Service Centre category(ies)
Clinical Research / Clinical Trials
ICT & Electronics / Bioinformatics / Biomodelling / Biostatistics
Description of the Service Centre
Pharmacovigilance plays an essential role in the protection of public health, especially in assessing the risks and benefits of medicinal products. The department works in continuous cooperation with its partners, whether they are small businesses or multinational companies.
Service Centre web address
http://www.eurotrials.com/index.php?m=18&idioma=2
Contact person's name
Carla Lopes
Contact person's e-mail
carla.lopes@eurotrials.com
Contact person's telephone
(+351) 21 382 54 40
Service
Pharmacovigilance Local Point of Contact
Available for external use?
Yes
Comments
Receiving / Processing adverse events/ reactions informations | Availability 24h / 7 days
Service
Pharmacovigilance Consulting
Available for external use?
Yes
Comments
Preparation of written pharmacovigilance procedures (SOPs) | Pharmacovigilance audits | Preparation of PSURs | External Pharmacovigilance training courses (e.g Sales representatives) | Risk Management Plans/ Educational Materials | MedDRA Coding | Literat
Service
Implementation of Pharmacovigilance systems according to the European Reg
Available for external use?
Yes
Comments
In collaboration with our PV partner
Service
Applicable SOPs and Pharmacovigilance System Master File
Available for external use?
Yes
Comments
In collaboration with our PV partner
Service
European Qualified Person for Pharmacovigilance - EUQPPV
Available for external use?
Yes
Comments
In collaboration with our PV partner
Service
Product Knowledge and Safety Diagnosis
Available for external use?
Yes
Comments
In collaboration with our PV partner
Service
Risk Management Plan
Available for external use?
Yes
Comments
In collaboration with our PV partner
Service
Handling of SAE (Serious adverse events)
Available for external use?
Yes
Comments
In collaboration with our PV partner
Service
Case Reporting to EMA and NCA (electronic transmission)
Available for external use?
Yes
Comments
In collaboration with our PV partner
Service
Safety database: (CFR part 11 compliance)
Available for external use?
Yes
Comments
In collaboration with our PV partner
Service
Eudravigilance
Available for external use?
Yes
Comments
In collaboration with our PV partner
Service
Signal detection activity
Available for external use?
Yes
Comments
In collaboration with our PV partner
Service
Interface with Quality Assurance
Available for external use?
Yes
Comments
In collaboration with our PV partner
