Past PSI Events

Conferences

  • 02 Jun 2019

    PSI Conference 2019

  • 03 Jun 2018

    2018 PSI Annual Conference

    The 2018 PSI Conference held in Amsterdam on the 3-6 June broke more records by being the biggest PSI conference to date, with 391 delegates.
  • 14 May 2017

    2017 PSI Annual Conference

    The 2017 PSI Conference held in London on the 14-17 May was our most successful UK conference to date.
  • 22 May 2016

    2016 PSI Annual Conference

    The 2016 PSI conference took place at The Pullman Hotel, Berlin, between 22 to 25 May 2016. It was the 39th consecutive annual event.
  • 22 May 2016

    A PSI Pre-Conference Training Course

    A PSI Pre-Conference Training Course on Subgroup Analysis Presented by Aaron Dane, Armin Koch, Ilya Lipkovich & Gerd Rosenkranz
  • 10 May 2015

    2015 PSI Annual Conference

    The 2015 PSI Annual Conference "Relevant Applications in a Changing Environment" took place at The Millennium Gloucester Hotel, London, between 10 – 13 May. It was the 38th consecutive annual event and attracted just under 300 delegates and exhibitors.
  • 11 May 2014

    2014 Annual Conference

    The 2014 PSI Annual Conference took place at The Tower Hotel, London, between 11 – 14 May. It was the 37th consecutive annual event and attracted over 300 delegates and exhibitors.

Scientific Meetings

  • 29 Oct 2019

    PSI One Day Meeting: Time-to-event and Recurrent Event Endpoints in Clinical Trials

  • 11 Sep 2019

    Impact of AI on Clinical Development

    In association with PSI, UCB and Cytel are delighted to invite you to join a symposium, educating on Artificial Intelligence (AI) approaches and their impact on clinical development.
  • 17 Jul 2019

    PSI One day Scientific meeting: The analysis and reporting of PROs in Clinical Trials

    The PSI Scientific Committee have put together this one day meeting to provide statisticians with introductions to PROs, how to include them in clinical trials, considerations about missing data, appropriate statistical methods to analyse and interpret the data and the perspective of an IQWiG assessor.
  • 24 Jun 2019

    PSI One day Scientific meeting, South West: Designing and Analysing Adaptive Trial Design Studies

    During this meeting we will hear about adaptive sample allocation for phase II/III designs, a new CONSORT extension reporting guideline for adaptive designs, regulatory aspects and case studies.
  • 02 Apr 2019

    PSI Toxicology SIG Workshop 2019

    This 1.5-day workshop will involve approximately 20 statisticians, focusing on discussions around “best practice” in the statistical analysis of various data types.​
  • 28 Mar 2019

    PSI One Day Meeting: New Starters SIG

    This is the inaugural meeting of the recently relaunched New Starters Special Interest Group. The aim of this meeting is to provide a relaxed environment for early career statisticians to network and interact with their peers across the industry.
  • 29 Jan 2019

    PSI One Day Meeting: New Emerging Topics around Estimands and ICH Addendum

    The draft ICH E9 addendum on estimands and sensitivity analysis was released back in July 2017 and (more than 1000) comments are back. All stakeholders are gaining the necessary experience and familiarity with estimands along with the associated challenges and methodologies. The language and thinking behind causal inference is well suited to this area.
  • 18 Sep 2018

    PSI One Day Meeting and Workshop: Real World Evidence: Generalisability of Treatment Comparisons for Decision Making

    RWE data are an increasingly valuable resource in drug development. One area where this data is being used regularly is in the generalisability of treatment comparisons. This event will focus on this topic and more specifically on new advances in indirect comparisons, generalizability approaches for clinical trial data into the real world setting and cross-design approaches combining observational and randomized data.
  • 24 Apr 2018

    PSI Toxicology SIG Workshop 2018

    The Toxicology SIG provides a forum for statisticians working in regulatory and investigative toxicology to discuss issues and interact with one another. This 1.5-day workshop will involve hopefully approximately 20 statisticians, focusing on discussions around “best practice” in the statistical analysis of various data types.
  • 28 Feb 2018

    PSI One Day Meeting: Bayesian Methods for Dose Finding and Biomarkers

  • 28 Nov 2017

    European Statistical Meeting: Latest Trends in Health Technology Assessments

    This 1-day scientific meeting will provide an update on latest trends in HTA, including: the Real-World Evidence Navigator tool created by the IMI GetReal project; the EUnetHTA Joint Action 3 initiative and methodology being researched; introduction to value-based frameworks and estimands in HTA. Patient perspectives in HTA will be discussed including how to involve patients in HTA and latest methods in patient reported outcomes. HTA related methodological considerations will be highlighted including approaches to handle treatment switching in HTA. Industry HTA case studies will also be presented.
  • 22 Nov 2017

    PSI One Day Meeting: Extrapolation

    Use of extrapolation techniques is playing an increasingly important role in the development of new medicines particularly with regard to special populations such as paediatrics and rare diseases. This meeting will include speakers from industry, academia and regulatory (including Rob Hemmings from MHRA).
  • 27 Sep 2017

    PSI One Day Meeting: Estimands – Examples for Statisticians!

