Regulatory Intelligence in Pharmacovigilance

"As part of our ongoing regulatory intelligence activities,
QVigilance team actively monitors websites, newsletters,
and RSS feeds of regulatory authorities and international
standards organisations; as well as reviewing
relevant articles and blogs"

Esther Poole
PHARMACOVIGILANCE SPECIALIST

Ongoing Monitoring Services

QVigilance continuously monitors regulatory information from local, regional and global authorities and organisations for pharmacovigilance-related regulatory intelligence to ensure that we and our customers are always up to speed and thereby maintain compliance with the latest regulatory requirements and guidelines for both investigational and authorised products.

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What you need to know about the ...

25 Sep, 2019

The Good Pharmacovigilance Practice (GVP) Guideline 'Product- or Population-Specific Considerations IV: Paediatric Population' came into effect on 08 November 2018.  It forms part of the European Medicines Agency (EMA) ...

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QPPV and PSMF requirements in case ...

17 Sep, 2019

On 07 August 2019, the Medicines and Healthcare products Regulatory Agency (MHRA) updated the guidance, previously published on 12 March 2019, on the qualified person responsible for pharmacovigilance (QPPV) and ...

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A Guide to the US FDA Safety ...

31 Jul, 2019

To ensure a smooth transition from the pre-authorisation to the post-authorisation phase of the life-cycle of a medicinal product, it is the responsibility of the applicant to have in place a robust Pharmacovigilance ...

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