Aggiornamenti EU sugli IMPs – Investigational Medicinal Products

Struttura del corso

09:00 – 13:00 SESSIONE MATTINA
14:00 – 17:00 SESSIONE POMERIGGIO

Programma

• Regolamento (UE) n. 536/2014 del 08 Dicembre 2017: obiettivi e punti chiave
• Direttiva 2003/94/CE, che stabiliva congiuntamente i principi e le linee guida delle GMP sia per i medicinali commerciali che per gli IMPs, è stata sostituita
• DIRETTIVA (UE) 2017/1572 DELLA COMMISSIONE del 15 Settembre 2017: contesto normativo ed interpretazione
• REGOLAMENTO DELEGATO (UE) 2017/1569 DELLA COMMISSIONE del 23 Maggio 2017: contesto normativo ed interpretazione
• EU GMP guideline per IMPs PER USO UMANO versus Annex 13
• Nuova Linea guida sulle responsabilità dello sponsor in merito alla gestione e alla spedizione di medicinali sperimentali per uso umano in conformità con le GCP e le GMP emessa il 16 dicembre 2022.
• Ruoli di QP, QA, Clinical Supply Manager o auditor in questo nuovo scenario
• Aree di interfaccia tra il manufacturer e lo sponsor: accordi contrattuali richiesti
• Cenni sulla normativa IMP per mercato US

Personale coinvolto nella gestione degli IMPs: Produzione, Quality, Sterility Assurance, Regulatory Affairs, Qualified Person, Clinical Supply.

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.