    The PSI Scientific Committee have put together this one day meeting to provide Statisticians with real world examples of how Estimands have been defined. Presenters will give their insight into discussions with colleagues, working groups and regulators and there will be plenty of opportunity to ask your questions on defining an Estimand.
  • 19 Jun 2017

    PSI One Day Meeting: Career Young Statisticians

    The aim of this meeting is to provide a relaxed environment for career young statisticians where they can present and discuss various statistical topics and interact/network with other statisticians in similar positions to themselves.
  • 15 Jun 2017

    BBS / PSI One-day Event on Cancer Immunotherapy

    This joint Basel Biometric Society / PSI one day meeting will present an overview of the science and potential statistical challenges across a range of topics covering early and late phases of development, regulatory and health technology assessments.
  • 30 Mar 2017

    Free PSI Scientific Meeting. Translational Statistics: Ideas-Evidence-Innovation-Communication

    Speakers include John Hinde, Claire Brittain, Paul Frewer, Fabio Rigat, Thomas Jaki, Guiyuan Lei and Ricardus Vonk
  • 14 Mar 2017

    Toxicology SIG Workshop 2017

    The Toxicology SIG provides a forum for statisticians working in regulatory and investigative toxicology to discuss issues and interact with one another.
  • 02 Nov 2016

    PSI One Day Meeting: Sample Size Re-estimation – dealing with those known unknowns!

    The aim of this PSI one day meeting is to present an overview of available methods for sample size re-estimation together with several case studies where such methods have been used in late phase clinical trials.
  • 14 Sep 2016

    Time-to-Event and Recurrent Event Endpoints

    This exciting one-day workshop will cover a wide range of statistical aspects relating to event-driven trials. This is a joint event with the BBS (Basel Biometric Section of the Austro-Swiss Region of the IBS);
  • 05 Jul 2016

    The Design and Analysis of N of 1 Trials

    This course will present the latest thinking on n-of-1 trials and cover not only their analysis through SAS®, R® GenStat® and meta-analysis packages but also approaches to design.
  • 17 Jun 2016

    PSI One Day Meeting: Immunology Diseases

    During this one day meeting, PSI aims to cover a wide range of immunology diseases, design considerations and statistical challenges when working in this therapeutic area.160 +
  • 27 Apr 2016

    Use of Simulation in Clinical Trial Design

  • 13 Nov 2015

    PSI Respiratory One Day Meeting

    During this one day meeting, PSI aims to cover a wide range of respiratory diseases and design considerations when working in this therapeutic area. We hope that sharing between different areas; will stimulate interesting discussion and an opportunity to knowledge share.
  • 09 Oct 2015

    PSI Graphics One Day Meeting

    This PSI one day meeting aims to cover a wide variety of areas where graphics can, and are, being used within the pharmaceutical industry and beyond. By sharing and engaging in multiple and varied examples attendees will come away from the meeting with a renewed appreciation of the benefits of graphical representations and ideas of where these tools could prove useful within their own areas of work.
  • 28 Sep 2015

    European Statistical Meeting on Estimands

    Controversy and confusion exist on the definition and selection of appropriate estimands in the clinical trial context. This meeting will provide a forum to hear about the latest developments and discussions on this topic. Speakers include members of the ICH working group as well as representatives from academia, European regulatory bodies and industry. The day will end with a panel discussion including all speakers.
  • 07 Sep 2015

    Advanced Topics in Survival Analysis

    The course assumes familiarity with basic methods for summarising survival data, including estimates of the survivor function and the log rank test.
  • 29 Jun 2015

    Statistical Innovations in Clinical Trials

    London Area Symposium: Statistical Innovations in Clinical Trials at Amgen (Uxbridge) in collaboration with Cytel. Speakers are Peter Colman (UCB) Cyrus Mehta (Cytel), James Wason (MRC Biostatistics Unit, Cambridge), Kevin Carroll (kjcstatistics)
  • 19 Feb 2015

    Estimands Discussion Meeting

    In October 2014 the ICH Steering Committee endorsed a final Concept Paper with the goal of developing new regulatory guidance, suggested to be an Addendum to ICH E9, which promotes harmonised standards on the choice of estimands in clinical trials and an agreed framework for planning, conducting and interpreting sensitivity analyses of clinical trial data. An Expert Working Group sponsored by ICH has been established to further develop the concept and is due to report findings in December 2015. Frank Bretz and Chrissie Fletcher are the EFPIA representatives on the ICH E9(R1) Expert Working Group
  • 05 Nov 2014

    How do Data Monitoring Committees Operate?

