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WEBINAR: Clinical Study Report e Clinical Investigation Report

Un’introduzione sulle similitudini e differenze tra CSR e CIR

Date

01 Aprile 2020 ore 11.30

Location

Webinar

Language

Italiano

WEBINAR: Clinical Study Report e Clinical Investigation Report

I Clinical Study Reports (CSR) sono i documenti critici da preparare al termine di ogni studio clinico sui prodotti farmacologici, siano essi sperimentali o interventistici. Anche i risultati di qualsiasi studio clinico sui dispositivi medici devono essere descritti in modo standardizzato nei cosiddetti Clinical Invetigation Reports (CIR).

CSRs e CIRs si stanno trasformando da documenti ad esclusivo uso regolatorio, in documenti che devono essere pubblicati. Sia CSR che CIR hanno moltissimi punti in comune ed alcune differenze; di conseguenza, l'approccio per preparare ciascuno di questi documenti deve essere ben compreso in modo da poter utilizzare l’esperienza maturata per la preparazione di nuovi documenti.

  • Introduzione
  • Il ruolo del medical writer
  • La struttura di CSR vs CIR
  • CSR e CIR: differenze e uguaglianze
  • Q&A
  • Chiusura

Lingua del webinar: italiano
Andrea Rossi
Andrea Rossi Freelance International Scientific Communicator

Andrea has a degree in Biology from Florence University. After a brief spell at the University, he started working in the Italian Affiliate of Eli Lilly as a Clinical Research Associate. In the years that followed he was responsible for Statistics, Health Outcomes and Medical Information. Andrea has been working as Medical Writer since 2003 beginning in Italy and, then, becoming responsible of worldwide scientific affairs in a biosimilar company based in Switzerland.
He is author of more than 350 disclosures and acknowledged for his contribution in several others. From 2007 to 2009 he was on the coordination board of BIAS (Biometristi Italiani Associati) and has been a European Medical Writers Association (EMWA) member since 2004. Andrea acts as trainer for statistics and medical writing in some Italian schools for specialisation in medicine and has been a speaker at national and international conferences.
Andrea leads workshops for and is past-president and ambassador of EMWA.

Il webinar è rivolto a tutti coloro che operano in aziende farmaceutiche, dispositiivi medici e CROs che sono coinvolti nella stesura o nella revisione di Clinical Study Report (CSR) e Clinical Invetigation Report (CIR).

Esperienza del partecipante

E’ importante conoscere le basi della ricerca clinica.

Webinar 

Webinar online 

Webinar online: 1 aprile 2020 ore 11.30

Tutti i dettagli utili per il collegamento verranno forniti dopo l'iscrizione

Brochure
Attestato di partecipazione

WEBINAR 

Ordinaria: € 120,00 + IVA

Freelance – Accademia – Pubbliche Amministrazioni: € 96,00 + IVA

La quota comprende: Partecipazione al webinar, materiale didattico e attestato di partecipazione che saranno inviati per e-mail post webinar.

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Course Price

120.00 €

Early Bird

Tuesday, March 31, 2020

120.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

1,15 hour

Course Type

Limited number of participants

You will receive

Certificate of attendance

At the end of the training, you will be able to

  • Comprendere gli insegnamenti di Omero sulla gestione della crisi

  • Distinguere i comportamenti proattivi da quelli reattivi

  • Acquisire linguaggio e metafore Omeriche per la gestione della crisi

Participants' Feedbacks

A lot of information, examples calculations helped for understanding

Very focused and pragmatic

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WEBINAR: Clinical Study Report e Clinical Investigation Report

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Terms & Conditions

Trainings
The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee.
The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Conferences
The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance. For further information please contact:  e-mail: events@LSAcademy.com  telephone: +39 (0)35.515684

Webinars
The fee includes: tuition, teaching materials, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee. For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Common Terms & Conditions

Terms of payment
Payment should be made online (by credit card) or by bank transfer, at the time of registration (only for Italian companies: + 22% VAT) to EasyB s.r.l by bank transfer or by credit card. Bank transfer payable to:

EasyB S.r.l.
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Cancellation
Please note that refunds (50% refund of the registration fee) will only be given if cancellation is received at least four weeks before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed for free and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event, to change its performance from residential to webinar/online. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, hostilities, epidemics, pandemics, and / or authorities’restrictions (so-called factum principis).

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