QVigilance Blog & Regulatory Updates | QVigilance Team

• Pharmacovigilance Blog
• GVP

What you need to know about the GVP Paediatric Guideline

The Good Pharmacovigilance Practice (GVP) Guideline 'Product- or Population-Specific Considerations IV: Paediatric ...

25 Sep, 2019

• Pharmacovigilance Blog

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 ...

31 Jul, 2019

• Brexit News

MHRA e-Submission Update in preparation for Brexit

The Medicines and Healthcare products Regulatory Agency (MHRA) have released guidance on how to make regulatory ...

06 Mar, 2019

• Regulatory Intelligence

Health Canada: Discontinuation of Acknowledgement Letters for Regulatory Activities

On 30th Jan 2019, Health Canada issued a notice that effective from 01st April 2019, it will discontinue issuing ...

05 Mar, 2019

• Pharmacovigilance Blog
• Brexit News

Brexit and Pharmacovigilance considerations: UK Draft contingency legislation released

The UK government has released draft legislation amending the regulation of authorised Medicinal Products, Medical ...

13 Feb, 2019

• Regulatory Intelligence

‘No deal’ Brexit regulatory advice on medicines, devices and clinical trials

In this 'Brexit News' close-up our Regulatory Intelligence team will provide a commentary and updates on recent British ...

26 Oct, 2018

• Pharmacovigilance Blog

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 ...

24 Sep, 2018