    This one day meeting is aimed at people who serve on Data Monitoring Committees, people who organise them, and people involved in preparing statistical reports and safety listings for them. The day will cover the remit and organisation of DMC’s, together with speakers’ personal experiences of the proces
  • 03 Sep 2014

    Prior Elicitation

    This 1-day scientific meeting provides an opportunity to learn about some of the main techniques for incorporating historical data into study analyses using different discounting methods, and for eliciting expert prior information in situations where no or limited historical data are available.
  • 05 Jun 2014

    Communicating Complex Statistical Concepts

    With increased pressures to run smaller, quicker studies that need to deliver more answers than ever before we are tasked with designing innovative studies that can meet these demands but remain statistically sound. This 1-day meeting aims to address how we, as statisticians, can better communicate the underlying complex statistical methodology such that our clinical colleagues better understand the risks and the decisions they will be able to make at the end of the study.

Training Courses

  • 19 Nov 2019

    A PSI Training Course on ICH for Statisticians

    This course will give an overview of ICH guidelines for all statisticians in the setting of drug development trials and drug approval in the pharmaceutical industry.
  • 22 May 2019

    Estimands and Sensitivity Analysis in Clinical Trials

    In this course we provide an in-depth review of the estimand framework as laid out by the draft ICH E9 addendum and present case studies illustrating the implementation of this framework in clinical trials.
  • 07 Mar 2019

    Network Meta Analysis (NMA) for Statisticians

    This intensive course will cover all basic and advanced aspects of synthesis of evidence from studies comparing competing treatments for the same health condition. By the end of this course participants will have an understanding of the role and potential of network meta-analysis, the principles, steps and statistical methods involved; the biases that can distort indirect comparisons and network meta-analysis.
  • 26 Sep 2018

    Regulatory Interactions for Statisticians

    The course objective is to inform statisticians about the likely interactions they might have with regulatory agencies, both during a submission and at other times during drug development, and give advice on how to make these interactions most effective.
  • 20 Sep 2018

    Statistics Fundamentals of Clinical Trials for Non-Statisticians (or ‘How to speak stats in a day!’)

    This is a 1-day course, aimed to introduce statistics to people who work on Clinical Trials, but who are not Statisticians. No previous knowledge of Statistics is assumed as we start right at the beginning with the basics. Many practical examples are given and the emphasis is on application and understanding rather than the equations and the technical background.
  • 09 May 2018

    PSI Training Course: Multiple Testing in Confirmatory Clinical Trials

    This course will focus on the principles underlying multiple comparison procedures and their applications to confirmatory clinical trials. We will describe simple ways to construct valid multiple tests, and will explore how tests can be incorporated into recycling strategies.
  • 24 Apr 2018

    Health Technology Assessment (HTA)

    This 2-day course will provide an introduction to the methods of health technology assessment.
  • 06 Mar 2018

    A PSI Training Course on Missing Data

    The course will provide participants the opportunity to gain insight into some of the more useful new methodologies for missing data, with a view to being at the service of the real scientific question of interest.
  • 14 Nov 2017

    Statistics Fundamentals for Clinical Trials for Non-Statisticians (or ‘How to speak stats in a day!’)

    This is a 1-day course, aimed to introduce statistics to people who work on Clinical Trials, but who are not Statisticians. No previous knowledge of Statistics is assumed as we start right at the beginning with the basics. Many practical examples are given and the emphasis is on application and understanding rather than the equations and the technical background.
  • 21 Sep 2017

    Improving Influence and Increasing Impact: Essential Skills for Industry Statisticians

    This course will lead participants, in a non-threatening and encouraging atmosphere, through the process of understanding their own strengths and weaknesses and what this means when working as a strategic partner or as part of a larger team. It will include workshops to practice the skills and behaviours discussed.
  • 28 Jun 2017

    Estimating Sample Sizes in Clinical Trials

    The three most important aspects of a clinical trial are: design, design and design. A sample size estimate is just one aspect of a clinical study design. The course describes calculations for sample size estimation in the design of clinical trials. It will be highlighted how the objectives of a clinical trial will impact on sample size calculations. The course is a practical course and all methods will be illustrated with examples and case studies.
  • 01 Mar 2017

    Dose Finding in Drug Development using MCP-Mod

    This course will introduce and discuss methods for Phase II dose finding studies, including a review of basic multiple comparisons and modelling methods, as traditionally used in these studies. A unified strategy for designing and analysing dose finding trials denoted MCP-Mod, combining multiple comparisons and modelling, will be the focus of the course.
  • 26 Jan 2017

    Health Technology Assessment (HTA) Training Course

    Presented by Mark Sculpher, Neil Hawkins and members of the HTA SIG
  • 08 Nov 2016

    Introduction to Simulation

    The aim of this course is to provide participants an understanding simulation techniques. The 2 day course includes a variety of practical examples and example code will be provided in both SAS and R. Presented by Les Huson
  • 22 May 2016

    A PSI Pre-Conference Training Course

    A PSI Pre-Conference Training Course on Subgroup Analysis Presented by Aaron Dane, Armin Koch, Ilya Lipkovich & Gerd Rosenkranz
  • 08 Mar 2016

    Structured Benefit-Risk Assessment – Methodology and Practice

    The 2 day course includes a practical workshop whereby participants will critically evaluate the benefit-risk balance of medicinal and healthcare product(s) in a robust and transparent manner.
  • 24 Nov 2015

