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A regulatory conference that can’t be missed
The conference will explore the UK’s global capability for clinical trials, how we bring innovative medicines to market, evidence generation in support of regulatory decision-making and looking to the future, what will the role of the regulator be as part of the global innovation ecosystem?
Our senior expert speakers have been drawn from the life science industry, UK and EU regulatory authorities, the Department of Health and Social Care, NHS England, the National Institute for Health and Care Excellence (NICE), academia, research charities, and patient organisations.
To learn more about the conference, we sat down with Emma Du Four, Chair of the BIA Regulatory Affairs Advisory Committee and Head of International Regulatory Policy and Intelligence at Abbvie.
Emma explained to us what she is looking forward to at the conference and why it is important for people from across the life sciences sector to attend.
What is the aim of the BIA regulatory conference?
The conference has a great history. Over the last few years it’s really been a venue for driving conversations, and I think that will be the same again this year. It is a great opportunity to bring multiple stakeholders together and really think about regulatory science and the future.
What is the conference going to be discussing?
The approach we have tried to take with organising the conference this year is to really look at the whole life cycle of a medicine and think about how, by continuing to explore the wonderful science base in the UK as a venue for global clinical trials, that really does pull through to the complete life cycle of product development. Conducting research in a great place like the UK also supports opportunities for bringing those products into the regulatory licencing process efficiently. But we really do need to think more broadly about patient access these days, it isn’t just with the regulators, it’s also the HTA bodies, it is how we show value using multiple sources of evidence, so all of these will be covered on the day.
Then we will wrap up with a look to the future, which is always a nice way to end a conference.
Why is it important that those working in the life sciences eco system attend the conference?
I think a common aim that everybody shares in the sector is bringing innovative products to patients. And really the theme of the conference – and it’s an ongoing theme from previous years – is about how we do that in an evolving landscape. The world is not standing still, we’ve got lots of change. This is a great opportunity to discuss and hear the latest thinking across the life cycle of medicines.
Who will be speaking at the conference?
The important message is that we have such a breadth of speakers. We have senior officials from the MHRA, NICE, NHS England, all the people you would expect to be represented and speak at the conference. But we also have others who will bring another dimension of the UK science base, we have researchers, patient group organisations and other regulators as well. So it really is the breadth of speakers - lots to look forward too.
Brexit continues to dominate the headlines, will Brexit be discussed at the conference?
Brexit isn’t something you can ignore and it’s really in the background for any topic. We intentionally didn’t want to just talk about Brexit. It’s important to think of the broader ecosystem and what’s happening. Yes, there will be a flavour of Brexit here and there but if you look at the title ‘Innovation and regulatory science in an evolving environment’, I think certainly Brexit is part of that environment.
What are some of the key issues that will be affecting regulation moving forward?
Some of the themes are at the core of everything we are doing, and in particular the topic of 'evidence.' We are now very aware of big data, Artificial Intelligence and other sources of data that are becoming increasingly important. So you will see that through the presentations over the course of the day.
Also, how the regulatory system is global in nature; activities in one country or one region resonate across the world. So really just trying to take a step back and say medicine development is a global initiative and where can the UK play a role in that.
When you have been to the conference in the past, what’s the atmosphere been like?
I remember last year at the end, there was a real buzz in the room, it felt like that this was a real rare opportunity to bring together such a range of stakeholders and really have a free flowing conversation.
Yes, there are presentations and panel sessions as you would expect but we always build in a lot of time for questions and answers. In the luncheon and refreshments breaks it’s all about the networking. Really having the chance to think about what’s important at the moment and how we can make progress.
What are you most looking forward to?
I’m looking forward to meeting a lot of old friends and making new ones as well. This is a fantastic opportunity, to come and ask the questions you’ve got burning to our wonderful stakeholders - so it should be a great conference.
To sign up for the conference or to find out more information please follow this link