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ONLINE TRAINING: La gestione del Case Processing in Farmacovigilanza

Raccolta, gestione e trasmissione delle segnalazioni di sospette reazioni avverse

Date

02 and 07 July 2020

Location

Online

Language

Italian

ONLINE TRAINING: La gestione del Case Processing in Farmacovigilanza

Il Modulo VI delle GVP definisce che le autorità competenti e i titolari di AIC devono adottare tutte le misure appropriate per raccogliere e collezionare le segnalazioni di sospette reazioni avverse associate a medicinali per uso umano.
La gestione delle segnalazioni di sospette reazioni avverse deve essere tale da garantire che i report raccolti siano accurati, coerenti, verificabili e il più completi possibili per la loro valutazione clinica.
L’obiettivo di questo corso è quello di far comprendere l’importanza di una corretta identificazione e elaborazione delle segnalazioni (case processing). Il partecipante potrà acquisire le nozioni e gli strumenti necessari per gestire, in maniera autonoma, le segnalazioni di sospette reazioni avverse.

MODULO 1 - 02 luglio 2020; h. 10:00 - 12:00

• Good pharmacovigilance practices – modulo VI;

• Tipologie e fonti di segnalazione;

• Codifiche MedDRA e dei prodotti medicinali nel case processing.


MODULO 2 - 07 luglio 2020; h. 10:00 - 12:00

• Gestione delle segnalazioni (validazione, ricerca duplicati, triage, data entry, quality control, medical review, reporting e chiusura);

• Safety Reports;

• Modalità di trasmissione elettronica di ICSRs a Eudravigilance.

 

Lingua del corso

Il corso si terrà in italiano.

Nicola Sisti
Nicola Sisti Drug Safety Manager – seQure Life Sciences
Laurea magistrale in Farmacia presso l’Università degli Studi di Perugia. Prosegue la formazione post-laurea con il Master Universitario full time di II° livello in Healthcare Management presso SDA Bocconi – Milano dove si specializza in management sanitario. Varie esperienze in Italia e all’estero presso aziende farmaceutiche-biofarmaceutiche-biomedicali dove ha lavorato in diverse business units. Da Novembre 2015, Pharmacovigilance officer presso PM Clinical LTD poi diventata da luglio 2017 seQure Life Sciences S.r.l., in cui ricopre il ruolo di Drug Safety Manager, responsabile delle attività di case processing post marketing e studi clinici, analisi ed inserimento ICSRs in Eudravigilance, monitoraggio della letteratura medico-scientifica, deputy QPPV, produzione di KPIs, stesura di SOP-WI e supporto alla stesura di PSUR-RMP-ACO. Ha ricoperto il ruolo di Case management Coordinator, coordinando le operations del team di case processing tra diversi progetti. Attualmente ricopre il ruolo di Drug Safety Manager con funzioni di Trainer/Project Manager, con responsabilità rispettivamente di formazione delle figure junior- configurazione di Safety database e di controllo, coordinamento e supervisione delle attività di case processing per specifici progetti.

Pharmacovigilance Officer, Pharmacovigilance Operations Trainee, Pharmacovigilance Operations Specialist, Safety Data Manager, Drug Safety Manager.


Esperienza del partecipante:

Conoscenza base di Farmacovigilanza.

Online Training

Slides, examples, Q&A.

ONLINE TRAINING

This online training is divided in 2 modules:


- Module 1 |  02 July 2020 from 10:00 am to 12:00 pm

- Module 2 | 07 July 2020 from 10:00 am to 12:00 pm


Some days before the online training you will receive all details about the connection.


The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Certificate of attendance

Early Bird: € 390,00* (until 18 June 2020)

Ordinary: € 465,00*

Freelance - Academy - Public Administration**: € 234,00*


* for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance - Academy - Public Administration fee


The fee includes: Access to the online training, teaching materials in pdf format provided post-webinar, organizational office support, certificate of attendance.

Register now

Course Price

465.00 €

Early Bird

Thursday, June 18, 2020

390.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

2 modules (2 hours each)

Course Type

Limited number of participants

You will receive

Certificate of attendance

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

  • Conoscere le caratteristiche delle segnalazioni

  • Gestire le segnalazioni

  • Comprendere l’utilizzo dei safety reports

Participants' Feedbacks

Teacher was very clear  and outstanding  knowledge of the contents 

Discussion of the topics covered by the course, not only from the Pharmacovigilance point of view, but considering the interactions with other functions / other company departments

Teachers very expert and very good in comunication

Teacher very expert on the subject, available  with the participants, exhaustive in the explanations

The course gave me clear examples

Speakers very capable in deepening vast and complex topics

I was put at ease during the course and the discussions

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ONLINE TRAINING: La gestione del Case Processing in Farmacovigilanza

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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.
Via Roma, 20 – 24022 Alzano Lombardo (Bergamo)
VAT: IT03633040161
BANCO BPM – Filiale di Carobbio degli Angeli
IBAN: IT81 F 05034 53960 000000003450
SWIFT Code: BAPPIT21AY5

Confirmation of event admission will be given on receipt of payment. Invoice will be sent following receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants or registrations of roles that are not included in the target of the event.

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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In accordance with the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, we inform you that EasyB S.r.l. (with headquarter in Via Roma 20, Alzano Lombardo, Bergamo, Italy, VAT number IT03633040161) will use your personal data voluntarily provided by you only with the consent and in compliance with the principles dictated by the European Regulations on the protection of personal data for sending newsletters, for marketing purposes (sending advertising material, market research and commercial communication) and for communication purposes to third parties (lecturers, scientific board, speakers, conferences’ sponsor), also for marketing goals. You can read the complete information, including your rights and the procedures for the exercise of the same, following this link.