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Quality Risk Management

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Chairperson. Peter Schiemann, Widler & Schiemann Ltd

Mission. To engage stakeholders from regulatory and other governmental agencies, industry, non-governmental local and international agencies and organizations, and academia to accomplish the following:

  • Provide a professional forum for discussing issues and sharing information related to application of QRM principles throughout the product life cycle;
  • Publicize the QRM field worldwide to stimulate members in ICH and non-ICH regions to apply QRM principles in regulated and unregulated areas of the product life cycle (i.e. drug development through commercial operation and product discontinuation);
  • Create, publish, and promote materials on QRM-related issues and topics and on QRM professional development opportunities; and
  • Identify and address the educational needs of DIA members who are interested in applying QRM.

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Media PlayerInstant Download! New Guidances on Quality Risk Management by FDA and EMA: Implications for Industry

This audiosynchronized presentation explores how the recent FDA and EMA Guidances and Clinical Trial Transformation Initiative (CTTI) will influence how clinical studies are designed and conducted in the future.

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