Comment Now! FDA Releases Draft Guidance E8 Revision
08/06/2019
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The Food and Drug Administration (FDA) announced the availability of the draft guidance “E8(R1) General Considerations for Clinical Studies” for public comment. The purpose of the draft guidance is to increase flexibility of clinical trials while improving the quality of clinical trial data presented to regulatory authorities. The draft guidance originates from the International Council for Harmonisation’s (ICH) E8 draft revision. The revision is part of ICH’s Good Clinical Practice (GCP) Renovation initiative, which outlines plans to revise ICH E8 and further revise ICH E6.
Live Webinar Identifying Workforce Gaps in RBM: August 13
7/30/2019
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Topic: Identifying Workforce Gaps Post Risk-Based Monitoring (RBM): It’s Time to “DIG” in!
Date: August 13, 2019
Time: 1:00 p.m. – 2:00 p.m. EDT
Duration: 60 minutes
Sponsored by: Life Science Training Institute
Webinar: Live interactive session. Recording will be available for 30 days.
Sign up here.
Introducing the DIGR-ACT® Solution! Part 7
7/23/2019
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What does ‘T’ stand for?
Everyone talks about learning from when things go wrong. People say it's the best way to learn. But it's not always easy. The DIGR-ACT® solution gives you a way. By taking you through the issue to the root cause, actions and then making sure the actions work, you have learned from the issue. Maybe your learning can be transferred to others? Perhaps the same problem happens to other people too?
Introducing the DIGR-ACT® Solution! Part 6
7/09/2019
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What does ‘C’ stand for?
Do you care whether the actions you took to try to stop an issue from recurring were completed? Does it matter if they actually worked? Of course! Deciding on actions is only part way to fixing a problem. We need to complete the actions and make sure they were effective. That's why there is the ‘C’ step in the DIGR-ACT® solution, where C stands for ‘Check’.