    Advanced Concepts in Adaptive Design

    A PSI Training Course on Advanced Concepts in Adaptive Design.
  • 21 Oct 2015

    Introduction to Simulation

    This course provides an introduction to simulation techniques as applied to problems in the design and analysis of clinical trials.
  • 13 Oct 2015

    Toxicology SIG Workshop

    The Toxicology SIG provides a forum for statisticians working in regulatory and investigative toxicology to discuss issues and interact with one another.​
  • 20 May 2014

    Missing Data

    A PSI Training Course on Missing Data Presented by Mike Kenward (GlaxoSmithKline Professor of Biostatistics) and James Roger (Honorary Professor of Biostatistics) Department of Medical Statistics London School of Hygiene and Tropical Medicine
  • 25 Feb 2014

    Practical Interactions for Statisticians

    This course provides an introduction to practical Bayesian analysis in the clinical trial setting. It is aimed at statisticians who are looking for a practical introductory course and who need to be able to conduct Bayesian analyses as part of their day to day work. The course begins with an introduction to Bayesian analyses using problems common in the clinical trial setting and progresses to the use of Bayesian approaches in Dose Response modelling and Meta-Analysis.
  • 04 Feb 2014

    Introduction to Pharmacokinetics & Bioequivalence

    This course serves as an introduction to pharmacokinetics and bioequivalence. It aims to introduce much of the terminology that is used. It will be most suited to Statisticians or Statistical Programmers who have familiarity with clinical trials but have had limited previous experience with designing or analysing trials with pharmacokinetics or bioequivalence objectives. A basic understanding of ANOVA will be assumed.

Journal Club

  • 24 Oct 2019

    The PSI & DIA’s Journal Club: Subgroup Analyses Webinar 24th October 2019, 4pm - 5:00pm (BST)

    Join us in our discussion on Subgroup Analyses at 4pm (BST) on Thursday 24th October.
  • 11 Jul 2019

    The RSS & PSI’s Journal Club: Survival Analysis

    Join us in our discussion on survival analysis method with focus on the application of two Bayesian methods for time to event data at 4pm (BST) on Thursday 11 July.
  • 15 May 2019

    PSI Journal Club: PhD Webinar

    Our next journal club is the inaugural PhD webinar, where we will share 4 topics with you from 4 PhD students. Our format will be slightly changed, with each student presenting for 10 minutes, followed by 5 minutes of discussion.
  • 24 Jan 2019

    PSI Journal Club: Missing Data

    Our next journal club, held jointly with the DIA, features two papers on the topic of Statistical Considerations for Innovative Designs in Clinical Trials. Please join us to hear Jason Yuan and Xiangmin Zhang present their recent work.
  • 11 Dec 2018

    PSI and DIA Journal Club: Statistical Considerations for Innovative Designs in Clinical Trials

    Our next journal club, held jointly with the DIA, features two papers on the topic of Statistical Considerations for Innovative Designs in Clinical Trials. Please join us to hear Jason Yuan and Xiangmin Zhang present their recent work.
  • 24 Sep 2018

    PSI/RSS Journal Club: Meta-Analysis

    Our next journal club, held jointly with the RSS, features two papers on the topic of Meta-Analysis.
  • 12 Jul 2018

    PSI Journal Club Webinar: Bayesian Methods

    Our next journal club features two papers on the topic of Bayesian Methods. Please join us to hear Qingzhao Yu (Louisiana State University) and Margaret Gamalo‐Siebers (Eli Lilly & Co) present their recent work.
  • 26 Apr 2018

    PSI Journal Club Webinar: Modelling and Simulation

  • 12 Jul 2017

    Journal Club - Adaptive Signature Design

    At this joint PSI/RSS journal club webinar, held on 12th July 2017, we heard two excellent presentations on the topic of Adaptive Signature Designs, followed by a fascinating discussion led by Dr Richard Simon, who founded the original methodology.
  • 22 Mar 2017

    Journal Club - Biomarkers

    Our first journal club of the year will featured two papers from Pharmaceutical Statistics on the topic of Biomarkers. The event will be held on Wednesday 22nd March, 15:00 to 16:30 (UK time) For more details please see the journal club homepage.
  • 23 Nov 2016

    Journal Club - Analysing Adverse Event Data

    Our third journal club of the year featured two papers from this summer's Special Interest Issue of Pharmaceutical Statistics on the topic of Analysing Adverse Event Data. Arthur Allignol (Ulm University, Germany) and Tanja Proctor (University of Heidelberg, Germany) presented their work. The event was held on 23rd November, 13:30 (UK time)
  • 06 Jul 2016

    Journal Club - Estimands

    Our second event of the year was a joint event with the RSS on the topic of estimands. The event was held on the 6th July 2016, with speakers Alan Phillips and Peter Diggle presenting their work.
  • 10 Mar 2016

    Journal Club - Poisson/Negative Binomial Modelling

    Our first event of the year was on the topic of Poisson/Negative Binomial Modelling and the different techniques for dealing with missing data. The event took place on March 10th, with speakers Richard Kay and Mouna Akacha presenting their work.
  • 15 Dec 2015

