RBQM Ops 2022 - What do the regulatory authorities really want to see?

What do the regulatory authorities really want to see?

DUNCAN HALL

Now our next speaker is someone I've had the pleasure of knowing and collaborating with more than 10 years now, I'm delighted to announce Linda Sullivan, who's a Senior Advisor for metrics and performance management at WCG. I first met Linda in the early days of the Metrics Champion Consortium, an industry body she founded and served as Executive Director of until their recent acquisition. Now, Linda has always cared about collaboration and education and has managed to navigate the many different views and opinions of Sponsors, CROs, and Vendors alike, and always find the common ground needed to deliver valuable assets as an end result of her analysis and investigations. She's a prominent speaker, writer, and blogger, and has had many published articles in leading journals, and has served on a number of industry advisory boards. Recently, Linda has been working with regulatory authorities on risk assessment inspection findings, so there's no one better placed to talk on this next topic, what the regulatory authorities really want to see. Linda is a pleasure to have you here. Welcome and over to you.

LINDA SULLIVAN

Thank you for the kind introduction, Duncan, it's a pleasure to be here. As the disclaimer states, these are my opinions and not those of my employer or TRI.

When TRI asked me to come and talk about what regulatory authorities really want to see, I thought about it in two ways. The first is a question that I hear frequently, what does good look like? And the second is one that people are concerned about in terms of what are inspectors actually looking for, have they transitioned over and are looking for the RBQM approach as described in the guidance documents? To answer the question, I think we need to think about the regulatory update to inspection findings cycle. We have some examples of RBQM, QBD types of guidances that have been released. And it takes a bit of time for sponsors and vendors to interpret the guidances implement some pilots and then full-blown programs, and for those studies to go through the submission process, and for us to have inspection findings to review. And the question is, have we reached the point in the cycle where we actually have inspection findings? So, let's take a quick look at maybe what we can find out about the FDA and the MHRA...