The EudraVigilance Information Day will provide a forum for marketing authorisation holders and sponsors of clinical trials to gain a better understanding of the key activities of the EudraVigilance Expert Working Group in line with their work programme for 2009 (see http://eudravigilance.emea.europa.eu). The main areas that will be addressed are as follows:
鈥� Examples of implementation aspects related to electronic reporting of ICSRs
鈥� Key pharmacovigilance activities in some of the EU Member States
鈥� Practical implementation questions raised by stakeholders with main focus on:
- Electronic reporting of ICSRs and EudraVigilance including SUSARs in clinical trials
- Pharmacovigiliance and risk management activities
鈥� Implementation of the EudraVigilance Access Policy
Update on ICH activities in collaboration with Standard Development Organisations (SDOs) with main focus on:
- The revision of the ICH E2B(R2) guideline
- The development of the ICH M5 topic on Data Elements and Standards for Drug Dictionaries
- Testing activities related to the development of the new standards
Other topics will be addressed depending on the questions received through a quick survey based on a questionnaire sent by the DIA to the registrants prior to the Information Day. Panel discussions will provide the opportunity for extensive Q&As with the speakers and Programme Committee members.
鈥� Examples of implementation aspects related to electronic reporting of ICSRs
鈥� Key pharmacovigilance activities in some of the EU Member States
鈥� Practical implementation questions raised by stakeholders with main focus on:
- Electronic reporting of ICSRs and EudraVigilance including SUSARs in clinical trials
- Pharmacovigiliance and risk management activities
鈥� Implementation of the EudraVigilance Access Policy
Update on ICH activities in collaboration with Standard Development Organisations (SDOs) with main focus on:
- The revision of the ICH E2B(R2) guideline
- The development of the ICH M5 topic on Data Elements and Standards for Drug Dictionaries
- Testing activities related to the development of the new standards
Other topics will be addressed depending on the questions received through a quick survey based on a questionnaire sent by the DIA to the registrants prior to the Information Day. Panel discussions will provide the opportunity for extensive Q&As with the speakers and Programme Committee members.
