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.