Joint PSI/EFSPI, Phuse, ASA Safety Working Group Webinar Series: Overview of safety analysis and implementation process of safety surveillance in ongoing studies
Date: Thursday 8th October 2026
Time: 16:00 - 17:30 GMT
Location: Online via Zoom
Who is this event intended for? Statisticians conducting aggregate safety monitoring of clinical trials.
What is the benefit of attending? Understand the regulatory requirements, potential barriers and practical considerations when monitoring safety data in ongoing clinical trials.
Overview
This PSI/EFSPI webinar, co-organized with PHUSE and the ASA Biopharm Safety Working Group, provides an overview of safety reporting requirements and safety surveillance in ongoing clinical trials. The session will explore the regulatory framework underpinning safety monitoring, including serious adverse event reporting, assessment of emerging safety signals, governance considerations, and approaches for maintaining trial integrity.
Through presentations from industry experts, attendees will gain insight into both the scientific principles and operational implementation of aggregate safety monitoring, including practical challenges, safety surveillance processes, and real-world approaches to supporting compliant and effective safety oversight during clinical development. As the first webinar in a planned series on safety in clinical trials, this session will establish the foundational concepts needed to understand more advanced topics in subsequent events.
Registration
This webinar is free to attend for PSI Members & Non-Members.
To register for this event, please click here.
Speaker details
| Speaker
| Biography
| Presentation Abstract
|
.png?sfvrsn=3867a9db_1 "Untitled design (6)") Rima Izem, Director in Biostatistics, Novartis
| Dr Rima Izem is Real World Evidence Scientific Lead in the Advanced Quantitative Sciences group at Novartis in Basel, Switzerland. She has nearly 20 years of experience in pharmaceutical research, including ten years at the US Food and Drug Administration and prior academic appointments. Her work has supported benefit-risk evaluation and regulatory decision-making across multiple therapeutic areas and throughout the product lifecycle, from clinical development to the post-authorization setting. Her recent interests include the application of causal inference methods and hybrid study designs that integrate evidence from clinical trials and real-world data sources, particularly in rare events and rare diseases.
| This presentation will provide an introduction of safety evaluation in clinical trials. This will begin by outlining the key scientific objectives that underpin these evaluations, including the protection of trial participants and the evaluation of a treatment’s benefit-risk profile. Then, the presentation will introduce some safety- specific terminology, concepts, and/or principles and illustrate these concepts on a toy example. The presentation will put recent methodological development, existing methods and challenges, in a historical context of evolving legislation, guidelines, and advances in therapeutic development. |
.png?sfvrsn=8264a9db_1 "Untitled design (7)") Matthias Trampisch, Expert TAM Statistician, Boehringer Ingelheim
| Dr. Matthias Trampisch is an Expert TAM Statistician and independent statistician (iSTAT) within the Independent Statistical Analysis Team (iSAT) at Boehringer Ingelheim, where he has been supporting independent statistical activities for almost 10 years now. He provides statistical support to Data Monitoring Committees (DMCs) and conducts independent unblinded analyses during ongoing clinical trials, including assessments of anticipated serious adverse events (SAEs) and emerging safety signals. His work focuses on supporting FDA IND safety reporting requirements while maintaining trial integrity through robust independent review processes. He played a key role in establishing Boehringer Ingelheim's statistical framework, standards, and processes for independent analyses and serves as an R Governance Process Owner (R GPO), supporting the compliant and sustainable use of R across the organization.
| Beyond Individual Cases: Operationalizing FDA IND Safety Reporting for Anticipated Serious Adverse Events The FDA requires expedited reporting of suspected unexpected serious adverse reactions (SUSARs) during clinical trials, including the assessment of anticipated serious adverse events (SAEs). Implementing these requirements – specifically for the assessment of anticipated events - can be challenging, particularly when unblinded analyses are needed to evaluate treatment group imbalances while preserving trial integrity. This presentation discusses practical approaches for conducting independent unblinded safety analyses, comparing external CRO models with internal Independent Statistical Analysis Teams (iSATs). Key topics include governance, Safety Surveillance Plans, trigger-based and periodic review strategies, output validation, and maintaining operational independence. The session provides recommendations for selecting and implementing an effective safety surveillance model that supports regulatory compliance, patient safety, and scientific rigor. |
TBC
| | Demonstration using a toy example of how a sponsor project team could plan and implement a Bayesian Detection of potential Risk using Inference on Blinded Safety data (BDRIBS) as an example of a blinded trigger approach. |
