Welcome to this month’s edition of ICYMI from Acorn Regulatory – looking at articles from the Acorn Regulatory archive that you might have missed when they were first published. This month in ICYMI from Acorn Regulatory we are looking at the Worksharing Procedure, RMP’s (Risk Management Plans), the need for Key Performance Indicator’s in Pharmacovigilance and how you can better prepare for a PV inspection. here. here. MHRA publish pharmacovigilance inspection metrics each year. 2015-2016 has seen the number of inspections continue to fall with 34 inspections in this period compared with 47 for 2014-2015 and 56 for the period 2013 to 2014. These yearly reports, together with our own experience of MHRA pharmacovigilance audits over the years, have given us an insight on the changing focus of the inspectorate since the introduction of the revised Good Pharmacovigilance Practice in June 2012. In the latest reporting period (April 2015 to March 2016), the most commonly cited critical finding was ‘Supervision and oversight’ at 28%. This category includes issues in relation to the provision of complete and accurate information to national competent authorities and inspectors, maintenance of the PSMF and QPPV/ MAH oversight of the pharmacovigilance system. ‘MAH oversight’ accounted for 11% of critical findings in 2014-2015 and was not listed as a category in the 2013-2014 report. This represents an upward trend in findings in this area. The second most cited category for critical findings in 2015-2016 was both ‘Data management’ and ‘Reference safety information (RSI)’, both at 18%. RSI includes failures and significant delays to submit safety variations to update the safety sections of SPCs and PILs. RSI seems to have seen an improvement in MAH compliance in recent years, as it represented 29% and 42% of critical findings in 2014-2015 and 2013-2014, respectively. Data management was not a category in previous reports, and includes issues with collation and integrity of the global safety dataset, ICSR handling and safety database validation, configuration and control. Read the full article here. here. If you would like to stay up to date with everything that is happening in the industry and at Acorn Regulatory then you should sign up to receive our monthly newsletter. You can sign up below. [ninja_form id=8] You can also read more ICYMI from Acorn Regulatory articles by visiting our news and articles page here.