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: \;Session 1 of 4Date: Thursday 8th October 2026Time: 16:00 - 17:30 GMTLocation: Online via ZoomWho is this event intended for? \ ;Statisticians\, Clinicians and Safety Scientists conducting aggregate saf ety 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.Over viewThis PSI/EFSPI webinar\, co-organized with PHUSE and the ASA Biopharm Safety Working Group\, provides an overview of safety reporting requiremen ts and safety surveillance in ongoing clinical trials. The session will ex plore 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 agg regate safety monitoring\, including practical challenges\, safety surveil lance processes\, and real-world approaches to supporting compliant and ef fective safety oversight during clinical development. As the first webinar in a planned series on safety in clinical trials\, this session will esta blish the foundational concepts needed to understand more advanced topics in subsequent events.RegistrationThis webinar is free to attend for PSI Me mbers &\; Non-Members.To register for this event\, please \;click h ere.Speaker detailsSpeaker\n Biography\n Presentation Abstract\n Naomi Giv ens\, Statistics Director\, GSKNaomi Givens is a Statistics Director at GS K with more than 25 years of experience in pharmaceutical drug development . She currently supports the HIV portfolio and has held a broad range of t echnical\, strategic and leadership roles across all phases of development \, contributing to programmes from Phase II through regulatory submission and lifecycle management.Naomi has interest in benefit-risk assessment and drug safety. She previously led the GSK Biostatistics Safety Working Grou p\, serves as Global Process Owner for the Data Monitoring Committee proce ss\, and is an active member of the PSI Benefit-Risk Special Interest Grou p\, where she co-leads the Safety Implementation Working Group with Dooti Roy. She is currently Chair of PSI.Meeting facilitatorRima Izem\, Director in Biostatistics\, Novartis\n Dr Rima Izem is Real World Evidence Scienti fic Lead in the Advanced Quantitative Sciences group at Novartis in Basel\ , Switzerland. She has nearly 20 years of experience in pharmaceutical res earch\, including ten years at the US Food and Drug Administration and pri or academic appointments. Her work has supported benefit-risk evaluation a nd regulatory decision-making across multiple therapeutic areas and throug hout the product lifecycle\, from clinical development to the post-authori zation setting. Her recent interests include the application of causal inf erence methods and hybrid study designs that integrate evidence from clini cal trials and real-world data sources\, particularly in rare events and r are diseases.\n Introduction to Safety Assessments in Clini cal TrialsThis presentation will provide an introduction of safety evaluat ion in clinical trials. This will begin by outlining the key scientific ob jectives that underpin these evaluations\, including the protection of tri al participants and the evaluation of a treatment&rsquo\;s benefit-risk pr ofile. Then\, the presentation will introduce some safety- specific termin ology\, concepts\, and/or principles and illustrate these concepts on a to y example. The presentation will put recent methodological development\, e xisting methods and challenges\, in a historical context of evolving legis lation\, guidelines\, and advances in therapeutic development.Katarina Hed man\, Statistical Science Director\, \;AstraZenecaDr Katarina Hedman i s Statistical Science Director in Biometrics Cardiovascular\, Renal and Me tabolic (CVRM) group at AstraZeneca\, Gothenburg. With over 20 years in li fe science research\, she has led the AstraZeneca CVRM Safety Working Grou p for the past five years\, advancing best practices in the planning and p resentation of safety analyses in CVRM clinical trials. Under her leadersh ip\, the group has been at the forefront of adopting the PHUSE Safety Work ing Group white papers and FDA guidance in this area\, embedding them into everyday practice.Katarina is also one of the leaders of the newly starte d PHUSE project "Best Practices for Informing Benefit&ndash\;Risk and Comm unicating Safety Information"\, which is currently calling for volunteers. PHUSE Package of Educational Slide Decks on Safety EstimandsThis presentat ion gives a brief introduction to the forthcoming PHUSE package of educati onal slide decks on implementing estimands in clinical trial safety analys es. The package covers five themes: estimand fundamentals\; intercurrent e vents\; from estimand to estimators\; estimands for aggregated analysis ac ross multiple studies\; and communication and implementation. The full pac kage will soon be published in the PHUSE Safety Library. \;Matthias Tr ampisch\, Expert TAM Statistician\, Boehringer Ingelheim\n Dr. Matthias Tr ampisch is an Expert TAM Statistician and independent statistician (iSTAT) within the Independent Statistical Analysis Team (iSAT) at Boehringer Ing elheim\, where he has been supporting independent statistical activities f or almost 10 years now. He provides statistical support to Data Monitoring Committees (DMCs) and conducts independent unblinded analyses during ongo ing 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 t hrough robust independent review processes. He played a key role in establ ishing Boehringer Ingelheim's statistical framework\, standards\, and proc esses for independent analyses and serves as an R Governance Process Owner (R GPO)\, supporting the compliant and sustainable use of R across the or ganization.