This first session of the conference, chaired by J Vijay Venkatraman, gave the audience a broad overview of the state of flux in pharmacovigilance, essentially resulting from changes initiated in Europe – the impact of evolving Eudrovigilance, Brexit and E2B R3 were the focal points.
In terms of Eudrovigilance, Dr Mangesh Kulkarni gave brief descriptions of the various Eudrovigilance gateway systems involved and explained that there was access to the information submitted to these systems as a whole. Access is not simple though, he explained, since only personnel with permission from the QPPV could do so, and then there are restrictions on the periods of access (only previous 105 days), after which further individual queries needed to be lodged. He noted that the Eudravigilance data output was in the excel format.
Dr Vijay noted that transition of reporting from the E2B R2 to R3 format was not yet 100% complete, and so R2 reporting was still permitted by the EMA. He also commented that there was some ongoing quality reviews being carried out concerning the backward and forward conversion of the R2 and R3 formats.
The last point made was that, the imminent implement of the changes to the CT Regulation EU N# 536/2014 would allow harmonisation of assessments and would make reporting of SUSARs much more simple.
A last minute change in presenter was necessary for the next topic: “Brexit and its Pharmacovigilance After Effects”.
Although she apologised in advance for perhaps not being as fluid as she would have liked, Dr Ute Hoeffner was most eloquent in presenting the excellent information created by Seema Jaitly.
In essence, the current indecision relating to the final terms of the “exit”, has meant that there remains uncertainty regarding some aspects of governance and responsibilities for PV activities in the UK in the wake of the breakup.
What is known, is that industry is preparing for the worst case “no deal” scenario.
This will mean that UK can no longer be a rapporteur/co- rapporteur for an MAH that is established in the EEA.
Ute spoke of orphan drugs and explained that the sponsors in these cases also have to be in the EEA and not the UK. She shared a list of “redistributed” products, but added that if the licence had been granted before March 30th 2019, there should be no change….. although she did share with the audience that she wondered whether this would perhaps change considering that Brexit did not actually happen on the proposed date.
Speaking of dates, she explained that now the UK has to have a National Licence within one year of the Brexit date. In order to maintain a UK licence, there is a large amount of data required, which she said (thankfully) the regulators were responsible for the associated work load.