BEGIN:VCALENDAR VERSION:2.0 METHOD:PUBLISH PRODID:-//Telerik Inc.//Sitefinity CMS 15.4//EN BEGIN:VTIMEZONE TZID:UTC BEGIN:STANDARD DTSTART;VALUE=DATE:20250101 TZNAME:UTC TZOFFSETFROM:+0000 TZOFFSETTO:+0000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DESCRIPTION:Date: Thursday 8th October 2026Time: \;16:00 - 17:30 GMTLoc ation: \;Online via ZoomWho is this event intended for? \;Statisti cians conducting aggregate safety monitoring of clinical trials.What is th e benefit of attending? \;Understand the regulatory requirements\, pot ential barriers and practical considerations when monitoring safety data i n ongoing clinical trials.OverviewThis PSI/EFSPI webinar\, co-organized wi th PHUSE and the ASA Biopharm Safety Working Group\, provides an overview of safety reporting requirements and safety surveillance in ongoing clinic al 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 f or maintaining trial integrity.Through presentations from industry experts \, attendees will gain insight into both the scientific principles and ope rational implementation of aggregate safety monitoring\, including practic al challenges\, safety surveillance processes\, and real-world approaches to supporting compliant and effective safety oversight during clinical dev elopment. As the first webinar in a planned series on safety in clinical t rials\, this session will establish the foundational concepts needed to un derstand more advanced topics in subsequent events.RegistrationThis webina r is free to attend for PSI Members &\; Non-Members.To register for thi s event\, please \;click here.Speaker detailsSpeaker\n Biography\n Pre sentation Abstract\n Rima Izem\, Director in Biostatistics\, Novartis\n Dr Rima Izem is Real World Evidence Scientific Lead in the Advanced Quantita tive Sciences group at Novartis in Basel\, Switzerland. She has nearly 20 years of experience in pharmaceutical research\, including ten years at th e US Food and Drug Administration and prior academic appointments. Her wor k has supported benefit-risk evaluation and regulatory decision-making acr oss multiple therapeutic areas and throughout the product lifecycle\, from clinical development to the post-authorization setting. Her recent intere sts include the application of causal inference methods and hybrid study d esigns that integrate evidence from clinical trials and real-world data so urces\, particularly in rare events and rare diseases.\n This prese ntation will provide an introduction of safety evaluation in clinical tria ls. This will begin by outlining the key scientific objectives that underp in these evaluations\, including the protection of trial participants and the evaluation of a treatment&rsquo\;s benefit-risk profile. Then\, the pr esentation will introduce some safety- specific terminology\, concepts\, a nd/or principles and illustrate these concepts on a toy example. The prese ntation will put recent methodological development\, existing methods and challenges\, in a historical context of evolving legislation\, guidelines\ , and advances in therapeutic development.Matthias Trampisch\, Expert TAM Statistician\, Boehringer Ingelheim\n Dr. Matthias Trampisch is an Expert TAM Statistician and independent statistician (iSTAT) within the Independe nt Statistical Analysis Team (iSAT) at Boehringer Ingelheim\, where he has been supporting independent statistical activities for almost 10 years no w. He provides statistical support to Data Monitoring Committees (DMCs) an d conducts independent unblinded analyses during ongoing clinical trials\, including assessments of anticipated serious adverse events (SAEs) and em erging safety signals. His work focuses on supporting FDA IND safety repor ting requirements while maintaining trial integrity through robust indepen dent review processes. He played a key role in establishing Boehringer Ing elheim'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.\n Beyond Individual Cases: Operationalizing FDA IND Safety Reporting for Ant icipated Serious Adverse EventsThe FDA requires expedited reporting of sus pected unexpected serious adverse reactions (SUSARs) during clinical trial s\, including the assessment of anticipated serious adverse events (SAEs). Implementing these requirements &ndash\; specifically for the assessment of anticipated events - can be challenging\, particularly when unblinded a nalyses are needed to evaluate treatment group imbalances while preserving trial integrity. This presentation discusses practical approaches for con ducting independent unblinded safety analyses\, comparing external CRO mod els with internal Independent Statistical Analysis Teams (iSATs). Key topi cs include governance\, Safety Surveillance Plans\, trigger-based and peri odic review strategies\, output validation\, and maintaining operational i ndependence. The session provides recommendations for selecting and implem enting an effective safety surveillance model that supports regulatory com pliance\, patient safety\, and scientific rigor. \;TBC\n  \;Demons tration using a toy example of how a sponsor project team could plan and i mplement a Bayesian Detection of potential Risk using Inference on Blinded Safety data (BDRIBS) as an example of a blinded trigger approach. DTEND:20261008T173000Z DTSTAMP:20260828T130602Z DTSTART:20261008T160000Z LOCATION: SEQUENCE:0 SUMMARY:Joint PSI/EFSPI\, Phuse\, ASA Safety Working Group Webinar Series: Overview of safety analysis and implementation process of safety surveilla nce in ongoing studies UID:RFCALITEM639235191621999067 X-ALT-DESC;FMTTYPE=text/html:

Date: Thursday 8th October 2026
Time: \;16:00 - 17:30 GMT
Loc ation: \;Online via Zoom

Who is this event intended for? \;Statistic ians conducting aggregate safety monitoring of clinical trials.

