Are You Prepared for a Pharmacovigilance Inspection?
A pharmacovigilance inspection can be a daunting prospect for many companies. Since 2002 we have worked with countless companies to guide them through their inspections. In this article, we look at the measures that your company can take to be prepared.
MHRA Inspection Metrics
In the UK, the 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 April 2015 to March 2016 reporting period, 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.
On major findings in 2015-2016, the top two cited were signal management (24%) and ICSR management (18%). Here in Ireland, the HPRA conduct a limited number of PV inspections each year, with only 2 pharmacovigilance inspections taking place in 2015 (HPRA Annual report 2015).
Ask yourself the following questions….
From our experience with the MHRA, a key focus at present is QPPV oversight and influence. The QPPV must continue to be aware of all aspects of safety related to the medicinal product(s). This is an extremely wide net and QPPVs should be able to satisfy themselves with all of the following, as outlined in GVP module 1:
- Does your QPPV have the skills for the management of the pharmacovigilance system and have adequate theoretical and practical knowledge? Simply assigning a member of staff to this position that does not have extensive experience in the area is not acceptable, and will be cited by national competent authorities.
- Is the information in the PSMF accurate and up to date at all times? Is it a true reflection of the how the pharmacovigilance system is executed on a day-to-day basis?
- Do you have sufficient oversight of all third parties, for example distributors? Have you got robust safety data exchange agreements in place? Are you performing reconciliation activities at appropriate intervals? Have you ensured all third parties have received initial and refresher pharmacovigilance training? Have all third parties been included on your audit schedule? Have you assessed risks when deciding on your audit plan for third parties?
- Do you have oversight over the functioning of the system in all relevant aspects, including its quality system (e.g. standard operating procedures, contractual arrangements, database operations, compliance data regarding quality, completeness and timeliness of expedited reporting and submission of periodic update reports, audit reports and training of personnel in relation to pharmacovigilance).
We Can Help
Here at Acorn Regulatory, we have an experienced pharmacovigilance team that can help you prepare for your pharmacovigilance inspection. Or why not get in touch today to see if we can help you on an on-going basis to meet your legal requirements in Europe with respect to pharmacovigilance.
Further Reading from Acorn Regulatory
Veterinary Clinical Trials: New EU Law & Global Approaches
Clinical studies are intended to advance animal health care by identifying the most effective therapies and practices for a given condition, or by advancing our basic understanding of the disease. Much like a clinical study in the human population, a veterinary clinical study involves research that gains information from animal patients.
Pharmacovigilance & Social Media in 2020
We have been tracking the role of social media in pharmacovigilance in social media since 2015. We first wrote about it here. 5 years on, we are glad to say that the field has moved on substantially in terms of research into the practical applications of social media in Pharmacovigilance. Regulatory guidance for the industry, however, has yet to be updated.
Download Our Clinical Trials E-Book
Acorn Regulatory is a leading regulatory, pharmacovigilance and clinical consultancy company headquartered in Ireland. Our Clinical & Medical team works with the largest and the leading companies in life sciences to assist them in bringing their products to market. The team, led by Dr. Danica Cvetkovic, has written extensively on the issue. In the latest e-book from Acorn Regulatory, we look at the best and most popular articles from our Clinical & Medical team.
A Practical Approach to Risk Management Plans
Writing a risk management plan (RMP) for the first time can be a daunting task. The RMP is a legally binding regulatory document submitted to health authorities and is a mandatory commitment for all Marketing Authorisation Holders in the European Union. The goal of the RMP is to improve the benefit-risk balance of a medicinal product by combining risk assessment and risk minimisation. The RMP is a complex document, but with the revised RMP module (March 2017), comes the revised EU template for RMPs (rev 2 format) and the RMP is now structured in a clear manner with less repetition and with attention to detail.