\n Beyond Individual Cases: Operationalizing FDA IND Safety Reporting for Anticipated Serious Adverse EventsThe FDA requir es expedited reporting of suspected unexpected serious adverse reactions ( SUSARs) during clinical trials\, including the assessment of anticipated s erious adverse events (SAEs). Implementing these requirements &ndash\; spe cifically for the assessment of anticipated events - can be challenging\, particularly when unblinded analyses are needed to evaluate treatment grou p imbalances while preserving trial integrity. This presentation discusses practical approaches for conducting independent unblinded safety analyses \, comparing external CRO models with internal Independent Statistical Ana lysis Teams (iSATs). Key topics include governance\, Safety Surveillance P lans\, trigger-based and periodic review strategies\, output validation\, and maintaining operational independence. The session provides recommendat ions for selecting and implementing an effective safety surveillance model that supports regulatory compliance\, patient safety\, and scientific rig or. \;Matteo Pedone\, GSKMatteo Pedone is a Principal Statistician in GSK Vaccines\, where he has been part of the Quantitative Sciences and Inn ovation methodological team since February 2023. His current interests cen ter on mediation models\, predictive models\, and futility rules for clini cal trials. He previously supported protocol and statistical analysis plan development for early-phase vaccine and HIV trials within GSK's Bacterial Vaccines biostatistics group\, and contributed to work on safety signal d etection\, Bayesian causal mediation models\, and sample size re-estimatio n. He holds a Ph.D. in Statistics from the University of Florence\, where his research focused on covariate-dependent Bayesian models for heterogene ous populations. His broader work spans Bayesian nonparametrics\, variable selection\, and causal inference\, with applications to microbiome data\, adaptive clinical trials\, and precision medicine. \;From Theory to P ractice: Implementing BDRIBS for Blinded Safety SurveillanceThis presentat ion uses a realistic toy example to demonstrate how sponsor project teams can design and implement Bayesian Detection of potential Risk using Infere nce on Blinded Safety Data (BDRIBS) as a blinded safety surveillance strat egy. Attendees will gain an understanding of the statistical principles un derpinning BDRIBS\, explore key implementation considerations\, and discus s practical challenges and opportunities when deploying the approach in cl inical development programs.We hope to spark a discussion on barriers to i mplementation\, and would welcome attendees sharing their own experiences with blinded safety surveillance methods.Alex Spiers\, GSKAlex is a statis tician at GSK's Quantitative Sciences Innovation group\, working as part o f a team that develops novel methods and creates tools to support the impl ementation of high-impact statistics methodology in clinical trials. His m ethodological work spans multiplicity strategies\, trial design\, and he m aintains the open-source {multigrain} R package for optimising graphical m ultiple testing. Alex began his career teaching science in London comprehe nsive schools through the Teach First programme. After completing his MSc in Applied Statistics from Birkbeck\, University of London\, he worked bri efly as a Data Science Consultant at DecisionLab\, developing machine lear ning and simulation models for clients in government and the water industr y. In 2019\, he began his PhD in Epidemiology and Biostatistics at Imperia l College London\, focusing on adolescent mental health. His career focus in clinical trials began in 2022 when he joined the clinical trials unit a t King's College London's Institute of Psychiatry\, Psychology and Neurosc ience as a research associate statistician\, before joining GSK in 2023. I n addition to his work at GSK\, Alex remains dedicated to STEM outreach\, both as a volunteer giving talks and workshops to schools and as a member of the PSI Careers Schools committee. \;From Theory to Practice: Imple menting BDRIBS for Blinded Safety SurveillanceThis presentation uses a rea listic toy example to demonstrate how sponsor project teams can design and implement Bayesian Detection of potential Risk using Inference on Blinded Safety Data (BDRIBS) as a blinded safety surveillance strategy. Attendees will gain an understanding of the statistical principles underpinning BDR IBS\, explore key implementation considerations\, and discuss practical ch allenges and opportunities when deploying the approach in clinical develop ment programs.We hope to spark a discussion on barriers to implementation\ , and would welcome attendees sharing their own experiences with blinded s afety surveillance methods. \; DTEND:20261008T173000Z DTSTAMP:20261009T104709Z 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:RFCALITEM639271396295622840 X-ALT-DESC;FMTTYPE=text/html:


