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Risk-Based Quality Management: Who Should Be in the Room and When While Assessing Risks During a Clinical Trial?

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References

  1. “Brief Survey on RBQM and You,” DIA GCP-QA RBQM Survey Link: https://forms.gle/d6pYgzqaUanFnVpr9

  2. International Council for Harmonisation, ICH E6(R2). 2016. https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf. Accessed 21 Aug 2022.

  3. International Council for Harmonisation, ICH E8(R1). 2021. https://database.ich.org/sites/default/files/ICH_E8-R1_Guideline_Step4_2021_1006.pdf. Accessed 21 Aug 2022.

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Acknowledgements

The authors thank other members of the DIA GCP-QA RBQM Working Group who were provided with the Content Hub slides for comments prior to the meeting presentation: Paula Horowitz, Richard M. Siconolfi, Sandy Mohan, and Nimita Limaye.

Funding

No funding supported this research.

Author information

Authors and Affiliations

  1. Daiichi Sankyo, Inc., 211 Mount Airy Road, Basking Ridge, NJ, 07920, USA

    Terry Katz MS

  2. Contego Medical, Raleigh, NC, USA

    Maryrose Petrizzo

  3. KAN Consulting, Athens, Greece

    Kamila Novak

  4. Tigermed, Gaithersburg, MD, USA

    Munish Mehra

Authors
  1. Terry Katz MS
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  2. Maryrose Petrizzo
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  3. Kamila Novak
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  4. Munish Mehra
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Contributions

TK, MP, KN, and MM contributed to the concept and DIA Meeting Content Hub Abstract. MM was the author and administrator of the survey. KN created the survey posts on LinkedIn. TK and MP were the presenters at the DIA Meeting Content Hub. All four authors contributed to the manuscript development, review, copy editing, and finalization.

Corresponding author

Correspondence to Terry Katz MS.

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The Authors declare that they have no conflicts of interest.

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Katz, T., Petrizzo, M., Novak, K. et al. Risk-Based Quality Management: Who Should Be in the Room and When While Assessing Risks During a Clinical Trial?. Ther Innov Regul Sci 58, 18–20 (2024). https://doi.org/10.1007/s43441-023-00591-5

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  • DOI: https://doi.org/10.1007/s43441-023-00591-5

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