What is the benefit of attending? \;Unde rstand the regulatory requirements\, potential barriers and practical cons iderations when monitoring safety data in ongoing clinical trials.

Overview

This PSI/EFSPI webinar\, co-organized with PHUSE and the A SA Biopharm Safety Working Group\, provides an overview of safety reportin g requirements and safety surveillance in ongoing clinical trials. The ses sion will explore the regulatory framework underpinning safety monitoring\ , including serious adverse event reporting\, assessment of emerging safet y signals\, governance considerations\, and approaches for maintaining tri al integrity.

Through presentations from industry experts\, attendee s will gain insight into both the scientific principles and operational im plementation of aggregate safety monitoring\, including practical challeng es\, safety surveillance processes\, and real-world approaches to supporti ng compliant and effective safety oversight during clinical development. A s the first webinar in a planned series on safety in clinical trials\, thi s session will establish the foundational concepts needed to understand mo re advanced topics in subsequent events.

Registration

This webinar is free to attend for PSI Members &\; Non-Members.
To register for this event\, ple ase \;click he re.

Speaker details

Speaker\n Biography\n < strong>Presentation Abstract\n

Rima Izem\, Director in Biostatistics\, Novartis\n

Dr Rima Izem is Real World Evidence Scientific Lead in the A dvanced Quantitative Sciences group at Novartis in Basel\, Switzerland. Sh e has nearly 20 years of experience in pharmaceutical research\, including ten years at the US Food and Drug Administration and prior academic appoi ntments. Her work has supported benefit-risk evaluation and regulatory dec ision-making across multiple therapeutic areas and throughout the product lifecycle\, from clinical development to the post-authorization setting. H er recent interests include the application of causal inference methods an d hybrid study designs that integrate evidence from clinical trials and re al-world data sources\, particularly in rare events and rare diseases.\n

This present ation 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 th e evaluation of a treatment&rsquo\;s benefit-risk profile. Then\, the pres entation will introduce some safety- specific terminology\, concepts\, and /or principles and illustrate these concepts on a toy example. The present ation will put recent methodological development\, existing methods and ch allenges\, in a historical context of evolving legislation\, guidelines\, and advances in therapeutic development.

Matt hias Trampisch\, Expert TAM Statistician\, Boehringer Ingelheim\n

Dr. Matthias Trampisc h is an Expert TAM Statistician and independent statistician (iSTAT) withi n the Independent Statistical Analysis Team (iSAT) at Boehringer Ingelheim \, where he has been supporting independent statistical activities for alm ost 10 years now. He provides statistical support to Data Monitoring Commi ttees (DMCs) and conducts independent unblinded analyses during ongoing cl inical trials\, including assessments of anticipated serious adverse event s (SAEs) and emerging safety signals. His work focuses on supporting FDA I ND 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 GP O)\, supporting the compliant and sustainable use of R across the organiza tion.\n

Beyond Individual Cases: Operationalizing FDA IND Safety Reporting fo r Anticipated Serious Adverse Events

The FDA requires exped ited reporting of suspected unexpected serious adverse reactions (SUSARs) during clinical trials\, including the assessment of anticipated serious a dverse events (SAEs). Implementing these requirements &ndash\; specificall y for the assessment of anticipated events - can be challenging\, particul arly when unblinded analyses are needed to evaluate treatment group imbala nces while preserving trial integrity.

This presentation discusses practical approaches for conducting independent unblinded safety analyses\ , comparing external CRO models with internal Independent Statistical Anal ysis Teams (iSATs). Key topics include governance\, Safety Surveillance Pl ans\, trigger-based and periodic review strategies\, output validation\, a nd maintaining operational independence.

The session provides recommen dations for selecting and implementing an effective safety surveillance mo del that supports regulatory compliance\, patient safety\, and scientific rigor.

 \;

TBC\n

 \;

Demonstration using a toy example of how a sponsor project team could plan and implement a Bayesian Detection o f potential Risk using Inference on Blinded Safety data (BDRIBS) as an exa mple of a blinded trigger approach.

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