IntroductionThe onset of the pandemic was one of the most hard-hitting events that impacted millions of people around the globe. On one hand it brought along life-changing repercussions and challenges that were first of many, but it also triggered industries to adopt innovative solutions in their everyday practices. One of these many solutions was instigating […]
Real-Time Remote Inspections – The New Normal Read More »
The healthcare sector has been significantly impacted by technology, with the rapid growth of digital health applications projected to continue due to increased demand for remote healthcare services, especially during the COVID-19 pandemic [1]. According to the US FDA, software-based medical devices are increasingly being used for diagnosing, treating, and monitoring complex diseases. The adoption
Rise of Digital Applications in the Healthcare Sector Read More »
IntroductionThe practice of pharmacovigilance revolves around patient safety by improving the benefit-risk balance of a pharmaceutical product. This is done by alleviating the extent of the adverse reaction associated with it or by enhancing its benefit. Routine minimization measures such as specific dosing regimens, warnings & precautions communication through labeling , patient follow-ups, relevant testing
Additional Risk Minimization Measures: Pregnancy Prevention Programme Read More »
The Eprex®-pure red cell aplasia case of 1998 engendered the understanding the perhaps the safety associated with biosimilars cannot be extrapolated from the innovator medicine as in the case of generics. Although generics and biosimilars are similar in the manner that they are both permitted for marketing only after expiry of the patent of the
Pharmacovigilance for Biosimilars vs pharmacovigilance for generics Read More »
Introduction to Pharmacovigilance in Japan,USA and EU The International Conference on Harmonization of Technical Requirements for the registration of pharmaceuticals for human use, or the ICH, was formed to facilitate harmonization of requirements and procedures among member states to ensure safe, efficacious, and high-quality drugs reach the market. The founding regulatory members include the European
An overview on pharmacovigilance in Japan, USA, Europe Read More »
Overview Pharmacovigilance (PV) and post-market surveillance is important to capture the safety profile of a drug. The entire information on a benefit-risk ratio & safety profile is not known until or unless the drug has reached the market and been used in a larger, much wider population. Hence, a systematic approach in monitoring and evaluating
What do you need to know about aggregate reporting? Read More »
Overview A drug is authorized by an agency only when it demonstrates a positive risk management-benefit balance or safety profile for the target population. It is a key component of Pharmacovigilance (PV) to safeguard public health. However, information on drug safety gathered from monitoring clinical trials is limited and, at times, not relevant to the larger population
Components of a risk management plan in pharmacovigilance Read More »
Individual Case Safety Reports (ICSRs) are a key aspect of pharmacovigilance (PV) and post-market safety surveillance as they provide crucial safety information for an approved pharmaceutical product, and a holistic view of the safety profile of the drug, including its benefit-risk profile, which is important to mitigate patient harm. The main steps involved in ICSR
Challenges in ICSR processing Read More »
A signal is information that arises from single or multiple source/s that may suggest a potential causal association between a drug and event given that the causal relationship between drug & event were previously unknown or inadequately documented. These signals are used for risk-benefit evaluation of a product and emerging safety issues that would cause
Role and Importance Signal Management in Pharmacovigilance Read More »
Regulatory authorities around the world conduct pharmacovigilance (PV) inspections to verify that marketing authorization holders (MAHs) and allied organizations maintain compliance with PV requirements, obligations, and relevant standards. This applies to products as well as processes. National competent authorities appoint inspectors to conduct these inspections which can be announced or unannounced. If the former, then
