QVigilance Blog & Regulatory Updates

  • 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 ...

  • Brexit News

QPPV and PSMF requirements update in case of no-deal Brexit

On 12 Mar 2019, Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance on qualified person ...

  • 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 ...

  • 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 ...

  • 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 ...

  • 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 ...

  • 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 ...