Pharmacovigilance QP

Question 1

Describe pharmacovigilance and the key aspects of pharmacovigilance system

Answer 1

Pharmacovigilance – also known as drug safety, is the pharmaceutical science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
PSMF – MA Holder, Updated regularly – trending, organogram, CV of QPPV, Individual Case Safety Reports,
QPPV- Interaction with Quality, EU – QPPV sits in EU and UK – representative in UK
Complaints- adverse event reporting and FMD and lack of efficacy and Medical Risk Assessments
Regulatory - MA Approval and CTA Approval – Extended Medical Dictionary (Article 57)

Question 2

You have an oncology product, there has been a change to the manufacturing process resulting in increased variation in the process, the last four batches have had a low assay value, how would you deal with this and what discussion involvement would you have with the QPPV

Answer 2

Review Change Control and Impact Assessment
Any Stability samples available?
Is it OOS or OOT ?
Has there been any complaints for lack of efficacy , adverse trends

Question 3

PV regulations and guidance

Answer 3

MHRA document: Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders and the licensing authority
The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (SI 2019 No. 775)
The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (SI 2019 No. 1385)
The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (SI 2020 No. 1488)
Directive 2001/83/EC as amended, on the Community code relating to medicinal products for human use (DIR).
Regulation (EC) No. 726/2004 as amended, laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (REG).
Commission Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (IR).

Question 4

Consequently, and in respect of pharmacovigilance, the following legal provisions will apply to UK marketing authorisations (MA)

Answer 4

Those in Part 11 (Pharmacovigilance) of the HMR will apply to all UK MAs, unless expressly stated otherwise.
Those in Schedule 12A (further provision as to the performance of pharmacovigilance activities) of the HMR will apply to products authorised for sale or supply in Great Britain only; * those in the IR will apply to products authorised for sale or supply in the UK and Northern Ireland only.