IT issues during pharmacovigilance audits and inspections
VigiServe Foundation Blog
by Manoj Swaminathan
4M ago
In today’s world of information technology (IT) advancement, where everyone is talking about artificial intelligence, and robotics. Automation, and machine learning. It is rather unlikely that things would go wrong during an audit or inspection, more so specifically due to a trivial reason that is related to IT connectivity, network, or even infrastructure. Such issues ..read more
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Pharmacovigilance Audit Universe
VigiServe Foundation Blog
by Manoj Swaminathan
5M ago
The pharmacovigilance audit universe consists of 100% of audit targets which will be audited in a span of 2-5 years. This information forms a part of the strategic audit plan that includes the auditing target, risk assessment, frequency and the year when audit will be performed. Audit targets These may include distributors, business partners, affiliates ..read more
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Process audits in pharmacovigilance
VigiServe Foundation Blog
by Manoj Swaminathan
5M ago
The pharmacovigilance audit universe is not limited to the distributors, business partners, affiliates,and vendors / service providers. One also needs to consider pharmacovigilance processes as well as processes of cross-functional departments which may have a direct or indirect impact on patient safety compliance. These processes are not limited to: Information Technology Of the above-listed process ..read more
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Managing document requests during an Inspection
VigiServe Foundation Blog
by Manoj Swaminathan
5M ago
It is at the discretion of an inspector to request documents prior to, during, and after an inspection. A document request after an inspection may call for a surprise even if the closing meeting was uneventful. On-site Vs Remote For obvious reasons, remote inspections are expected to have more document requests prior to the inspection ..read more
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Audits and Due-diligence in Pharmacovigilance
VigiServe Foundation Blog
by Manoj Swaminathan
6M ago
In the present era, we are witnessing quite a lot of mergers and acquisitions (M&A) in the pharma industry. As a result, the concept of due diligence is gaining a lot of importance. Although there is some similarity between audits and due diligence with regards to the review of the systems, the purpose is different ..read more
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PSMF Audit – What do you look for?
VigiServe Foundation Blog
by Manoj Swaminathan
6M ago
The Pharmacovigilance System Master File (PSMF) stands as a crucial document in the realm of Good Pharmacovigilance Practice (GVP). It has been a cornerstone of the guidelines put forth by the European Medicines Agency back in 2012. Regular ad-hoc reviews of the PSMF are a common practice, particularly during audits or due diligence processes. It ..read more
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Automation opportunities in Medical Information
VigiServe Foundation Blog
by Manoj Swaminathan
1y ago
A robot for handling calls When we think of medical information, the first thing that comes to mind is a call centre representative working in the 9-5 shift and providing information regarding a particular medicine. Imagine if this activity is performed by a robot that is available 24/7/365 and can understand every language and access all the information regarding the company’s medicinal products; you can ask questions in any language, and you are assured a response in the same language within 30 seconds! This is going to be the future of medical information. In the era of machine learning, yo ..read more
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Safety Labeling Non-Compliance
VigiServe Foundation Blog
by Manoj Swaminathan
1y ago
By safety labels, we refer to the cartons, packaging materials, prescribing information, reference safety information or even the patient information leaflet or consumer information guide, which may contain relevant safety information. The associated safety text gets updated whenever there is any update to the safety profile of the product. The prescribers, pharmacists, nurses, care-givers, or even the patients may refer to these labels and hence it is essential these are updated at all times. In some countries there is a concept of Urgent Safety Restrictions, where the marketing authorization ..read more
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Distributor Non-Compliance
VigiServe Foundation Blog
by Manoj Swaminathan
1y ago
By distributor, we mean the business partners who support the commercialization of the company products in the concerned territories. We won’t discuss about the non-compliance areas, but provide considerations for the marketing authorization holder (MAH) for ensuring compliance. Every MAH can’t have commercial operations in every country in which it holds licenses. This may even apply to large countries where the MAH has limited operations, e.g., an MAH operating in the US (which has 50 states in all) but having commercial operations in only 25 states. The MAH may consider having a commercial ..read more
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PSMF for the Veterinary Medicinal Products
VigiServe Foundation Blog
by Manoj Swaminathan
1y ago
The European Medicines Agency introduced the concept of PSMf, and it became effective in July 2012. Until then, the marketing authorization holders (MAH) maintained a detailed description of the Pharmacovigilance system (DDPS). However, the requirement was restricted to human medicinal products (HMP). For veterinary medicinal products (VMP), the requirement continued to be the maintenance of DDPS until January 2022, when the veterinary good pharmacovigilance practice (vGVP) guidelines became effective. The PSMF for VMP differs from that for HMP (GVP Module 2). One common thing is that we have ..read more
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