Real World Data

The Real World Data SIG (formerly Epidemiology and Drug Safety SIG) has now been in operation since 2008 and continues to provide a forum for discussing statistical issues relating to Real World Data and Drug Safety across the pharmaceutical industry. Our objective is to discuss methodological aspects related to real world evidence generation and form a consensus on the best statistical practice in various areas of Pharmaco-epidemiology and Drug Safety.

Purpose

The purpose of the Real World Data Special Interest Group (RWD SIG) is to provide statisticians working in the Pharmaceutical Industry engaged in Real World Data Analysis, and others in related fields of research, an opportunity to:

  • Maintaining a strong alliance within the "statistics community" to respond to industry-wide issues regarding RWD and Drug safety
  • Collaborate and discuss strategies and methodology being applied in this area of research
  • Exchange information and share case studies and statistical/analytical challenges faced in RWD research
  • Keep abreast of new research and methodological developments
  • Promote and highlight opportunities for statisticians to make a positive impact in RWD
  • Interact with key opinion leaders in RWD research
  • Organize and/or participate in workshops related to RWD.

Steering committee:

The RWD SIG Steering Team consists of 7 members:

 

Name

Company

Dr George Quartey

Genentech (Chair)

Dr Maurille Feudjo-Tepie

Amgen

Dr Joseph Kim

IMS Health

Dr Jixian Wang

Celgene

Nilani liyanage

Ipsen

Dr Jonathan Alsop

Numerus Ltd

Arlene Gallagher

MHRA

In addition to the Steering Committee the RWD SIG mailing list contains over 100 other individuals (both PSI/EFSPI members and non-members) who have been involved in SIG events or have requested to be included on email updates sharing SIG events and relevant related materials that may be of interest. If you would like to be added to our affiliate’s mailing list, please email Dr George Quartey (quarteyg@gene.com), or go to the SIG area on the PSI or EFSPI website.

Latest News

The RWD SIG spent a great deal of time collaborating and sharing experiences of RWD and Safety research.

Plans for 2014 include:

  • New RWD Analytics Handbook for Statisticians ( due Q3 2014)
  • One-Day Scientific Meeting on “Post Authorization Safety and Effectiveness Studies: Regulatory-Industry Perspectives and Challenges”at Amgen Uxbridge planned for 21st October 2014.

Key topics to be discussed include:

  • Recent Changes in EU Legislations: PASS and PAES (Dr Andrew Thompson-MHRA)
  • PASS and PAES Process: Who are reviewers, What is their perspective and How it is organized, how do they react to Practical challenges such as market penetration issues etc. (Dr Jim Slattery-EMA)
  • Some reflections on how industry can organize themselves to rise to these new demands–[Dr Andrew Roddam (GSK) and Dr Jamie Robinson (Roche)].
  • Methodological Challenges in conducting PASS/PAES effectively [Dr Maurille Feudjo-Tepie (Amgen)]
  • PAES/PASS data Opportunities and Challenges and How the CPRD can optimally be used to answer some of these questions/requests[ (Arlene Galagher-MHRA)]

 

Latest News


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EventsFuture Events


  • PSI Toxicology SIG Workshop 2018 - Dates: 24 – 25 Apr, 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.
  • PSI Toxicology SIG Webinar - Dates: 12 – 12 Dec, 2017

    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.
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