulting: a consultancy agency providing support on Pharmacovigilance, Drug Safety, Periodic Safety Update Reports, Risk Management Plan, Clinical Summary, Clinical Overview, Integrated Clinical Report, Project Management

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Medical Affairs Consulting - Home | med-af-consulting.it Reviews

https://med-af-consulting.it

Medical Affairs Consulting: a consultancy agency providing support on Pharmacovigilance, Drug Safety, Periodic Safety Update Reports, Risk Management Plan, Clinical Summary, Clinical Overview, Integrated Clinical Report, Project Management

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1

Medical Affairs Consulting - Project Management

http://www.med-af-consulting.it/home/project-management

Pharmacovigilance and Drug Safety. Support to Management for document preparation. Support right from the very first phases of:. Implementation of the protocol. Support in site selection.

2

Medical Affairs Consulting - Pharmacovigilance & Drug Safety

http://www.med-af-consulting.it/home/pharmacovigilance-and-drug-safety

Pharmacovigilance and Drug Safety. Support to Management for document preparation. Pharmacovigilance and Drug Safety. Pharmacovigilance and Drug Safety. Organization and management of the Pharmacovigilance System. Qualified Person for PV (QPPV). Contact Point for Competent Authorities. Handling of Eudravigilance Data Base for ICSR and XEVMPD. Management and notification to Competent Authorities /EMA of:. Reports arising from clinical studies (SAE / SUSARs),. Reports arising from Literature.

3

Medical Affairs Consulting - Cosa cambia con la nuova Normativa Europea di Farmacovigilanza

http://www.med-af-consulting.it/home/blog/normativa-europea-di-farmacovigilanza

Pharmacovigilance and Drug Safety. Support to Management for document preparation. Cosa cambia con la nuova Normativa Europea di Farmacovigilanza. Cosa cambia con la nuova Normativa Europea di Farmacovigilanza. 19112012 - Cosa cambia con la nuova Normativa Europea di Farmacovigilanza. Stefano Franchini, M.D. - Titolare di Medical Affairs Consulting. Per comprendere questi profondi mutamenti è possibile far riferimento all’introduzione delle. Il Sistema di Farmacovigilanza diventa sempre più una funzione ...

4

Medical Affairs Consulting - Blog

http://www.med-af-consulting.it/home/blog

Pharmacovigilance and Drug Safety. Support to Management for document preparation. 19112012 - Cosa cambia con la nuova Normativa Europea di Farmacovigilanza. Siamo di fronte ad uno dei cambiamenti più importanti nel campo della Farmacovigilanza nell’ambito dell’Unione Europea e delle sue implicazioni a livello globale. La nuova normativa europea ed il suo .

5

Medical Affairs Consulting - Support to Management for document preparation

http://www.med-af-consulting.it/home/support-to-management

Pharmacovigilance and Drug Safety. Support to Management for document preparation. Support to Management for document preparation. Support to Management for document preparation. Support in drafting of:. Investigational Medicinal Product Dossier. Section 2.5 and Section 2.7 (Clinical Summary and Clinical Overview) of the Common Technical Document (CTD).

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Medical Affairs Consulting - Home

Pharmacovigilance and Drug Safety. Support to Management for document preparation. A consultancy agency with a long-standing professional experience, Medical Affairs Consulting has been providing top quality services to the pharmaceutical industry for many years. In particular, we focus on providing support to activities typically carried out by Medical Departments / R&D / Clinical Operations. Our expertise encompasses the following activities and services:. Pharmacovigilance and Drug Safety.

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