Under EMA Policy 70 Publication of Clinical Data, clinical overviews and study reports submitted as part of a Marketing Authorisation Application are published and made publically available. Before documents are published, sponsors need to anonymise the documents aligned to data privacy requirements.
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. Examples from the PhUSE Data De-Identification Standard will also be discussed.
Jean-Marc Ferran (Qualiance / PhUSE) will present ‘Anonymising Clinical Data – key principles, methods and considerations’. Chrissie Fletcher will facilitate a Q&A session.
Under EMA Policy 70 Publication of Clinical Data, clinical overviews and study reports submitted as part of a Marketing Authorisation Application are published and made publically available. Before documents are published, sponsors need to anonymise the documents aligned to data privacy requirements.
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. Examples from the PhUSE Data De-Identification Standard will also be discussed.
Jean-Marc Ferran (Qualiance / PhUSE) will present ‘Anonymising Clinical Data – key principles, methods and considerations’. Chrissie Fletcher will facilitate a Q&A session.
Under EMA Policy 70 Publication of Clinical Data, clinical overviews and study reports submitted as part of a Marketing Authorisation Application are published and made publically available. Before documents are published, sponsors need to anonymise the documents aligned to data privacy requirements.
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. Examples from the PhUSE Data De-Identification Standard will also be discussed.
Jean-Marc Ferran (Qualiance / PhUSE) will present ‘Anonymising Clinical Data – key principles, methods and considerations’. Chrissie Fletcher will facilitate a Q&A session.
Under EMA Policy 70 Publication of Clinical Data, clinical overviews and study reports submitted as part of a Marketing Authorisation Application are published and made publically available. Before documents are published, sponsors need to anonymise the documents aligned to data privacy requirements.
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. Examples from the PhUSE Data De-Identification Standard will also be discussed.
Jean-Marc Ferran (Qualiance / PhUSE) will present ‘Anonymising Clinical Data – key principles, methods and considerations’. Chrissie Fletcher will facilitate a Q&A session.
Under EMA Policy 70 Publication of Clinical Data, clinical overviews and study reports submitted as part of a Marketing Authorisation Application are published and made publically available. Before documents are published, sponsors need to anonymise the documents aligned to data privacy requirements.
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. Examples from the PhUSE Data De-Identification Standard will also be discussed.
Jean-Marc Ferran (Qualiance / PhUSE) will present ‘Anonymising Clinical Data – key principles, methods and considerations’. Chrissie Fletcher will facilitate a Q&A session.
Under EMA Policy 70 Publication of Clinical Data, clinical overviews and study reports submitted as part of a Marketing Authorisation Application are published and made publically available. Before documents are published, sponsors need to anonymise the documents aligned to data privacy requirements.
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. Examples from the PhUSE Data De-Identification Standard will also be discussed.
Jean-Marc Ferran (Qualiance / PhUSE) will present ‘Anonymising Clinical Data – key principles, methods and considerations’. Chrissie Fletcher will facilitate a Q&A session.
Date: Ongoing 6 month cycle beginning late April/early May 2024
Are you a member of PSI looking to further your career or help develop others - why not sign up to the PSI Mentoring scheme? You can expand your network, improve your leadership skills and learn from more senior colleagues in the industry.
PSI Training Course: Mixed Models and Repeated Measures
This course is presented through lectures and practical sessions using SAS code. It is suitable for statisticians working on clinical trials, who already have a good understanding of linear and generalised linear models.
Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This is an interactive online training workshop providing an in-depth review of the estimand framework as laid out by ICH E9(R1) addendum with inputs from estimand experts, case studies, quizzes and opportunity for discussions. You will develop an estimand in a therapeutic area of interest to your company. In an online break-out room, you will join a series of team discussions to implement the estimand framework in a case study, aligning estimands, design, conduct, analysis, (assumptions + sensitivity analyses) to the clinical objective and therapeutic setting.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.