    Journal Club - Decision Rules

    Our last event of 2015, sponsored by Wiley, was held in mid-December 2015, on the topic of Decision Rules. We were pleased to co-ordinate with the DIA again for the last event of the year.
  • 15 Oct 2015

    Journal Club - Missing Data

    Our third event of the year was on the topic of Missing Data. Speakers Oliver Keene and Bohdana Ratitch presented their work published in Pharmaceutical Statistics.
  • 16 Sep 2015

    Journal Club - Simulation and Hypothesis Testing

    Our second event of the year was held in mid-September 2015 on the separate topics of Simulation and Hypothesis Testing. Speakers Andrew Grieve and Anne Benoit presented their work published in Pharmaceutical Statistics.
  • 31 May 2015

    Journal Club - Adaptive Designs

    The first event of 2015 for PSI Pharmaceutical Statistics Journal Club was a joint event with the RSS. The event, sponsored by Wiley and Quintiles, was on adaptive designs and two papers published in Series C of the RSS journal, and Pharmaceutical Statistics, respectively, were presented.
  • 25 Nov 2014

    Journal Club - HTA and Safety Analyses

    Our last event of 2014 was on HTA and Safety analyses. We were please to welcome speakers David Ohlssen and Chrissie Fletcher to discuss their respective papers.
  • 17 Jul 2014

    Journal Club - Hot Topics

    For this "Hot Topics" event, Sara Hughes joined us to discuss data anonymisation, and Kert Viele discussed his work on the use of historical controls.
  • 01 Apr 2014

    Journal Club - Combination Therapies

    Our first event of 2014 was a joint event with the RSS, with speakers Ying Yuan and Michael Sweeting.
  • 12 Dec 2013

    Journal Club - Extreme Value Modelling

    For our final event of 2013 we welcomed Harry Southworth and Janet Heffernan to discuss their two papers on Extreme Value Modelling.
  • 29 Oct 2013

    Journal Club - Sample Size Re-Estimation Techniques

    Daniel Wachtlin and Andrew Jones presented at our joint event with the DIA.
  • 01 Aug 2013

    Journal Club - Papers Chosen by You!!

    Following a survey of the Journal Club audience, the authors of the two papers with the most votes joined us to present their work. Craig Mallinckrodt presented his work on missing data in longitudinal trials and Scott Andersen presented on mixed effects modelling for repeated measures data.
  • 16 Apr 2013

    Journal Club - Survival Analysis

    For our first joint event with the RSS, Abdus Wahed and Nicola Schmitt joined us to present their work on survival analysis.
  • 06 Dec 2012

    Journal Club - Modelling in Drug Development

    For the last event of 2012, Simon Kirby and Kayode Ogungbenro joined us to present their work on modelling in drug development.
  • 27 Sep 2012

    Journal Club - PSI’s Special Interest Groups (SIGs)

    For this special edition, we invited members from the PSI Special Interest Groups (SIGs), to present their work. Helena Geys from the toxicology SIG presented on the statistical methods used in toxicology studies, and Martin Jenkins from the biomarker SIG, presented a statistician's perspective of biomarkers in drug development.
  • 12 Jun 2012

    Journal Club - Decision Making at Interims and DMCs (Joint DIA Event)

    For this joint event with the DIA, Andreas Sashegyi and Sara Hughes presented their work on decision making at interims and DMCs.
  • 18 Apr 2012

    Journal Club - Meta-Analyses in Clinical Trials

    Speakers Steven Julious and Christy Chuang-Stein joined us to present their work on meta-analyses.
  • 13 Dec 2011

    Journal Club - Publications from the Pharmaceutical Industry

    James Matcham and Michael O'Kelly joined us to discuss reporting and publication in the pharmaceutical industry.
  • 21 Jul 2011

    Journal Club - Early Phase Clinical Trials

    Timothy Montague and Ileana Baldi joined us present their work on early phase clinical trials.
  • 05 Apr 2011

    Journal Club - Multiregional Trials (Joint DIA Event)

    For our joint event with the DIA, Paul Gallo presented his work on the consistency of treatment effects in multiregional trials, and James Hung presented on some of the considerations needed in the design and analysis of multi-regional trials.
  • 27 Oct 2010

    Journal Club - Survival Analysis

    Richard Kay joined us to present on assessing evaluation time bias, and Gui-shuang Ying presented on prediction of event times via the Weibull distribution.
  • 10 Jun 2010

    Journal Club - Missing Data

    Alan Phillips and Mohamed Alosh presented their recently published work on missing data.
  • 24 Mar 2010

    Journal Club - Bayesian Methods

    Richard Nixon presented a case study utilising simulations for a Bayesian rheumatoid arthritis trial, and Les Huson joined us to present on Bayesian methodology for a logistic dose-response curve.
  • 01 Dec 2009

    Journal Club Launch

    For our launch, John Whitehead presented his paper, "Action following the discovery of a global association between the whole genome and adverse event risk in a clinical drug-development programme", and Kevin Carroll presented on sample size ("Back to basics: explaining sample size in outcome trials, are statisticians doing a thorough job?").

