RAPS Nordic Local Networking Group’s Post

Important Update RE the 7th European Conference on SVA

For all of you Colleagues! The DIA Global Forum/June 2024 Issue has many interesting articles including those linking clinical research with regulatory matters such as: 1) The Role of RWD and RWE in Shaping Global Regulatory Practices by Jeffrey Brown, TriNetX, LLC. 2) IDMP and Cross-Border Healthcare: Eliminating Language Barriers (Part 4) by Panagiotis Telonis, EMA; Ta-Jen Chen & Ron Fitzmartin, US FDA; and Julia Nyman & Malin Fladvad, WHO-UMC. 3) The Global IDMP Working Group Focus on a Framework for Global Implementation (Part 5) by Isabel Chicharo & Panagiotis Telonis, EMA; Ta-Jen Chen & Ron Fitzmartin, US FDA; and Malin Fladvad & Olof Lagerlund, WHO-UMC. Thank you to all colleagues and authors listed above as well as other authors who contributed to this DIA Global Forum June 2024 issue. Your contributions and thought leadership makes a difference in our understanding of the topics covered. Interested in writing an article that links clinical research with regulatory matters? Contact me here. It would be a great honor for me to work with you in my capacity of Regulatory Science Editor. https://lnkd.in/gg8gfcMX #FDA #clinicalresearch #clinicaltrials #regulatoryaffairs

🌟 Stay informed about the activities of the SCTO! 🌟 Dive into the SCTO #newsletter to discover the latest national and international clinical research news, as well as updates from the Clinical Trial Unit (CTU) Network and SCTO Platforms. In our newsletter, for example, you'll discover: 🔹 New tools and resources developed by the SCTO Platforms. 🔹 Upcoming SCTO events, published papers with contributions from the SCTO and updates on patient and public involvement (PPI). 🔹 Exciting news, courses and events from our stakeholders. 🔹 Insight into the latest challenges, changes and innovations in clinical research. 👉 Subscribe to our newsletter: https://lnkd.in/eRag5Kk6

We are excited to share with you our ambitions for the next 4 years. Building on the achievements of the past strategic plan, and the decade since ECRIN has achieved its ERIC status, the new strategic plan is marks a consolidation phase for ECRIN. To meet our objectives we have built the strategic plan around five overarching goals to drive ECRIN’s activity for 2024-2027: 1) Ensure scientific excellence and public health relevance 2) Cultivate a thriving and empowered ECRIN community 3) Forging the path for future ECRIN activities 4) Consolidate and promote our visibility and awareness 5) Sustain engagement with the research infrastructure ecosystem Delve into our strategic plan today: https://lnkd.in/eAmEEcT3 CZECRIN, Infrastructure F-CRIN, GreCRIN, HNHRA, HRB National Clinical Trials Office (NCTO), ItaCRIN, KKSN, NorCRIN, PCTN, PtCRIN Portuguese Clinical Research Infrastructure Network, Spanish Clinical Research Network (SCReN), SLOVACRIN, Swiss Clinical Trial Organisation, ERIC Forum

"Current Ethical and Legal Issues in Medical AI" 🤖 Event on 17 June at University of Copenhagen, Faculty of Law (Njalsgade 76, Moot Court Room) ⚖ Keynote speakers: I. Glenn Cohen (Harvard Law School, The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School), Emilia Niemiec (CeBIL), Nicholson Price (University of Michigan Law School), Hannah Louise Smith (CeBIL) and Timo Minssen (CeBIL) "We discuss why explainable AI often cannot achieve what it promises. There is, however, an alternative — interpretable AI/ML — which we will distinguish from explainable AI/ML. Interpretable AI/ML can be useful where it is appropriate, but represents real trade-offs as to algorithmic performance and in some instances (in medicine and elsewhere) adopting an interpretable AI/ML may mean adopting a less accurate AI/ML." 

Join us at the Bioprocessing Summit in Barcelona, Spain, from March 19th to 21st and meet our COO, Michael Sokolov, and one of our Process Modeling Engineers, Guilherme Ramos. Our Chief Operating Officer will be presenting a talk on "The Role of Digitalization in Continuous Processing of Therapeutic Proteins" and "Mastering the Digitalization Challenge for Biopharma Processes – From mAbs to Emerging Modalities". Do not miss this opportunity to connect with them and discover how you can accelerate bioprocess development with confidence! #BioprocessingSummitEurope #CHIBioprocessingSummit #ProcessDevelopment  #TherapeuticProteins #biopharma #bioprocessing #artificialintelligence #digitalplatform #digitaltransformation #digitalization #pharmaindustry #pharmaceuticalindustry #lifescience #lifesciences

Exciting new Master programme

Save the dates

VCTC goes to SCRS! ☀️ We had a fantastic time in Cascais, Portugal at this year's SCRS European Site Solutions Summit 2023. The discussions were all very interesting, and here are some of our key takeaways! ◾ Better communication is still needed between sponsors, CROs and sites. Everyone seems very keen to embrace change, but this theme is recurring at every conference we’ve visited this year and last. We’d be interested to understand how, or what will influence change. Or whether its all just conference chat to fill an agenda. ◾ Sponsors and CRO’s often put technology and processes in place with the aim to support sites, but often it just requires sites to duplicate efforts. ◾ Lots of sponsors are searching for sites, many actively sharing their pipeline and supporting sites to find the right trial for them, which is fantastic. ◾ Quality is not just a set of processes it’s the training of people and how it is completed effectively. Training inefficiency was a big focus of this conference. ◾ Traditional sites are beginning to accept DCT models, but only on those trials where it clearly makes sense. Otherwise, traditional sites will continue to deliver traditional trials. ◾ Diversity in clinical research has long been a challenge and is now one of the key areas for many organisations involved in trials. ◾ Sites should be heavily involved in study considerations during project start-up, to ensure that anything put in place actually helps the site and patients, rather than hinders them. We look forward to seeing how these changes will be implemented in the year ahead. If you’d like to hear more about how VCTC is contributing to these changes, please get in touch! #empoweringpatients #patientcentricity #decentralizedtrials #virtualtrials #clinicaltrialsite #clinicalresearch

Our expert colleague, Peter Watts, will be speaking at the Smithers E&L Europe Masterclass, on November 4th at 3pm, in Vienna. His topic is "Selection of PoDs for TI derivation and toxicological risk assessment of medical device E/Ls" and will include: ➡ Health risk assessment of E/Ls typically involves comparing a tolerable exposure with an estimated exposure figure ➡ The tolerable exposure (Tolerable Intake; TI) is dependent upon the choice of point of departure (PoD) ➡ Ultimately, so is the margin of safety (MoS) for each E/L and conclusion on device safety The presentation will discuss some of the factors affecting the choice of PoD, including: ➡ Choice of key study based on duration ➡ Effect of study route on choice of key study ➡ When study quality can impact on study choice ➡ Way forward when study NOAELs vary ➡ Should you choose a NOAEL or LOAEL as PoD? ➡ Read-across v TTC – science v conservatism? Pete is looking forward to speaking, along with our friends Reinhard Stidl (at Safetree Consulting e.U. ), Erica Dahl, PhD DABT (at Trinity Consultants - SafeBridge) and Soroosh Bagheriasl , PhD (at MediPhorum)...have you got your ticket yet? Let us know if you'll be there! ⭐ https://lnkd.in/e5Y-7Q6v