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Impact of digital transformation on Pharmacovigilance (PV) operations

Impact of digital transformation on Pharmacovigilance (PV) operations

The pharmaceutical industry is set to embrace transformation initiatives at a faster pace over the coming years, across clinical, regulatory and safety practices. In product development, companies are focused on streamlining end-to-end processes to speed time to market and maintain regulatory compliance at all times. Pharmacovigilance being a highly regulated domain, requires careful planning and management during this time. There are many pain areas in the day to day PV operations for which the service providers...

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Regulatory submissions of ICSRs in PV operations: Scope and Challenges

Given the international dimension of adverse reactions reporting and the need to achieve harmonisation and high quality between all involved parties, ICSRs should be submitted electronically as structured data with the use of controlled vocabularies for the relevant data elements where applicable. Scope of ICSR submissions: Expeditedness assessment Only valid ICSRs should be submitted. Submission of a valid ICSR can be decided as per it’s expeditedness. This expeditedness depends upon the seriousness criteria and labelling parameters which...

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How automation will help to overcome the current challenges in pharmacovigilance (PV) operations

How automation will help to overcome the current challenges in pharmacovigilance (PV) operations

Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. There are many significant approaches were considered while developing the overall process of pharmacovigilance i.e. how these activities like detection, assessment, understanding, and prevention will be carried out in actual PV operations. The significant approach towards pharmacovigilance planning was initially developed by EMA via proposing the GVP module-VI (i.e. Guideline on...

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Importance of vaccine pharmacovigilance (PV) in current COVID-19 pandemic

Importance of vaccine pharmacovigilance (PV) in current COVID-19 pandemic

Vaccine pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding, prevention, and communication of adverse events following immunization (AEFIs), or of any other vaccine or immunization-related issues. We all may be aware that vaccines are among the most important medical interventions for prevention of illness and life-threatening conditions especially in emergency situations like the ongoing COVID-19 pandemic. In current era of COVID-19 vaccine research, many reputed pharma giants like GSK, Roche,...

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Operational productivity and quality monitoring: An integral part of PV operations

Operational productivity and quality management system is an integral aspect of any pharmacovigilance (PV) operations team which is dealing with the dedicated end to end ICSR case processing activities. Operational quality and operational productivity management system is also an important part of the performance management system which involves tracking of the quarterly, half yearly, and yearly quality and productivity of whole ICSR case processing team with the perspective of annual appraisals. The overall market reputation of...

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Product quality complaint

Product Inquiry Trail and Response system (PrITR)

Management of medical inquiries, product complaints and adverse events due to the complaints is critical for any pharmaceutical company. In current era of pharmacovigilance, the newly updated regulations from regulators for reporting of adverse events, product inquiry, product quality complaint, and medical inquiry makes it difficult to automate these processes. It is necessary for the pharma companies to have the automated solutions at place to avoid use of their valuable resources on these cumbersome tasks....

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PvD’code: A Smart EV triage solution

New Eudravigilance system was launched on November 22nd, 2017, and a prominent revision was made via transition of technical transmission of Individual Case Safety Reports (ICSRs) from ICH E2B (R2) to ICH E2B (R3) format. ICH E2B (R3) format proposed a new opportunity to gain greater insights into ICSRs and the benefit-risk profile of medicines due to the improved visibility of the data and the quality of ICSRs.   This upgrade, however, also introduced the industry to technical challenges which required detailed preparation and a lengthy planning to maintain regulatory compliance, as increasing...

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Automated literature surveillance: A much needed enhancement for Marketing authorization holders and Service providers in pharmacovigilance (PV)

The medical literature monitoring (MLM) is a significant source of information for the monitoring of the safety profile and of the risk-benefit balance of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues. Hence, it is important to review suspected adverse reaction gathered from scientific journals, medical researcher, relevant published abstract and draft manuscripts. Need for medical literature monitoring (MLM) Marketing authorization holders (MAH) are therefore expected to maintain awareness...

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Artificial intelligence and Machine learning

Artificial intelligence and Machine learning in Pharmacovigilance (PV) operations

Much of the effort in PV is focused on identifying, collecting, evaluating, and transforming relevant data into usable information for regulators and companies to address safety concerns and inform the public and prescribers. The volume of individual case safety reports (ICSRs) increases yearly, but it is estimated that more than 90% of AEs go unreported. Also, there is an unprecedented rise in data volumes coming from journals, patents, articles, social media, and non-standardized data sources. The...

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Continuous refinement of Pharmacovigilance regulations in Arab countries

Continuous refinement of Pharmacovigilance regulations in Arab countriesPharmacovigilance (PV) significance and cognizance is constantly growing amongst pharma and biotech Industry, health care segments and masses at large. The Arab countries have also gained impetus and shown incessant refinement in gearing their countries towards attaining universal Pharmacovigilance observance goals. Beholding the regulations so far, Egyptian Drug Authority (EDA), Egyptian Pharmaceutical Vigilance Center (EPVC) has guidelines and legislations defined for a robust pharmacovigilance system.