Webinars

  • 03 Dec 2019

    PSI Webinar - Overview and awareness about quantitative decision-making in drug development

    Quantitative methods to support decision-making in clinical drug development already exist, but may be unknown or unused by pharmaceutical companies.
  • 18 Nov 2019

    PSI Scientific Committee Webinar - Longitudinal modelling: Time to take the next step?

    Longitudinal data, i.e. data that arises from repeated observations of the variable over a period of time, has long been put forward as one way to improve to the efficiency of drug development. However, even though there is a rich statistical methodology for longitudinal data, there is no full, wholehearted uptake of these methods in pharmaceutical statistics..
  • 15 Oct 2019

    PSI Scientific Committee Webinar: Statistical Challenges in Analytical Comparability and Biosimilarity Assessment

  • 02 Oct 2019

    PSI Webinar: Effective Insight Communication

  • 04 Jul 2019

    PSI Webinar: Adaptive design: updated draft FDA guidance and its implications

    In September 2018 the FDA published a guidance on adaptive design for clinical trials of drugs and biologics, updating (not finalizing) its initial draft from February 2010. The main focus of the webinar will be to provide an overview of its main contents, which will be presented by Jürgen Hummel (PPD). In addition, Kaspar Rufibach (Roche) will introduce an open-source statistical software for adaptive designs, RPACT (an R package that enables the design and analysis of confirmatory adaptive clinical trials). Kit Roes will also comment on the guidance from a European Regulatory perspective, which will be followed by a brief panel discussion.
  • 18 Jun 2019

    PSI Toxicology SIG Webinar "Pig-A Assay":

    The in vivo Pig-a gene mutation assay is based on the endogenous X-linked Pig-a gene (phosphatidylinositol N-acetylglucosaminyltransferase, subunit A).
  • 08 May 2019

    Webinar: MCP-Mod – Theory, Implementation and Extensions

    MCP-Mod (Multiple Comparisons & Modelling) is a popular statistical methodology for model-based design and analysis of dose finding studies. This webinar will describe the theory behind MCP-Mod (plus extensions), and how to implement it within available software. Pantelis Vlachos (Cytel) will provide a brief introduction to the methodology and illustrate the MCP-MoD capabilities in EAST 6.5. Saswati Saha (Inserm, Aix-Marseille University) will discuss new variations and alternatives to MCP-Mod and show how to implement them in R. Neal Thomas (Pfizer) will present further technical details of MCP-Mod by evaluating the method using results from least squares linear model theory.
  • 12 Mar 2019

    PSI Webinar: Statistical Engagement with Commercial Activities

  • 19 Feb 2019

    PSI Toxicology SIG Webinar - Data Quality and Reproducibility in Preclinical Research

    Malcolm Macleod will discuss issues of research waste; of replication; and of how these issues might be harnessed to improve research.
  • 21 Jan 2019

    PSI Webinar: HTA Submissions in the UK

    There is a simple equation for access in the UK: Access = Reimbursement + Uptake. Yet, whilst a simple and logical approach, each component is challenging to achieve. This webinar focuses on the National Reimbursement side: the National Institute for Health and Care Excellence (NICE) - who they are, what is involved in the Health Technology Appraisal (HTA) assessment, how they make decisions.
  • 19 Dec 2018

    PSI Webinar: How to use prior knowledge and still give new data a chance?

    The paper to be presented appeared earlier this year in Pharmaceutical Statistics (Weber, Hemmings, Koch, 17, 329-341) and is motivated by the opportunities and challenges for using Bayesian methods with informative priors to support drug development and licencing when only a small pool of patients is available, as in the case of rare diseases and paediatric population.
  • 11 Dec 2018

    How Well do Toxicology Studies Predict Clinical Safety Outcome? – A Translational Safety Big Data Analysis

    Published in: Regulatory Toxicology and Pharmacology 96 (2018) 94–105; https://doi.org/10.1016/j.yrtph.2018.04.018)
  • 29 Nov 2018

    PSI Webinar: Avoiding Pitfalls in Supervised/Unsupervised Learning

    As the availability of big data increases and statisticians assist with predicting outcomes or understanding patterns in an ever-wider variety of scenarios then supervised and unsupervised learning methods become increasing called upon. Such machine learning algorithms offer the opportunity to understand potential predictors or clusters amongst large datasets, but are also subject to the risks of overfitting or over-interpretation. This Webinar seeks to introduce ideas and share experiences in this field.
  • 20 Nov 2018

    EFSPI/PSI Webinar: Do you understand the patient point of view on benefit-risk tradeoffs? Introduction and case studies of stated preference elicitation methods

    This webinar proposes a short primer on stated preference methods and how they can be used to explore the patient preferences for specific drug profiles that are currently available or may be developed in the near future. The theory will be then discussed as applied to two case studies using quantitative preference methods.
  • 18 Sep 2018

    PSI Toxicology SIG Webinar: Strengths, Weaknesses, Opportunities and Threats to the Pre-Clinical Statistician

  • 19 Jun 2018

    PSI Toxicology SIG Webinar

    Ludwig A. Hothorn will be presenting on recent developments of statistics in toxicology - using R.
  • 08 May 2018

    PSI Webinar: Patient Reported Outcomes (PROs) - Clinically Meaningful Interpretation

  • 18 Apr 2018

    PSI Webinar: Basket, Umbrella and Platform trials - Experiences and practical considerations

  • 17 Apr 2018

    PSI Toxicology SIG Webinar

  • 22 Mar 2018

    PSI Webinar: What’s the big deal with big data and will it have a big impact on me?

