MHRA’s Developing Impact on Transparency: An Interview With Nirpal Virdee

Narrator: This is the DarshanTalks Podcast. Regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on Twitter @DarshanTalks or the show's website at darshantalks.com. Darshan: Hey everyone. Welcome to another episode of DarshanTalks. We have a regular guest with us, Nirpal Virdee, and, Nirpal, as you guys have heard from his accent is from the UK and was going to talk to us a little bit about Brexit. We've had a couple of talks before, but Brexit is ever-changing and constantly evolving. And, Nirpal's going to talk to us a little bit about that and how it's going to impact the life sciences. So welcome, Nirpal. Tell us a little bit about yourself first. Nirpal: Hey, Darshan. Always good to be back with you and going through some of these key topics. So it's been probably a bit too long, so I'm glad we were able to do this. So, yeah, I'm Nirpal. You've probably come across my podcast with Darshan before. I head up Transparency & Disclosure at Certara, and really specialize in the subject matter on our engagements with the law, guidelines, rules around the world, and sort of how we can align our services to best support sponsors. So I'm often talking about this and trying to make sure that we implement some of this guidance back to our sponsors as effectively as we can. Darshan: So, Nirpal, you actually spoke at a conference yesterday and I have to imagine people... We're doing virtual conferences, but I imagine you get a lot of questions. What are the big questions around Brexit that you keep hearing? Nirpal: Yeah, so very timely, actually. It was a very surreal sort of engagement just because I'm so used to having a chat with a larger crowd and really engaging with them. So it was a bit unusual to be trying to do this all virtually sitting at my desk and getting folks to give me some virtual questions. But there was a lot of interests with obviously what's happening with COVID-19 and how that translate to transparency, types of guidelines, and trying to get some of that data out. We're hearing, of course, that agencies feel that they do need to really push for more of this data to come out faster than it has done before. So there's quite a lot of questions about Europe and it was a European audience. What's the EMA trying to do in terms of COVID-19, knowing that a lot of the transparency type of guidelines that they had in place have been on a hold that we all know due to Brexit, that we're going to be talking about. So, yeah, quite a lot of questions about that, and there was quite a bit of interest around MHRA and what might be happening in the UK. So we definitely covered a couple of pointers, maybe not in a whole lot of detail, but yeah, very interesting mix of questions, for sure. Darshan: So let's sort of not pay the huge conference fees, and ask the questions anyways. How is the EMA dealing with Brexit and how has MHRA sort of dealt with the EMA? I know that's sort of the big 700-pound gorilla in the room, and that's a lot to chew on, but love to sort of hear your take on it. Nirpal: Yeah. I mean, it's going to be a completely different type of relationship, right? Where UK has really been at the forefront of EMA, not only physically in terms of where its headquarters were, but obviously, the UK and its reputation and its skillset, were really one of the lead countries when it came to submission approval and evaluation and all those aspects. So it's a very different type of relationship. So MHRA, they've had to really come to terms quickly around how they would manage this process outside of EMA. So there's been a lot of internal things going on. Some things that have actually been posted by the government, just on how progress has been made.