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Starting up SIG

Starting up SIG. Develop charter Ask for input EFSPI (Council, Statistics Leaders Meeting) Identify other stakeholders, ask input Announce via Newsletter EFSPI Introduce SIG Ask for participants, explain expectations with as starting point:

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Starting up SIG

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  1. Starting up SIG • Develop charter • Ask for input EFSPI (Council, Statistics Leaders Meeting) • Identify other stakeholders, ask input • Announce via Newsletter EFSPI • Introduce SIG • Ask for participants, explain expectations with as starting point: • All of the SIGs welcome new members at any time, and individuals who may be interested to join a SIG do not need to be an expert in the topic area(s).  Individuals who are motivated to learn about a topic and are keen to actively engage and collaborate with colleagues are very welcome to join a SIG.  • Use website EFSPI for information exchange • Develop presentation for home page (see other SIG pages) • Use Public area and Private area at SIGs discretion

  2. Charter SIG Contents: • Background/Rationale • Goals/Objectives/Scope: • See for generic version separate slide • Organization • Membership • Name, company, e-mail address • Meetings • E.g., t-con/web-ex; monthly 1 hour; Minutes taking • Information sharing • Website EFSPI • Communication Plan • Newsletter (PSI, EFSPI) • Stakeholders identification • Collaborations

  3. Possible wordings for Objectives SIG Objectives (template): • To create a forum for individuals interested in < > to share experiences, develop best practices, work with experts in the field and collaborate with other interested parties on < > in drug development. • To be aware of regulatory initiatives of relevance to <> and to assess their potential impact on industry practice. • To develop an industry position on < > • To form working groups to review current methodology and practice, and where necessary develop new methods or practices for the integration of data, in the areas of: • … • To write position papers on the topics identified and engage in public debate by making presentations at public meetings and conferences. • 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 < > • Keep abreast of new research and methodological developments; • Promote and highlight opportunities for statisticians to make a positive impact in < > • Interact with key opinion leaders in < > • Organise and/or participate in workshops related to < >

  4. EFSPI website • https://www.efspi.org/ • SIGs is one of the tabs

  5. EFSPI website • http://www.efspi.org/ • SIGs have their own pages • Introduction page • Public area • Private area • Webmaster • Chrissie Fletcher • fletcher@amgen.com

  6. Back up slides EXAMPLE 6

  7. Back up slides 7

  8. SIGs present themselves • In 2014 EFSPI Newsletters all SIGs at the time have presented themselves • See collection attached for examples

  9. SIG – Statistics Leaders mtg • Most of the SIGs have been invited to the Statistics Leaders Meetings to present themselves and to discuss strategic and directional input

  10. SIG – EFSPI / PSI • Contact person to SIGs for EFSPI Council • Maylis Coste & Anne Danniau • maylis.coste@servier.com • anne.danniau@grunenthal.com • Contact person to SIGs for PSI Board • Adam Crisp • adam.x.crisp@gsk.com

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