IRIS for Good Pharmacovigilance practice (GVP) inspections training session for industry users

• Date:
  Wednesday, 07 September 2022 , 10:00 - 11:30 Amsterdam time (CEST)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

Update: EMA has rescheduled this event from 8 September 2022 to 7 September 2022.

Good Pharmacovigilance practice (GVP) inspections are conducted to ensure that requirements for monitoring the safety of medicines are met. The responsibility for carrying out the inspections rests with the national competent authorities.

The European Medicines Agency (EMA) coordinates GVP inspections requested by the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Medicinal Products for Veterinary Use (CVMP).

Following the go-live of IRIS for Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) inspections, EMA is onboarding GVP Inspections on the IRIS platform with an expected go-live in Q3 2022.

The benefits relevant to industry stakeholders include:

1. Efficiency gains
   • Harmonisation across different inspections types;
   • automation of notifications to Applicants/MAHs;
   • increased data quality through integration with other EMA systems, making use of already available SPOR (Substances, Products, Organisations and Referentials) master data.
2. Increased security, reducing the risk of unintentional disclosure of confidential information.
3. Streamlined and secured processes for information exchange.
4. Better knowledge management
   • Easier access to and retrieval of all inspections data in the context of Centralised Procedure available from one single platform, also providing users with search functionalities.

This webinar aims to explain the GVP Inspections business process in IRIS highlighting the changes and answer any potential questions from industry users.

Topics that will be addressed in this webinar include:

• IRIS overview
• IRIS access management
• GVP Inspections business process, including demo of the Industry Portal
• Guidance and support

Documents

Agenda - EMA IRIS industry training for GVP Inspections

Presentation - EMA IRIS industry training for GVP Inspections

Questions and answers - IRIS for Good Pharmacovigilance practice (GVP) inspections training session for industry users

Registration

• Registration open
• Video recording will be available

Video recording