Menu Back toEMA EudraVigilance & Signal Management Virtual Information Day

EMA EudraVigilance & Signal Management Virtual Information Day

This virtual live Information Day will focus on the ISO 27953-2:2011 as well as ISO 11239:2012 standards which will become applicable as of 30 June 2022 for all reporting to EudraVigilance. It will also highlight the impact on EV and Signal Management with regard to COVID-19 and provides an update on the revision of the existing ICH-E2D.


Overview

Based on a Pharmacovigilance Risk Assessment Committee (PRAC) recommendation, the EMA Management Board confirmed and announced the mandatory use of the ISO Individual Case Safety Report (ICSR) standard (ISO 27953-2:2011) based on the ICH E2B(R3) modalities as of 30 June 2022 for all reporting to EudraVigilance. Furthermore, the ISO terminology on pharmaceutical dose forms and routes of administration, (ISO 11239:2012), will also become mandatory at the same time.

This information day will highlight the necessary technical adaptation and implications for the use of the EDQM (European Directorate for the Quality of Medicines & HealthCare) terms to implement the pharmaceutical dose forms and routes of administration.

The COVID-19 pandemic and the authorisation of the vaccines against COVID-19 have a major impact on EudraVigilance and the database plays a crucial role on the signal detection and management activities for the vaccines. The impact on the database and the network together with the main signal management activities and achievements will be also outlined. 

An update of the existing ICH E2D (Post Approval Safety Data Management: Definitions and Standard for Expedited Reporting) guideline is proposed to clarify the management of post-approval safety information from new or increasingly used data sources. The revision of the E2D guideline will be an important opportunity to improve the generation of information related to safety and the problem statement together with the objectives will be explored.

Other aspects and milestones in the EudraVigilance operational workplan will be summarised.

Featured topics

  • Mandatory use of ICH-E2B(R3). Implementation of ISO Individual Case Safety Report standard and ISO terminology on pharmaceutical dose forms and routes of administration.
  • COVID-19 vaccines. Impact on EudraVigilance and Signal Management.
  • Revision of ICH- E2D. Problem statement and objectives
  • EudraVigilance Work Plan – Key milestones.  

Who should attend?

  • Qualified Persons Responsible for Pharmacovigilance (QPPVs)
  • Sponsors of Clinical Trials
  • Individuals involved in clinical development, information management, safety databases
  • Pharmacovigilance Information Technology Professionals

Program Committee

  • Paolo  Alcini
    Paolo Alcini Head of Healthcare Data
    European Medicines Agency, Netherlands
  • Georgy  Genov, MD
    Georgy Genov, MD Head of Pharmacovigilance Office, Quality and Safety of Medicines Department
    European Medicines Agency, Netherlands
  • Rodrigo  Postigo
    Rodrigo Postigo Scientific Administrator
    European Medicines Agency, Netherlands
  • Gilles  Touraille, PharmD, PhD
    Gilles Touraille, PharmD, PhD Scientific Administrator
    European Medicines Agency, Netherlands
  • Anja  Van Haren, MSc
    Anja Van Haren, MSc EudraVigilance Coordinator
    Medicines Evaluation Board (MEB), Netherlands
Load More

Contact us

Questions to the Agenda

Send Email
+41 61 225 51 51


Registration Questions?

Send Email
+41 61 225 51 51