Human Factors Discussion - Summary
Thank you to Bjorg Hunter (GSK) and her industry colleagues for providing the summary of discussions that occurred during the Xavier Combination Products Summit September 12-14, 2018 related to Human Factors (HF) Protocol submission in line with the draft regulatory guidance: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development, section IV.C. After the summit, a group of industry and FDA members continued the discussion on additional topics, which is summarized within the document as well.
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2019 Xavier Combination Products Summit
Don’t forget to join us for the 2019 Xavier Combination Products Summit coming very soon: September 11-13, 2019 with a workshop and Office Hours with FDA’s Thinh Nguyen and Barr Weiner occurring on the 11th.