Understanding Drug Master File (DMF): application of ICH Quality guidelines in API development

Struttura del corso

9:00 – 13:00

Programma:

• La struttura del Drug Master File
• Le linee guida ICH per la sua preparazione: stato attuale e prospettive future
• Focus su USA: documenti necessari al deposito ed alla manutenzione del DMF
• Focus su Europa documenti necessari al deposito ed alla manutenzione del DMF
• Focus su Giappone: documenti necessari al deposito ed alla manutenzione del DMF ed il ruolo dell’In-Country Caretaker
• Come applicare per un Certificate of Suitability in EDQM
• Come usare un CEP nel mondo
• Sistemi regolatori a confronto: le peculiarità del ciclo di vita del DMF in Cina e Brasile
• Q&A Session

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 in**@ph*******************.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 in**@ph*******************.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.