Who can use EudraVigilance?
Qualified person for pharmacovigilance, regulatory contact point and responsible person for Eudravigilance. MAHs are legally required to have a qualified person for pharmacovigilance (QPPV) based in the European Union (EU) in place at all times, in line with Directive 2001/83/EC Article 104(3)(a).
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 the 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 Xevmpd submission?
XEVMPD is a database designed to support the collection, reporting, coding and evaluation of data on medicines in a standardised and structured way.
How do you become a QPPV?
The minimum qualifications, training and experience required by a QPPV is a 4 year university degree, which must be within the sphere of pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology or biology.
What is Icsr processing system in EU?
‘ICSR’ refers to an Individual Case Safety Reports which must be compiled for each instance of a suspected or confirmed adverse event and submission of such report to the Competent Authority (CA) of the Member State.
How does EudraVigilance work?
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.
Is the UK in EudraVigilance?
At present, there is a significant contribution from the UK for EudraVigilance, through instantaneous reports generated by patients, life sciences specialists and pharma businesses.
What is the difference between Xevmpd and IDMP?
The IDMP Browser helps make your coding projects a success. The standard route of administration controlled vocabulary is populated and maintained by EMA. The XEVMPD value is the EDQM standard term value whilst the unique identifiers (i.e. EV Codes) are randomly and automatically assigned by the EV system upon request.
Where can I find summary of product characteristics?
Summaries of product characteristics form the basis of information for healthcare professionals on how to use the medicine safely and effectively. Abbreviated as SmPC. More information can be found under ‘Product-information requirements’ and ‘Guideline on summary of product characteristics’.
How do I get a UK PSMF number?
A UK PSMF number can be requested via the MHRA Submissions Portal. You should follow the online instructions for requesting a UK PSMF number and you should receive the number by email immediately upon completion of the form. The address from which the PSMF can be electronically accessed must be in the UK.
What is Article 57 (XEVMPD)?
Article 57 (xEVMPD). Managing the details that keep you compliant. MAHs and Applicants for medicines in the EU must submit information on authorized medicines to the eXtended EudraVigilance Medicinal Product Dictionary ( xEVMPD ), also known as the Article 57 database, and keep this information up-to-date.
What is EudraVigilance xevprm?
Marketing-authorisation holders were initially required to submit information on medicinal products for human use to the European Medicines Agency (EMA) using the electronic format referred to as Article 57 format or eXtended EudraVigilance Product Report Message (XEVPRM) format by 2 July 2012.
What is Article 57 of the EMA?
Data submission on authorised medicines (Article 57) All holders of marketing authorisations for medicines in the European Union (EU) and the European Economic Area (EEA) must submit information to the European Medicines Agency (EMA) on authorised medicines and keep this information up-to-date. This is a legally binding requirement from
What training courses does the EudraVigilance training programme offer?
The EudraVigilance training programme offers the following training courses: Introduction to Pharmacovigilance and Electronic Transmission of Individual Case Safety Reports (ICSR) to Eudravigilance The training courses dates are accessible here.