Pharmacovigilance Requirements for UK Authorized Products
MHRA webinars regarding PV requirements for UK authorized products after Bexit
MHRA have recently published two webinars explaining post-transition period and how it is going to affect Pharmacovigilance requirements for UK-authorized products.
First webinar which was held on October 2020 and recording was published on 17 December 2020 covers basic elements such as PSMF, QPPV, registration on MHRA portal as well as aggregated reports, ICSRs and safety variations submissions:
| Post Transition: Pharmacovigilance Requirements for UK Authorised Products – without Q&A |
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Second webinar which was held on 1 January 2021 and recording was published on 25 January 2021 and after the end of transition period, covers the legal frame works, GVP modules and goes further into details of PSMF (UK-PSMF) and QPPV (UK-QPPV) as well as MHRA PV inspections and risk assessments:
| Pharmacovigilance requirements for UK authorised products – without Q&A |
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If you are in doubt or have any question, you can always contact us via info@pharmazet.com and we will deliver tailored solutions and answers for your requirements and queries!