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Bethesda North Marriott Hotel and Conference Center

Feb 11, 2019 7:00 PM - Feb 13, 2019 8:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Session 10: Track 1: It Takes a Village - Aka the IRISS Forum

Session Chair(s)

Brooke  Casselberry, MS, RAC

Brooke Casselberry, MS, RAC

Vice President, Advisory and Delivery

Epista Life Sciences, United States

Change continues to happen with the implementation of regulatory information submission standards across the globe. Are the processes at your company currently regarding existing standards? Do you know what new standards are on the horizon? Within your company, are you planning and making changes to meet these new standards? Members of the IRISS Forum regularly discuss these types of questions. Using a global sounding board of expert advice and experience from peer-based IRISS topic groups, discussions focus on ways to achieve successful regulatory applications and proactively address issues with the implementation of standards.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Summarize the purpose of the IRISS Forum and opportunities it offers for involvement
  • Identify the benefits of the IRISS CMC Book of Knowledge and how it can be used to benefit organizations
  • Recognize the important role the IRISS IDMP Topic group has played and continues to play in providing guidance in organizational IDMP journeys
  • Speaker(s)

    Sue  Metz

    How far the Village has Come in 10 Quick Years

    Sue Metz

    IRISS Forum, United States

    President/CEO

    Marie  Parrish, PhD, MS

    CMC Books of Knowledge

    Marie Parrish, PhD, MS

    SPARC, United States

    Frits  Stulp, MSc

    Role of IRISS IDMP Topic Group in SPOR and IDMP Developments

    Frits Stulp, MSc

    Deloitte, Netherlands

    Life Sciences & Healthcare Industry Leader for the Netherlands

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