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For the past 2 years the EMA has been monitoring nationally authorised medicines via the single assessment of periodic safety update reports (PSURs). Based on collective feedback from their experience, the agency has now published recommendations as part of its commitment to continuous process improvement.
Companies know only too well that the majority of their regulatory workforce is focused on product lifecycle management. Post-approval safety data management is just one of the various data streams that companies have to regularly assess and manage, so any attempts by the agencies to help streamline the process are always welcomed.
With regards to this specific update, PSURs are reports that evaluate the benefit-risk balance of a medicine as evidence is gathered in clinical use. These updates are then submitted at defined intervals by the licence holder to the agency. The Agency then uses the information found in the PSURs to determine if there are new risks linked to a medicine, or if the balance of benefits and risks of a medicine has changed. Based on this information, the EMA decides whether further investigations are needed or whether measures have to be taken to protect public health, generally via updated product information for healthcare professionals and patients. If medicinal products contain the same active substance or the same combination of active substances, the related PSURs will be jointly assessed in a single assessment procedure.
As a part of this process the EMA has released two new documents aimed at improving the safety information and benefit-risk assessment of medicines in the context of the periodic safety update single assessment (PSUSA): ‘Explanatory note to GVP Module VII’ and ‘Assessors’ questions and answers (Q&A) guidance on PSUR single assessment (PSUSA)’. The explanatory note addresses issues that have been raised by companies during two years of running the single assessment process. The Q&A document guides assessors throughout the evaluation process of PSURs to improve standards and increase consistency.
The introduction of single assessments has helped to ensure that all the evidence generated about medicines containing the same active substance is reviewed at the same time by one authority, resulting in consistent safety information. The joint assessment helps to optimise use of resources between national competent authorities. Single assessments of periodic safety update reports are a key post-marketing regulatory tool to ensure patients receive up-to-date information on the safety of medicines. The EMA now plans to organise joint training in the second quarter of 2017 for the pharmaceutical industry and EU national competent authorities to support the implementation of the optimised single assessment process.
At ELC Group we provide an ISO-accredited pharmacovigilance service and we are best placed to help your organisation manage the rapidly changing environment within pharmacovigilance. We have recently launched our one-stop service which now includes medical information services. We look forward to helping you plan, execute and maximise your regulatory capabilities relating to any current and future changes as they arise.