ICH Q3D: Fondamenti, aspetti pratici e gestione lifecycle

Struttura del corso

9:00 – 13:00 ORARIO SESSIONE

Programma:

• Introduzione e contesto normativo
  • Posizionamento della ICH Q3D nel contesto regolatorio globale (EMA, FDA, ICH)
  • Evoluzione normativa: dal test dei metalli pesanti (USP <231>) a un approccio risk-based
• Fondamenti della linea guida ICH Q3D: obiettivi, struttura e concetti essenziali
  • Ambito di applicazione
  • Classificazione delle EIs: Classe 1, 2A, 2B e 3, Other elements
  • PDE (Permitted Daily Exposure): definizione e vie di somministrazione
  • PDE vs CTCL (cutaneous and transcutaneous concentration limit)
  • Calcolo dei limiti per la compliance: Option 1, 2a, 2b e 3
• Risk Assessment e Strategie di controllo
  • ICH Q3D ed integrazione con il Quality Risk Management – ICH Q9(R1)
  • Identificazione delle potenziali fonti di impurezze nel prodotto finito
  • Valutazione e controllo del rischio
  • Approcci per la gestione del rischio: approccio per componenti vs approccio per prodotto finito
  • Testing analitico: tecniche e riferimenti
• Risk Review & Lifecycle management
  • Gestione dei cambiamenti ed impatti regolatori: quando aggiornare la valutazione del rischio
  • Come mantenere la conformità nel tempo
• Casi pratici e implementazione in azienda
  • Caso studio: come sviluppare un Risk Assessment
  • Caso studio: come revisionare un Risk Assessment
  • Errori comuni da evitare
• Conclusioni
• Q&A

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.