I had the pleasure of attending the 4th Annual pharmacovigilance conference in Dubai on the 15th January. It was a very interesting conference that certainly opened my eyes to how far the Middle East had progressed with regards to implementation of pharmacovigilance requirements. I was asked to present on best practices for QPPV officers, however I quickly learnt that we were speaking the same words but they meant different things to the audience. What I mean by that is that the guideline on Good Pharmacovigilance for Arab countries has just been published in December 2014 for implementation in July 2015. This covers all the available GVP modules with some amends for national purposes. Whilst the majority of the document is very much the same, there are some differences. In particular regarding the QPPV the following is stated in module I:
As part of the pharmacovigilance system, the marketing authorisation holder shall have permanently and continuously at its disposal an appropriately qualified person responsible for pharmacovigilance (QPPV) in the Arab Country concerned. For multinational MAHs a Local Safety Responsible (LSR) may be accepted in some Arab Countries; consult national medicines authorities for national requirements.
This did bring some complexities when giving my talk on the QPPV as the focus was on the EU QPPV, however this needed to translate to the QPPV defined as above.
There was an interesting presentation given on the Pharmacovigilance System Master File (PSMF), where Moin Din went through the PSMF requirements and the higher level thinking behind having a functioning pharmacovigilance system. Interestingly within GVP for Arab Countries, there is a very specific checklist for training for the QPPV that should be ticked for practical experience although there can be a column for training during the transition period.
- Pharmacovigilance methods
- MedDRA coding.
- ICSRs processing activities
- Evidence based –medicine, How to conduct literature search.
- Causality assessment
- Case Narrative Writing for Reporting Adverse Events
- Pharmacovigilance quality management
- Signal detection
- Medical Aspects of Adverse Drug Reactions
- Risk benefit assessment in Pharmacovigilance
- National pharmacovigilance regulations
- How to prepare PSUR
- Pharmacovigilance Planning and Risk Management Plans
- How to prepare PSMF
- Risk communication, DHPC
Additionally the QPPV should have the qualifications as specified below:
Minimum of bachelor degree of pharmacy or medicine, basic training in epidemiology and biostatistics (for KSA only he; should be also licensed by Saudi Commission for Health Specialties). In addition; they should have the skill for the management of pharmacovigilance systems as well as expertise or access to expertise in relevant areas such as medicine, pharmaceutical sciences as well as epidemiology and biostatistics.
It is recognised that the PSMF may be a global or EU document and in that case where there is a LSR there should be a national pharmacovigilance sub-system file (national PSSF) which needs to include local information and documents describing the pharmacovigilance sub-system at the national level in the Arab country concerned. The PSSF should also be up to date and be permanently available to the LSR, with a focus on the national pharmacovigilance subsystems
Dr Anju Agarwal from Macleods Pharmaceuticals Ltd (Mumbai) discussed risk management plans and the complexity of global and local needs and what can be used from the global document for local submission. GVP for Arab countries states that there may be a need for local activity and there should be a discussion of the need for supplementary activities in the RMP for each region, although there will be core elements common to all. The MAH will then need to submit:
- the most updated version of the EU RMP (referenced EU RMP including its annexes);
- the National Display of the RMP (including its annexes) see Annex II.3 for template.
Overall the conference provided a forum to not only share our learnings from the EU but also to understand the issues associated with implementing quite stringent requirements in territories where perhaps resourcing is still not optimal, potentially impacting on compliance. The value of pharmacovigilance is probably still underestimated outside of pharmacovigilance departments within the regions and the guidelines are leading to difficult conversations regarding resource needs for these activities that were had within the EU a few years ago, until the discipline became fully embedded. One can understand these problems and in the EU we are in a good place to offer pragmatic solutions to our colleagues in the Gulf. Also, even though multinational companies may have their QPPV already, within the Arab area they are not willing to have a local company presence and as such are affiliated with local companies, which means the need for the local QPPV is further compounded. From the conference it was very clear to see that the willingness and eagerness to ensure best practice in pharmacovigilance was there, but the battle is likely to still be uphill for the moment.