In Case You Missed It – Articles from the Archive -#ICYMI

Welcome to this month’s edition of #ICYMI – looking at articles from the Acorn Regulatory archive that you might have missed when they were first published.

This month 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.

The Worksharing Procedure for Variations for National Marketing Authorisations in the EU

Did you know that Article 20 of Commission Regulation (EC) N° 1234/2008 (the ‘Variations Regulation’) allows for a Marketing Authorisation Holder to submit the same Type IB or Type II variation, or the same group of variations affecting more than one marketing authorisation from the same Marketing Authorisation, in one application?

In this article we answer 4 important questions related to the worksharing concept in this article.

Read the full article here.

PV KPI’s: Pharmacovigilance Key Performance Indicators – An Overview

Our expert team has many years experience of working with clients to ensure that their pharmacovigilance systems are continuously improving.  In this blog we look at PV KPI’s and the steps that your company can take.

Key performance indicators (KPI) are a set of quantifiable measures that a company uses to gauge its performance over time. These quantifiable measures can be used to indicate how a well a pharmacovigilance system is performing and whether the system is continually improving. The demands on a PV system vary depending on number of products concerned, the nature of the products and the life cycle and regulatory demands placed on the products.

Read the full article here.

Pharmacovigilance Inspection: Are You Prepared?

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.

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 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.

Risk Management Plans (RMP) for Healthcare Companies

To address risk minimisation, Healthcare companies are required to have RMPs (Risk Management Plans) in place to document identified and potential risks of a drug. A RMP will include an Action Plan outlining risk minimisation activities that are carried out to reduce the probability of an adverse reaction occurring, or its severity should it occur. The governing EU directive is;

DIRECTIVE 2001/83/EC as amended, 28b Risk management system: a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to a medicinal product, including the assessment of the effectiveness of those activities and interventions.  28c. Risk management plan: a detailed description of the risk management system.

Read the article about Risk management Plans here.

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