  • 13 Mar 2018

    PSI/EFSPI Webinar: Quantitative benefit-risk assessment using MultiCriteria Decision Analysis (MCDA) and its extensions: practical application

  • 06 Mar 2018

    PSI Webinar: HTA submissions in Germany, what do statisticians need to know to be successful with their GBA dossiers – Part Three

  • 20 Feb 2018

    PSI Webinar: Integrating transcriptomics into early safety screening

  • 31 Jan 2018

    PSI Webinar: HTA submissions in Germany, what do statisticians need to know to be successful with their GBA dossiers – Part Two

  • 23 Jan 2018

    PSI Webinar: HTA submissions in Germany, what do statisticians need to know to be successful with their GBA dossiers – Part One

  • 12 Dec 2017

    PSI Toxicology SIG Webinar

    This talk introduces a procedure to choose an optimal sparse sampling scheme and sampling time points using non-compartmental methods but which can be applied to further settings beyond this. We discuss how robust designs can be obtained and we apply and evaluate the approach to a range of scenarios to give an example of how it may be implemented.
  • 17 Nov 2017

    EFSPI/PSI Webinar: Anonymising Clinical Data

    The intent of this webinar is to describe what is involved in anonymising clinical data, and present the different methods and approaches available for anonymisation including an introduction to residual risk assessment.
  • 02 Nov 2017

    PSI Webinar: Causal Inference

  • 30 Oct 2017

    EFPSI/EFPIA Webinar: New draft ICH E9 addendum on Estimands and Sensitivity Analysis

  • 24 Oct 2017

    PSI Webinar: Patient Preferences – a webinar with Kevin Marsh presented by the Benefit-Risk SIG

  • 28 Sep 2017

    EFSPI/PSI Webinar: Spotlight on the Integrated Data Analysis SIG

    EFSPI together with PSI will organise a webinar on September 28th on Spotlight on the Integrated Data Analysis SIG
  • 26 Sep 2017

    PSI Webinar: Measuring Patient and Physician Benefit–Risk Preferences in Antipsychotic Clinical Trials

  • 19 Sep 2017

    PSI Webinar: Statistics and the Ames Test

    The bacterial reverse mutation assay (or the Ames test) has been in use in its present form for over 40 years. It is arguably the most successful in vitro test, used by hundreds of laboratories worldwide, on thousands of substances. The test aims to identify substances that can produce genetic damage and may lead to cancer in exposed individuals or to inherited mutation in offspring to cancer.
  • 12 Jul 2017

    Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle: PREFER – an IMI Project

    In our 1-hour webinar on the 12 of July 2017 (4:30pm CET, 3:30pm BST, 10:30am EST) we will have a presentation by Conny Berlin and Rachael DiSantostefano
  • 21 Jun 2017

    PSI Webinar: Data Sharing and Data Privacy - what every statistician needs to know

    The intent of this webinar is to provide an outline to pharmaceutical statisticians of key issues and concepts everyone dealing with and sharing patient level data should be aware of.
  • 13 Jun 2017

    Patient Engagement in Clinical Trials Webinar

    Following on from the successful and thought-provoking presentation at last year’s PSI conference by Paul Wicks from PatientsLikeMe, this webinar will continue to explore the ways in which patients are influencing the design of new clinical trials.
  • 04 May 2017

    Personalised Medicine: Statistics for Companion Diagnostics

    This webinar will introduce and examine some of the considerations required for statisticians working in the field of companion diagnostics and will include information from an FDA (CDRH) speaker and perspectives/ case-studies from representatives from both a pharmaceutical company and a diagnostic company.
  • 09 Feb 2017

    Structured Benefit–Risk Assessment Webinar

    Please join our webinar. We'll have 2 presentations from widely known speakers: The emerging and merging fields of benefit-risk and health technology assessments. The webinar occurs twice - please register for one of the following dates: 1st webinar: 2017 February 9, 5pm CET (4pm GMT) 2nd webinar: 2017 February 14, 5pm CET (4pm GMT)
  • 16 Nov 2016

    PSI Scientific Committee Webinar: Rare Diseases: Regulatory and Study Design Considerations

    Registration is free to attend! Talks from John Scott (Deputy Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research) and Lisa Hampson (Lecturer in Statistics at Lancaster University)
  • 15 Sep 2016

    Second Membership Town Hall: PSI/RSS merger

    Calling all PSI members to register for the upcoming debate regarding the proposed PSI/RSS merger. Hear the arguments for and against the proposal and have the opportunity to ask questions of representatives for each campaign and the RSS.
  • 12 Jul 2016

