Percorso formativo in Market Access Farmaceutico – Modulo 2: I dati a supporto dell’accesso – La loro importanza e come li usiamo nel dossier p&r

Struttura del corso
MODULO 2: I DATI A SUPPORTO DELL’ACCESSO – LA LORO IMPORTANZA E COME LI USIAMO NEL DOSSIER p&r
19 Ottobre 2023
09:30 – 17:00 ORARIO SESSIONE

Programma

09:30  Introduzione alla giornata
Sabrina Baldanzi | Market Access & Government Affairs Director, Grünenthal Italia

09:45  Real World Evidence
Il ruolo dei dati di real world nel processo di accesso al mercato
Lara Pippo | Direttore Market Access & Government Affairs, CSL Behring Italia

10:45  Coffee break

11:10 Burden of disease/Cost of Illness
– I costi sanitari
– I costi societari
– Il bisogno insoddisfatto
Lara Pippo

11:45 Modelli e non solo
– Analisi di impatto sul budget
– Analisi di costo-efficacia
– I dati e le fonti
Lara Pippo

12:45 Q&A Session
Sabrina Baldanzi

13:00 Pausa pranzo

14:00 La nuova normativa di P&R
– Cosa è cambiato nel nuovo decreto prezzi
– Implicazioni e rischi
Sabrina Baldanzi

14:30 La struttura del dossier
– Overview della struttura del dossier
– Focus sulle novità documentali introdotte
– Struttura del dossier in caso di procedure semplificate
Raffaella Pandini | Regulatory Affairs Director Pharma D&S

15:30 E-dossier
– Il “nuovo” portale
– Finalità del portale
Esperienze sulla compilazione dell’e-dossier
Raffaella Pandini

16:30 Q&A Session

17:00  Chiusura giornata

The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.

For online trainings the access link will be sent 2-3 days before the start of the training.

5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

Cancellation terms

In order to cancel enrolment to an event, please email info@pharmaeducationcenter.it within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting info@pharmaeducationcenter.it. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.