 \;

Session 1 of 4

Date: Thursday 8th October 2026
Tim e: 16:00 - 17:30 GMT
Location: Online via Z oom

W ho is this event intended for? \;Statisticians\, Clinicians and Safety S cientists 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 rep orting requirements and safety surveillance in ongoing clinical trials. Th e session will explore the regulatory framework underpinning safety monito ring\, including serious adverse event reporting\, assessment of emerging safety signals\, governance considerations\, and approaches for maintainin g trial integrity.

Through presentations from industry experts\, att endees will gain insight into both the scientific principles and operation al implementation of aggregate safety monitoring\, including practical cha llenges\, safety surveillance processes\, and real-world approaches to sup porting compliant and effective safety oversight during clinical developme nt. As the first webinar in a planned series on safety in clinical trials\ , this session will establish the foundational concepts needed to understa nd more advanced topics in subsequent events.

Registration

This webinar is free to a ttend for PSI Members &\; Non-Members.
To register for this event\ , please \;cli ck here.

Speaker details

Speaker\n Biography\n Presentation Abstract\n

Naomi Givens\, Sta tistics Director\, GSK

Naomi Givens is a Statistics Director at GSK with more than 25 ye ars of experience in pharmaceutical drug development. She currently suppor ts the HIV portfolio and has held a broad range of technical\, strategic a nd leadership roles across all phases of development\, contributing to pro grammes from Phase II through regulatory submission and lifecycle manageme nt.

Naomi has interest in benefit-risk assessment and drug safety. S he previously led the GSK Biostatistics Safety Working Group\, serves as G lobal Process Owner for the Data Monitoring Committee process\, and is an active member of the PSI Benefit-Risk Special Interest Group\, where she c o-leads the Safety Implementation Working Group with Dooti Roy. She is cur rently Chair of PSI.

< p>Meeting facilitator

Rima Izem\, Director in Biostatistics\, Nov artis\n

Dr Ri ma Izem is Real World Evidence Scientific Lead in the Advanced Quantitativ e Sciences group at Novartis in Basel\, Switzerland. She has nearly 20 yea rs of experience in pharmaceutical research\, including ten years at the U S Food and Drug Administration and prior academic appointments. Her work h as supported benefit-risk evaluation and regulatory decision-making across multiple therapeutic areas and throughout the product lifecycle\, from cl inical development to the post-authorization setting. Her recent interests include the application of causal inference methods and hybrid study desi gns that integrate evidence from clinical trials and real-world data sourc es\, particularly in rare events and rare diseases.\n

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Introduction to Safety Assessments in Clinical Trials

This presentation wi ll provide an introduction of safety evaluation in clinical trials. This w ill begin by outlining the key scientific objectives that underpin these e valuations\, including the protection of trial participants and the evalua tion of a treatment&rsquo\;s benefit-risk profile. Then\, the presentation will introduce some safety- specific terminology\, concepts\, and/or prin ciples and illustrate these concepts on a toy example. The presentation wi ll put recent methodological development\, existing methods and challenges \, in a historical context of evolving legislation\, guidelines\, and adva nces in therapeutic development.

Katarina Hedman\, Statistical Science Director\, \;AstraZeneca

Dr Katarina Hed man is Statistical Science Director in Biometrics Cardiovascular\, Renal a nd Metabolic (CVRM) group at AstraZeneca\, Gothenburg. With over 20 years in life science research\, she has led the AstraZeneca CVRM Safety Working Group for the past five years\, advancing best practices in the planning and presentation of safety analyses in CVRM clinical trials. Under her lea dership\, the group has been at the forefront of adopting the PHUSE Safety Working Group white papers and FDA guidance in this area\, embedding them into everyday practice.

Katarina is also one of the leaders of the newly started PHUSE project "Best Practices for Informing Benefit&ndas h\;Risk and Communicating Safety Information"\, which is currently ca lling for volunteers.

PHUSE Package of Educational Slide Decks on Safety Estimands

This presentation gives a brief introduction to the forthcoming PHUSE package of educational slide decks on implementi ng estimands in clinical trial safety analyses. The package covers five th emes: estimand fundamentals\; intercurrent events\; from estimand to estim ators\; estimands for aggregated analysis across multiple studies\; and co mmunication and implementation. The full package will soon be published in the PHUSE Safety Library.

