Pharmacovigilance

• Risk Assessment and Control of Elemental Impurities (ICH Q3D)

• Periodic Safety Update Reports (PSURs)

With the implementation of the EU Guideline for Elemental Impurities (ICH Q3D, step 5 from 25 July 2016), the requirements on the pharmacovigilance activities of pharmaceutical manufactures increased markedly, resulting in additional personnel expenditure and amount of time. According to Guideline ICH Q3D, all marketing authorisation holders are required to perform a risk assessment to identify any elemental impurities that may potentially be present at significant levels in the drug product. Such an assessment is then used to define an appropriate control strategy to ensure that the potential elemental impurities do not exceed the PDE (permitted daily exposure). If changes to the drug product or components have the potential to change the elemental impurity content of the drug product, the risk assessment, including established controls for elemental impurities, should be re-evaluated (i.e., lifecycle management).

Time for implementation of Guideline ICH Q3D in pharmaceutical companies is tight, because the date for coming into effect is June 2016 for new marketing authorization applications and December 2017 for authorized medicinal products.

We support pharmaceutical companies in implementing the Guideline for Elemental Impurities (ICH Q3D). We identify, classify and quantify elemental impurities in a medicinal product and perform the risk assessment. Furthermore, we create a control strategy for a medicinal product that assures that elemental impurities do not exceed the PDEs and provide patients at the very best in safety. At your request, we also  support you in the monitoring and assessment of the effectiveness of risk minimisation measures.

Due to our cooperation with a highly qualified analytics laboratory, we are able to offer our customers all services from a single source and thus spare them the necessity of time-consuming coordination of the overall project ICH Q3D.

Periodic Safety Update Reports (PSURs)

The GVP Module VII (Periodic Safety Update Report, from December 2013)  provides guidance on the preparation, submission and assessment of Periodic Safety Update Reports (PSURs). According to this guidance, the main objective of PSURs is to present a critical and comprehensive analysis of the benefit-risk profile of a medicinal product taking into account new or emerging information in the cumulative benefit-risk analysis. The PSUR is a tool for post-authorisation evaluation at defined time points in the lifecycle of a product. For the purposes of lifecycle benefit-risk management, it is necessary to continue evaluating the risks and benefits of a medicine in everyday medical practice and long term use in the post-authorisation phase.

We prepare submittable PSURs for your medicinal products in line with the actual regulatory requirements (GVP Module VII). We evaluate your company-specific data on an individual basis and include the results of detailed research on adverse drug reactions in the scientific literature. We discuss the relevant publications and suspected cases when evaluating to the risk-benefit ratio of the pharmacological active compounds. The adverse reaction notifications for the drugs are prepared and evaluated in the corresponding line listings and summary tabulations. Furthermore we compile the Addendum or Bridging Reports for clients and write clinical expert statements for renewals.