Pharmacovigilance (PV) ensures safe and effective use of products throughout their lifecycle. Many sponsors struggle with…
Pharmacovigilance Blog
New PV practice guidance on Pregnancy Prevention Programmes by EMA
European Medicines Agency releases new draft good pharmacovigilance practice guidance on pregnancy prevention programmes…
What you need to know about the GVP Paediatric Guideline
The Good Pharmacovigilance Practice (GVP) Guideline ‘Product- or Population-Specific Considerations IV: Paediatric…
A Guide to the US FDA Safety Requirements for Pharmacovigilance
To ensure a smooth transition from the pre-authorisation to the post-authorisation phase of the life-cycle of a medicinal…
Brexit and Pharmacovigilance considerations: UK Draft contingency legislation released
The UK government has released draft legislation amending the regulation of authorised Medicinal Products, Medical Devices…
Pharmacovigilance in the European Union (EU): Preparing for Authorisation of your Medicinal Product
To ensure a smooth transition from the pre-authorisation to the post-authorisation phase of the life-cycle of a medicinal…