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Service Centre

Pharmacovigilance

Eurotrials, Consultores Científicos, S.A.

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

Services

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

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