1 00:00:00,080 --> 00:00:07,000 TRANQUIL MUSIC 2 00:00:07,160 --> 00:00:10,160 CHRISTINE GISPEN-DE WIED: Regulatory science is very important. 3 00:00:10,320 --> 00:00:11,680 It's the fuel of the MEB, 4 00:00:11,840 --> 00:00:16,000 and it's also the science behind our decision-making process. 5 00:00:16,160 --> 00:00:20,560 BERT LEUFKENS: We believe that regulatory science is at the heart 6 00:00:20,720 --> 00:00:23,920 of serving and ensuring patient benefit. 7 00:00:24,080 --> 00:00:26,800 The MEB is at the forefront of regulatory science, 8 00:00:26,960 --> 00:00:29,400 at the national level and also at the European level. 9 00:00:29,560 --> 00:00:33,080 LEUFKENS: And that whole concept of bringing 10 00:00:33,240 --> 00:00:36,920 the really important research questions, the best methods, 11 00:00:37,080 --> 00:00:41,880 but also support from the regulatory space, has been a key role 12 00:00:42,040 --> 00:00:45,600 for the, I think, very important position of the MEB at the moment. 13 00:00:45,760 --> 00:00:49,520 THE TRANQUIL MUSIC CONTINUES 14 00:00:49,680 --> 00:00:52,360 When we look at the real challenges of regulatory science, 15 00:00:52,520 --> 00:00:55,640 they are very close to finding the right methods, 16 00:00:55,800 --> 00:00:58,720 also to improve methods to evaluate the benefit-risk 17 00:00:58,880 --> 00:01:02,640 in the most efficient and advanced way. 18 00:01:02,800 --> 00:01:07,120 The MEB is at the spot to bring that further, 19 00:01:07,280 --> 00:01:12,240 also in more excellence, in more alignment with stakeholders, 20 00:01:12,400 --> 00:01:16,640 but at the end of the day also ensuring patient benefit. 21 00:01:16,800 --> 00:01:21,600 And that's essential for the vision of regulatory science. 22 00:01:21,760 --> 00:01:27,440 The MEB should focus on maintaining their strong regulatory science network, 23 00:01:27,600 --> 00:01:33,080 but more importantly, also bring the data that they generated, to the work floor. 24 00:01:33,240 --> 00:01:36,400 LEUFKENS: And in my view, there are three areas I would invest in. 25 00:01:36,560 --> 00:01:42,920 The first is very much on the regulatory system as it is and how it can be improved. 26 00:01:43,080 --> 00:01:46,760 The second is very much on how we evaluate clinical benefit. 27 00:01:46,920 --> 00:01:52,360 And the third is very much on how we can align with other stakeholders, 28 00:01:52,520 --> 00:01:56,520 including payers, patient groups and prescribers. 29 00:01:56,680 --> 00:02:01,280 THE TRANQUIL MUSIC CONTINUES 30 00:02:01,440 --> 00:02:07,520 In the whole context of bringing the Dutch position of regulatory science 31 00:02:07,680 --> 00:02:14,040 to an even higher level, the regulatory science network is a key platform. 32 00:02:14,200 --> 00:02:17,080 GISPEN-DE WIED: Well, the Regulatory Science Network Netherlands 33 00:02:17,240 --> 00:02:21,040 was created two years ago, and it brings together four important parties, 34 00:02:21,200 --> 00:02:26,760 who all work on direct development, being regulatory authorities, 35 00:02:26,920 --> 00:02:30,080 industry, society at large and academia. 36 00:02:30,240 --> 00:02:35,760 It's a unique network, in the context of other networks and institutes in Europe. 37 00:02:35,920 --> 00:02:40,760 And I believe that the MEB is in a key role, also, 38 00:02:40,920 --> 00:02:45,200 to expand that role even further than we have today. 39 00:02:45,360 --> 00:02:47,600 I'm very happy that I was given the opportunity 40 00:02:47,760 --> 00:02:53,360 to keep on working for the Regulatory Science Network Netherlands, 41 00:02:53,520 --> 00:02:55,120 and give a second boost 42 00:02:55,280 --> 00:03:01,160 to the sustainability and further progress of this network. 43 00:03:01,320 --> 00:03:05,240 LEUFKENS: Actually, we were very privileged that we could take the initiative, 44 00:03:05,400 --> 00:03:10,560 and we were also supported by the leadership of the MEB. 45 00:03:10,720 --> 00:03:13,240 And actually, I'm very eager also to continue 46 00:03:13,400 --> 00:03:17,040 in that leadership role for the next couple of years, 47 00:03:17,200 --> 00:03:20,920 and the future will tell, of course, what's next. 48 00:03:21,080 --> 00:03:24,400 But at the moment, we are in a position to contribute. 49 00:03:24,560 --> 00:03:26,600 I think the MEB can maintain its position 50 00:03:26,760 --> 00:03:29,240 by investing in the right people at the right place. 51 00:03:29,400 --> 00:03:32,000 People who see the challenges of regulatory science 52 00:03:32,160 --> 00:03:35,320 and keep connecting to the outside world. 53 00:03:35,480 --> 00:03:39,760 And in that respect, it's great that Bert has a chair in regulatory science 54 00:03:39,920 --> 00:03:41,600 at the University of Utrecht.