Regulatory Science Network Netherlands

"The current European Commission’s proposed definition of unmet medical need may not be fit for purpose for future therapies." This was one of the main conclusions of the RSNN Expert Meeting "Addressing the framework of unmet medical need (UMN)", which took place on Tuesday 23 April 2024. During the meeting several predefined questions were discussed by experts regarding (the definition of) UMN in the European Commission's EC proposal for a new Directive and Regulation revising and replacing the existing pharmaceutical legislation. The full meeting report is now available below and on our website: https://lnkd.in/e7kAK3Zs. The report will be also be communicated to the Ministerie van Volksgezondheid, Welzijn en Sport as input towards the discussions currently taking place at the Council on (H)UMN. #unmetmedicalneed #report #regulatoryscience

Uitvoerders gezocht voor een COGEM en CCMO onderzoeksproject naar onbedoelde kiembaanmodificatie bij nieuwe gentherapieën De Commissie Genetische Modificatie (COGEM) laat ter ondersteuning van haar werkzaamheden onderzoek door derden verrichten. Het onderhavige project is een samenwerking met de Centrale Commissie Mensgebonden Onderzoek (CCMO). Het gaat om een literatuuronderzoek, met als doel inzicht te verkrijgen in de kans op onbedoelde kiembaanmodificatie bij nieuwe gentherapieën ter ondersteuning van de risicoanalyse. Geïnteresseerden worden opgeroepen een projectofferte in te dienen. Voor meer informatie:

On Tuesday 11 June, the Regulatory Science Network Netherlands SIG Advanced Therapies together with the Centre for Future Affordable Sustainable Therapies (FAST) organised a workshop & networking event about the potential need for a national platform that could facilitate interaction, knowledge exchange and cooperation in the Dutch ATMP field. In addition to the main topic, Heather Main shared learnings from the Swedish platform ‘ATMP Sweden’ and Arjan Lankester from the AGORA network that aims to facilitate sustainable access to effective gene therapies for treatment of patients with ultra-rare diseases in Europe. The highly multidisciplinary audience clearly expressed a need for a national platform and highlighted that it should mainly focus on continuous mapping of stakeholders and initiatives to facilitate interaction and collaboration, as well as function as a single point of contact, both from a national and international perspective. The presentations and a selection of photos from the meeting are now available on the RSNN website: https://lnkd.in/eE_5WY-J A meeting report will be published and shared in September 2024. #workshop #ATMPs #genetherapies

“Trust is the key to success in implementing Machine Learning systems in Regulatory environments” and “Cross-stakeholder collaboration is an important enabler for AI in medicine development”. These were just two of the many take-home messages from last Tuesday’s RSNN Annual workshop. We are looking back at a successful Regulatory Science Network Netherlands (RSNN) Annual workshop last Tuesday on the topic of Artificial Intelligence in Regulatory Innovation. Featuring various inspiring speakers, the workshop brought together experts from diverse backgrounds who shared their expertise and passion on the stage. Their presentations and the subsequent panel discussion provided many new insights into the topic of AI in Regulatory Innovation, including expected benefits and challenges. The audience actively participated, stimulating dynamic interactions throughout the workshop. Networking opportunities were also a significant aspect of the event, which enabled participants to connect with both new and existing stakeholder representatives during the break and networking dinner that concluded the day. We want to extend a big thank you those who joined us, your presence and active engagement made this workshop such a success! The presentation files and a selection of photographs from the workshop are now available on the RSNN website:https://lnkd.in/eXDqiy5K. The full scientific report of the workshop is being prepared and will be published soon. #thankyou #workshop #innovation #artificialintelligence

This afternoon we are discussing Artificial Intelligence in Regulatory innovation during the Regulatory Science Network Netherlands (RSNN) Annual Workshop. AI is emerging as a transformative tool in regulatory science, revolutionizing traditional approaches to ensuring the safety, efficacy, and quality of products and services. We will use today’s workshop to share knowledge and experiences of the use of AI in regulatory innovation from various perspectives. After presentations from speakers on the subject, we will discuss different viewpoints in a panel session which will also enable active participation from the audience. We are looking forward to exciting new insights and lively discussions! #workshop #regulatoryinnovation #artificialintelligence

Ready, set, go! We are off for a day filled with Regulatory Science at Villa Jongerius. This morning the Regulatory Science Network Netherlands (RSNN) Special Interest group ATMPs together with Future Affordable Sustainable Therapies (FAST) is hosting a workshop and networking event. The event is aimed at exploring the potential of ATMP-NL, a central entity to stimulate coordination, knowledge exchange and cooperation in the Dutch ATMP field. In the afternoon the RSNN will host its Annual Workshop on the topic of Artificial Intelligence in Regulatory Innovation. During the workshop knowledge and experiences of the use of AI in regulatory innovation from various perspectives will be presented and discussed. We are looking forward to welcoming many participants for both sessions and expecting lively discussions and great networking opportunities throughout the day! #atmps #regulatoryinnovation #workshop

If you are at the College ter Beoordeling van Geneesmiddelen collegedag today, make sure to drop by Sophie Huiskes-Berends at the RSNN booth to find out more about our network's activities!

In the Netherlands, drug regulatory science is a vibrant national and internationally oriented community. How did regulatory science evolve in the Netherlands? Which factors have contributed to this successful collaboration between relevant stakeholders in regulatory science? Medicines Evaluation Board (MEB)-colleagues Marjon Pasmooij and Peter Mol with both also positions at Utrecht University and University Medical Center Groningen, respectively, together with former chair of the MEB Bert Leufkens and Sjaak Bot, wrote a paper describing how a research project (TI Pharma Escher), facilitated by the MEB made the big jump to a national collaboration (Regulatory Science Network Netherlands) to streamline drug development and regulation. Three pivotal episodes are distinguished: (i) TI Pharma Escher-project, (ii) MEB as catalyst of the big jump, and (iii) Regulatory Science Network Netherlands and multistakeholder engagement. The paper presents various examples that show how drug regulatory science can expedite novel developments making a public health impact! Read the paper 'The evolution of drug regulatory sciences in the Netherlands: More than a country report' in American Society for Clinical Pharmacology & Therapeutics here: https://lnkd.in/eAugzV36 Future Affordable Sustainable Therapies, Central Committee on Research Involving Human Subjects (CCMO), Utrecht Centre for Pharmaceutical Policy and Regulation, UMCG research #regulatoryscience

Only a few spots left for the RSNN Annual Workshop "Artificial Intelligence in Regulatory Innovation" on 11 June in Utrecht! All speakers have now been confirmed and the full program is available on the event site: https://lnkd.in/gZScJM69 During the workshop, knowledge and experiences of the use of AI in regulatory innovation will be shared from the perspective of regulators, patients, industries, academia, and other stakeholders. The workshop will also feature a panel discussion, interaction with the audience, and ample networking opportunities. Register now to secure your spot: https://lnkd.in/gWrTE4VQ #workshop #regulatory #artificialintelligence

Only a few spots left for the RSNN Annual Workshop "Artificial Intelligence in Regulatory Innovation" on 11 June in Utrecht! All speakers have now been confirmed and the full program is available on the event site: https://lnkd.in/gZScJM69 During the workshop, knowledge and experiences of the use of AI in regulatory innovation will be shared from the perspective of regulators, patients, industries, academia, and other stakeholders. The workshop will also feature a panel discussion, interaction with the audience, and ample networking opportunities. Register now to secure your spot: https://lnkd.in/gWrTE4VQ #workshop #regulatory #artificialintelligence