 \;

Matthias Trampisch\, Expert TAM Statistician\, Boehringer Ingelheim\n

Dr. Matthias Trampisch is an Expert TAM Statistician and independent statistician (iSTAT) within th e Independent Statistical Analysis Team (iSAT) at Boehringer Ingelheim\, w here he has been supporting independent statistical activities for almost 10 years now. He provides statistical support to Data Monitoring Committee s (DMCs) and conducts independent unblinded analyses during ongoing clinic al trials\, including assessments of anticipated serious adverse events (S AEs) and emerging safety signals. His work focuses on supporting FDA IND s afety reporting requirements while maintaining trial integrity through rob ust independent review processes. He played a key role in establishing Boe hringer 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 .\n

Beyond Individual Cases: Operationalizing FDA IND Safety Reportin g for Anticipated Serious Adverse Events

The FDA requires e xpedited reporting of suspected unexpected serious adverse reactions (SUSA Rs) during clinical trials\, including the assessment of anticipated serio us adverse events (SAEs). Implementing these requirements &ndash\; specifi cally for the assessment of anticipated events - can be challenging\, part icularly when unblinded analyses are needed to evaluate treatment group im balances while preserving trial integrity.

This presentation discus ses practical approaches for conducting independent unblinded safety analy ses\, comparing external CRO models with internal Independent Statistical Analysis Teams (iSATs). Key topics include governance\, Safety Surveillanc e Plans\, trigger-based and periodic review strategies\, output validation \, and maintaining operational independence.

The session provides reco mmendations for selecting and implementing an effective safety surveillanc e model that supports regulatory compliance\, patient safety\, and scienti fic rigor.

 \;

Matteo Pedone\, GSK

Matteo Pedone is a Princi pal Statistician in GSK Vaccines\, where he has been part of the Quantitat ive Sciences and Innovation methodological team since February 2023. His c urrent interests center on mediation models\, predictive models\, and futi lity rules for clinical trials. He previously supported protocol and stati stical analysis plan development for early-phase vaccine and HIV trials wi thin GSK's Bacterial Vaccines biostatistics group\, and contributed to wor k on safety signal detection\, Bayesian causal mediation models\, and samp le size re-estimation. He holds a Ph.D. in Statistics from the University of Florence\, where his research focused on covariate-dependent Bayesian m odels for heterogeneous populations. His broader work spans Bayesian nonpa rametrics\, variable selection\, and causal inference\, with applications to microbiome data\, adaptive clinical trials\, and precision medicine.

 \;

From Theory to Practice: Implementing BDRIBS for Blinded Safety Surveilla nce

This presentation uses a realistic toy example to demonstrate how sponsor project teams can design and implement Bayesian D etection of potential Risk using Inference on Blinded Safety Data (BDRIBS) as a blinded safety surveillance strategy. Attendees will gain an underst anding of the statistical principles underpinning BDRIBS\, explore key imp lementation considerations\, and discuss practical challenges and opportun ities when deploying the approach in clinical development programs.
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We hope to spark a discussion on barriers to implementation\, and wo uld welcome attendees sharing their own experiences with blinded safety su rveillance methods.

< em>Alex Spiers\, GSK

Alex is a statistician at GSK's Quantitative Sciences Innovation gr oup\, working as part of a team that develops novel methods and creates to ols to support the implementation of high-impact statistics methodology in clinical trials. His methodological work spans multiplicity strategies\, trial design\, and he maintains the open-source {multigrain} R package for optimising graphical multiple testing. Alex began his career teaching sci ence in London comprehensive schools through the Teach First programme. Af ter completing his MSc in Applied Statistics from Birkbeck\, University of London\, he worked briefly as a Data Science Consultant at DecisionLab\, developing machine learning and simulation models for clients in governmen t and the water industry. In 2019\, he began his PhD in Epidemiology and B iostatistics at Imperial College London\, focusing on adolescent mental he alth. His career focus in clinical trials began in 2022 when he joined the clinical trials unit at King's College London's Institute of Psychiatry\, Psychology and Neuroscience as a research associate statistician\, before joining GSK in 2023. In addition to his work at GSK\, Alex remains dedica ted to STEM outreach\, both as a volunteer giving talks and workshops to s chools and as a member of the PSI Careers Schools committee.

 \;

From Theor y to Practice: Implementing BDRIBS for Blinded Safety Surveillance

This presentation uses a realistic toy example to demonstrat e how sponsor project teams can design and implement Bayesian Detection of potential Risk using Inference on Blinded Safety Data (BDRIBS) as a blind ed safety surveillance strategy. Attendees will gain an understanding of t he statistical principles underpinning BDRIBS\, explore key implementation considerations\, and discuss practical challenges and opportunities when deploying the approach in clinical development programs.

We ho pe to spark a discussion on barriers to implementation\, and would welcome attendees sharing their own experiences with blinded safety surveillance methods.

 \;

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