Pharmacovigilance (PV) is a challenging field and identifying and minimising risks is a complex process never more so than in early phase clinical trials. New adverse events (AEs) continue to be added to the list of expected events for a product years after it has been licensed and treated millions of people. So how can a Sponsor hope to characterise the safety of an Investigational Medicinal Product (IMP) during their early phase ‘safety’ studies, with such limited data and patient numbers, why is it so important to get it right at this stage and what are the knock-on effects if it is done badly?
This webinar looks to highlight some of the major challenges of PV in early phase clinical trials and what can be done to overcome them. We demonstrate the importance of PV in early phase clinical trials and how it is not just a check box exercise to satisfy regulatory bodies. There will be a particular focus on oncology, where patients can be expected to have multiple complex and confounding comorbidities and treatments.
This session is designed for those starting out in their drug safety career in clinical trials, or those with post-marketing experience looking for a change in focus and who want to understand how PV applies to early phase clinical trials.
Tom Nichols, Senior Director, Pharmacovigilance, Quanticate
Tom has over 8 years of experience in Pharmacovigilance including clinical phases I-IV as well as post-marketing. He is proficient in Argus and ARISg database administration and is qualified to use EVWeb and XEVMPD. Tom’s project experience includes; regional lead on global database migration and consolidation, new GvP and Clinical Trial Regulation readiness and implementation groups, EMA Stakeholder Subgroup H ‘Safety Reporting’ member, as well as ensuring audit/ Inspection readiness and CAPA delivery. He is a member of PIPA Committee Member and lead of the PV Regulations and Guidelines work stream. After a number of years working in the generics sector, Tom was most recently overseeing safety in high-risk, early phase oncology trials, including many First-in-Class or First-in-Man.
Who Should Attend?
Intermediate professionals who currently work in clinical trials, working in post marketing with an interest in PV.
Influencers or decisions makers in clinical trials who are interested in outsourcing PV.
Clinicians who may not be aware of the benefits of a targeted PV approach further down the developmental path of an IMP.
Quanticate, headquartered in the UK and USA, is a leading global Clinical Research Organization (CRO) primarily focused on the management, analysis and reporting of data from clinical trials and post-marketing surveillance. As The Clinical Data Experts our team provides high quality, efficient outsourcing solutions for companies who need additional capacity or who want to outsource certain activities in their entirety.
Our clinical and post-marketing services include scalable on-site and off-site clinical data management, biostatistics, clinical programming, PK/PD analysis, medical writing, pharmacovigilance and consultancy. Quanticate was announced a five category winner in the annual CRO Leadership Awards for Quality, Reliability, Productivity, Regulatory and Innovation. Quanticate was the first CRO to introduce the Centralized Service Provision (CSP) approach to outsourcing supported by its data centralization and visualization tool for both single study and cross-study data analysis. Please visit the website at www.quanticate.com for further information and access to white papers.