How do I request access to EudraLink?
If you require an EudraLink account, you can request it via the EMA Service Desk after you have created an EMA account.
What is EudraLink?
• EudraLink is a Secure File Transfer System. • EudraLink has been designed to enable users to send large amounts. of information securely over the Internet. • EudraLink is available to users from the EMA, National Competent. Authorities, Pharmaceutical Companies, members of Working Parties /
What is Prime EMA?
PRIME is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need.
What is EudraVigilance database?
EudraVigilance is the pharmacovigilance database to manage the collection and analysis of suspected adverse reactions to medicines authorised in the European Economic Area. EudraVigilance first operated in December 2001, with access to the database being governed by the EudraVigilance access policy.
What is eRMR in PharmacoVigilance?
eRMR = electronic Reaction Report.
How does EudraVigilance work?
What is EEA in pharmacovigilance?
EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA).
What is Evdas?
EudraVigilance data analysis system (EVDAS) The EudraVigilance data analysis system (EVDAS) supports EU pharmacovigilance safety monitoring activities with the main focus on signal detection and evaluation of ICSRs. EVDAS includes a measure of disproportionality, which is the reporting odds ratio (ROR).
Who runs EudraVigilance?
The European Medicines Agency (EMA)
The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network. The European EudraVigilance system deals with the: Electronic exchange of Individual Case Safety Reports (ICSR, based on the ICH E2B specifications):
What is EMA EudraVigilance?
EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA).
What is EudraVigilance Gateway?
EudraVigilance is a system for monitoring the safety of medicines. Its components facilitate electronic reporting of suspected adverse reactions related to medicines and the effective analysis of data. This enables the early detection of potential safety issues.
What is ime in pharmacovigilance?
Medical Event Terms (IME) list. This IME list aims to facilitate the classification of suspected adverse. reactions as well as aggregated data analysis and case assessment in the frame of the day-to-day. pharmacovigilance activities of stakeholders in the European Union.
What is EudraVigilance in pharmacovigilance?
What is the IME list?
The IME list is based on PT level coding in MedDRA. This level is mostly used for database search and data analysis.
What is ICH E2A?
ICH TOPIC E2A. Page 1. INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL. REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN. USE.
What is DME in pharmacovigilance?
Designated medical event (DME) DMEs are serious and rare medical events that are often causally associated with drugs across multiple pharmacological/therapeutic classes. DMEs are serious, rare and often causally associated with drugs.
What is the difference between ADR and AE?
An adverse event (AE) is any negative medical occurrence that is associated with the use of a medication or a medical error. An AE can be life-threatening. An ADR differs from an AE in that an ADR is associated with a causational relationship between the medication and the injury.
How do I request an eudralink account?
EUDRASAFE ACCOUNT REQUEST FORM Eudralink Account Request Form PERSONAL INFORMATION Gender: Type here you Gender (F1 for more information) Title: Type here your Title (F1 for more information) First Name: Type here your First Name (F1 for more information) Last Name: Type here your Last Name (F1 for more information)
Who is the author of eudrasafe account request form?
EUDRASAFE ACCOUNT REQUEST FORM Author Valerio Pagliari Last modified by emea Created Date 10/22/2010 1:17:00 PM Company JRC Other titles EUDRASAFE ACCOUNT REQUEST FORM
Why has my eudralink service been suspended?
I am aware that the Eudralink service could be suspended for maintenance purposes after e-mail notification to the end-users, or it could be suspended for un-predictable causes due to system or network failures. I certify that I will use Eudralink services for Pharmaceutical Regulatory purposes only.