    Membership Town Hall: PSI/RSS merger

  • 09 May 2016

    PSI Scientific Committee Webinar: Surrogate Endpoints

  • 05 Feb 2016

    Discussion on the Potential Merger With The Royal Statistical Society

    The BoD is in discussions with the Royal Statistical Society about a possible union.
  • 01 Feb 2016

    Discussion on the Potential Merger With The Royal Statistical Society

    The BoD is in discussions with the Royal Statistical Society about a possible union.
  • 16 Jul 2015

    PSI Webinar: Drug Development Beyond the FDA/EMA

    Clinical drug development has often had a heavy focus on the needs of the FDA and EMEA. This webinar aims to focus on the needs of the China FDA (cFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) providing both insights into the regulatory requirements, real life examples of local development plans and key things to consider when looking to include these countries in multi-regional trials.
  • 18 Jun 2015

    PSI Scientific Committee Webinar: Drug Development beyond the FDA/EMA – Opportunities and Challenges in Asia Pacific Development Pathways

    The webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link. Clinical drug development has often had a heavy focus on the needs of the FDA and EMEA. This webinar aims to focus on the needs of the China FDA (cFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) providing both insights into the regulatory requirements, real life examples of local development plans and key things to consider when looking to include these countries in multi-regional trials.
  • 16 Oct 2014

    Heart Failure Trials and Recurrent Events

    PSI Scientific Committee Webinar: Heart Failure Trials: Novel Estimands and Methodologies to Evaluate Therapies based on the Totality of Evidence
  • 11 Mar 2014

    Trials and Errors in Clinical Trials

    This webinar aims to take a practical approach to some of the trials and errors seen in Clinical Trials. The webinar will go through some real life examples of where trials and statistical analyses may not have gone as expected! As well as covering some of the errors often seen by the MHRA whilst reviewing submissions

Careers Meetings

  • 05 Nov 2019

    Maths Meets Medicine 2019

    The Careers and Academic Liaison Committee (CALC) will be hosting their fourth Maths Meets Medicine event this year at the University of Reading. The event provides the opportunity for KS4 students to come and learn about how...
  • 05 Nov 2018

    Maths Meets Medicine 2018

    The Careers and Academic Liaison Committee (CALC) will be hosting their third Maths Meets Medicine event this year at the University of Reading.
  • 12 Oct 2018

    Bucks Skills Show 2018

    The Bucks Skills Show 2018 is an event for young people to explore careers, discover different industry sectors and work out how to achieve their ambitions.
  • 28 Feb 2018

    Medical Statistics Taster Day 2018

    Our annual careers event, Medical Statistics Taster Day, will be held at the University of Leicester on Wednesday 28th February 2018.
  • 30 Jun 2017

    YSS Statistical Showcase 2017

    This year's event will be held on Friday 30th June, 10am - 7pm, near to the RSS headquarters in Erroll Street, London.
  • 16 Mar 2017

    Schools Event 2017: Maths Meets Medicine, Bath

    Students aged 14-15 will be selected from schools in the regions close to the events to take part in a number of interactive and fun statistics-related workshops, which aim to complement and extend the statistics concepts being taught at KS4 and KS5 levels.
  • 13 Mar 2017

    Schools Event 2017: Maths Meets Medicine, Guildford

    Students aged 14-15 will be selected from schools in the regions close to the events to take part in a number of interactive and fun statistics-related workshops, which aim to complement and extend the statistics concepts being taught at KS4 and KS5 levels.
  • 22 Feb 2017

    PSI Careers Event 2017

    The next PSI Careers Event will be held at the University of Reading on Wednesday 22nd February 2017. MSc students, as well as final year BSc and PhD students will be invited to attend.
  • 01 Jun 2016

    Schools Event 2016

    The Careers and Academic Liaison Committee (CALC) are planning a Schools Event, to be hosted at the University of Reading summer 2016. Date to be confirmed
  • 25 May 2016

    Updated: Berlin Careers Seminar

    As part of the PSI conference in Berlin this year, we will be hosting an interactive careers seminar for students local to the Berlin area.
  • 18 Apr 2016

    SMi’s 8th Annual Adaptive Designs in Clinical Trials

    The event is designed to highlight an array of topics, including adaptive designs within the context of a development programme, Bayesian analysis in adaptive design, biomarker-driven trials, opportunities of adaptive enrichment designs in the era of precision medicine, and much more!
  • 03 Feb 2016

    Careers Fair 2016

    The Careers and Academic Liaison Committee (CALC) are planning the annual Careers Fair Event on Wednesday 3rd February 2016, to be hosted at the University of Reading.
  • 19 Feb 2014

    Success at the PSI Careers Event 2014

    On the 19th February 2014, CALC ran the fourth annual PSI careers event. Fifteen different companies and organisations descended on the University of Sheffield, along with approximately 90 BSc, MSc and PhD students from across the country for a half-day event which consisted of a mix of presentations, newly created workshops, and time for the students to talk to the different companies.

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