RBQM Ops 2022 - Day 1 Panel Session

Panel Session Day 1 RBQM Ops 2022

SUMMARY KEYWORDS
risk assessment, quality, people, rbqm, monitoring, study, data, patient, risk, sponsors, site, question, approach, piece, regulators, fda, process,

SPEAKERS
Duncan Hall, Linda Sullivan, Esther Huffman-O’Keefe Karen McCarthy Shau, Ingrid Oakley-Girvan

DUNCAN HALL:

I hope everyone's had a great day today and enjoyed the sessions that we've been running on all afternoon today. Special thank you, for Ingrid, Esther, and Linda, who have all been presented today as well. And also very, very generously volunteered their time for the panel session as well. Karen's the only person today who has not been already introduced. So I'll introduce Karen, who works for vertex in the RBQM group that that we saw, saw presented today by Deepa. So, Karen did an Ironman and actually decided that she would delegate her responsibilities for presenting today saw the risk and dealt with it. And so she delegates it down to Deepa.

So Thank you, Karen, for joining us today. Linda, Esther, Ingrid, thank you for your fantastic presentations as well today. Esther, I have to give you kudos for, for getting both Eyore and Ironman into a presentation on RBQM, kind of both ends of the entertainment spectrum covered there, but really, really appreciated that. So we're going to be just running through some Q&A, pretty much based on the presentation that we've seen today, and just some of the general questions that we've been getting in the build up to this event. So, we'll be running through those.

And then we're going to do a little pause about halfway through and do a quick poll. Just to get some basic intelligence from the from the listeners today as well, which is always great just to hear kind of how people are thinking and feeling at the moment as well. So welcome, Linda. Welcome, Karen. Welcome, Esther. Welcome. Ingrid, great to have you here.

I'm going to kick off Linda I’d like to, sort of focus a little bit just on some of the pieces you were talking around in your presentation about the regulators. And you talked a little bit about what the regulators are looking for some of the insights that you've had from recent conferences and conversations. Really wanted to get your view on what role you think the regulatory authorities should be taking and really driving RBQM adoption, it's clearly there, in regulatory guidance. And again, these questions are open to everybody, but you've given Linda, you were talking about that. Do you think that the regulatory authorities should be doing more to drive adoption? Or is the fact that we have regulatory guidance enough?

LINDA SULLIVAN
Well, I think, you know, one of the things that was so interesting that happened at the DIA meeting in May, was we finally had somebody presenting findings from inspections that were related to, you know, QBD and RBQM. And, you know, you could have heard a pin drop in that room, everyone was about to jump out of their chair like, oh, my gosh, here it is. And I think we need more of that. Because in the beginning, there was a lot of concern that the inspectors might still be inspecting for the old stuff.

And, you know, there was a bit of a disconnect early on, when, you know, FDA issued the RBQM guidance.