Qinecsa appoints Arthur Shih as General Counsel
6 November 2023, London – Qinecsa Solutions, specialists in technology-led end-to-end pharmacovigilance solutions, today announced the appointment of Arthur Shih as General Counsel. With over 25 years in private practice and in-house leadership roles, Arthur brings extensive international legal and commercial experience to support the execution of Qinecsa’s future growth strategy. “Qinecsa is a market-leader […]
Introducing the Qinecsa PV Insights Network: Connecting peers for practical drug safety solutions
Empowering leaders in small pharma and biotech with responsibility for drug safety We are thrilled to announce the launch of the Qinecsa PV Insights Network, an initiative designed specifically for pharmacovigilance (PV) leaders in small pharma and biotech companies who bear the critical responsibility of drug safety. Following the overwhelming response to a series of […]
Join Qinecsa at World Drug Safety Congress US, 18-19 October, Boston
We are thrilled to be heading back to Boston to attend the World Drug Safety Congress US, which brings together 1000+ top leaders and stakeholders in biopharma to discuss the key challenges they are facing in pharmacovigilance and device safety. Our team of experts is looking forward to being part of the discussions regarding strategies in […]
Join Qinecsa at World Drug Safety Congress Europe, 4-5 October, Amsterdam
Our team is delighted to once again be attending the World Drug Safety Congress Europe, which brings together 1500+ key thought leaders to explore key challenges in pharmacovigilance. From exploring the use of big data and AI in pharmacovigilance, examining benefit-risk management strategies and patient-centric approaches, drug safety is at the forefront of innovative technologies […]
Fit-for-future sourcing for pharmacovigilance: Embracing Change for Success
Author: Humaira Qureshi, President of Qinecsa Solutions The pharmacovigilance industry is in an unprecedented era of change. PV teams are experiencing year-on-year increases in case volumes, driven in part by increased awareness and reporting by patients. Regulatory agencies are embracing the opportunities provided by innovation and technology, and the rise in methods and formats to […]
Join Qinecsa at 32nd Pharmacovigilance 2023, 26-27 April, Boston
Join Qinecsa at 32nd Pharmacovigilance 2023 to discuss the latest developments in pharmacovigilance, drug safety & risk management.Our President, Humaira Qureshi, will present ‘Fit for future sourcing for pharmacovigilance’ where she will discuss the drivers for change in the pharmacovigilance industry, the challenges faced by PV teams, and how traditional models of delivery need to […]
Compliant drug safety framework for early phase clinical trials
A biotech had successfully completed Phase I clinical trials and was rapidly progressing into Phase II. Serious adverse event (SAE) volume was expected to significantly increase and therefore associated workload could not be managed in-house. Qinecsa established a compliant and robust drug safety framework in line with budget and quality expectations to manage increased case […]
Cost-effective drug safety systems and solutions
A small pharma client with limited budget had several clinical compounds in Phase I and II, and one globally approved commercial product. They required robust processes for the evaluation of single and aggregate data to strengthen stakeholder review and documentation management associated with serious adverse events (SAEs).
Developing a robust drug safety framework
A small biotech with a healthy development pipeline had no internal pharmacovigilance expertise. They required a compliant drug safety framework to support safety data collection, evaluation, and dissemination during clinical trials. Qinecsa established a simple, compliant drug safety framework, including a suite of policies and procedures in line with relevant legislation, to support collection, evaluation, […]
Transforming data into decisions
Dr Andrew Rut recently presented at the PV Legal Forum in Chicago on the importance of collecting and analyzing holistic safety data in order to make good decisions for individual patients needing treatments. Disconnected systems lead to gaps and errors in the pharmacovigilance process: There is a lack of information at market authorization as clinical […]
