🌏 Global regulators from Spain, Japan, and the US are coming together to discuss regulatory convergence efforts for advanced therapies. Join #ASGCT on Sept. 23 in DC or virtually for the Global Regulatory Convergence session at the 2024 Policy Summit to hear from Dr. Sol Ruiz (AEMPS, Spain), Dr. Yasuhiro Kishioka (PMDA, Japan), and Dr. Nicole Verdun (FDA CBER, US). Speakers will offer valuable perspectives on the approval process and current regulations. Registration link in comments below. 👇 Don't miss your chance to engage with these decision-makers! #CGTRegulation #GlobalConvergence #AdvancedTherapies #ASGCTAdvocacy
American Society of Gene & Cell Therapy’s Post
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💥Swissmedic is excited to announce that it will be participating in the International Medical Device Regulators Forum (IMDRF) in Seattle, USA, this September! 🌍 👉The IMDRF, established in 2011, is a voluntary forum that brings together medical device regulators from around the world to advance international harmonization and convergence in this field. As an official observer, Swissmedic is proud to play a role in this vital network and contributing to an efficient and effective regulatory model that responds to emerging challenges while protecting and maximizing public health and safety. 📆From September 16 to 20, 2024, the IMDRF Management Committee will convene in Seattle to discuss key regulatory issues and set the course for the future. We look forward to productive exchanges with our international partners, industry and academia, and continued collaboration on a global scale. 🌐 #Swissmedic #IMDRF2024 #MedicalDevices #RegulatoryAffairs #GlobalHealth #Convergence #Reliance
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💥We are excited to announce that Swissmedic will be participating in the International Medical Device Regulators Forum (IMDRF) in Seattle, USA, this September! 🌍 👉The IMDRF, established in 2011, is a voluntary forum that brings together medical device regulators from around the world to advance international harmonization and convergence in this field. As an official observer, Swissmedic is proud to play a role in this vital network and contributing to an efficient and effective regulatory model that responds to emerging challenges while protecting and maximizing public health and safety. 📆From September 16 to 20, 2024, the IMDRF Management Committee will convene in Seattle to discuss key regulatory issues and set the course for the future. We look forward to productive exchanges with our international partners, industry and academia, and continued collaboration on a global scale. 🌐 #Swissmedic #IMDRF2024 #MedicalDevices #RegulatoryAffairs #GlobalHealth #Convergence #Reliance
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Swissmedic recently updated its clinical trial framework to provide additional protections for participants, increase transparency, and provide a better regulatory structure for researchers. The majority of these amendments will take effect on Nov. 1. More details in the comments ⬇ #regulatory #swissmedic
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Want to learn about the challenges faced in patient recruitment and retention in China? Parexel conducted a qualitative survey involving 20 patients and 24 GCP compliance officers, PIs, and CRCs. Read the findings in this issue of the New Medicines, Novel Insights newsletter. 📚 #clinicalresearch #clinicalresearchchina
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The new ESSD Book out now, enjoy and share. https://lnkd.in/d6gx9t2Y Preface: Drug normalisation is reflexive - Shane Blackman Introduction: Normalised drug using landscapes across Europe - James Morgan, Thomas Friis Søgaard & Alfred Uhl Navigating norms and drug use: Normalisation and neutralisation as converging perspectives - James Morgan & Trevor Bennett Exploring the normalisation of image and performance enhancing drugs (IPEDs) in British gyms and its connectivity with social media - Luke A Turnock & Nick Gibbs ‘That’s how drug scene was back in the days’ – On the temporary de-normalisation of harm reduction measures and public life for people who use drugs heavily during the COVID-19 pandemic - Bernd Werse & Luise Klaus The normalisation of illicit drug use admissions among British politicians: A narrative perspective - Liviu Alexandrescu Revisiting the normalisation thesis in the Polish context over the past 20 years - Greg Los, Maria Plucinska & Artur Malczewski Different-paced normalisation: Cannabis social worlds in non-liberalised contexts - Michal Wanke Normalised drug use heterotopias in the 21st century - Kostas Skliamis Policy normalisation of drug use – opportunity or cultural discomfort? - Alfred Springer https://lnkd.in/dD4sgijx
Drug normalisation and tobacco denormalisation
psychologie-aktuell.com
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I was delighted to participate to this panel on the new European HTA regulation during the HTAi congress in Sevilla. As Medical Device industry, we have 5 important questions that need to be answered through the implementation of this regulation: 1. What is the perimeter of the regulation for medicla devices - i.e. which technology will have to go through the Join Clinical Assessment process ? 2. When in the lifetime of the technology will the JCA be performed ? 3. Will the process be collaborative enough to include HTd in the PICOs (Population, Intervention, Comparator, Outcome) and will it ensure adequate diversity of expertise ? 4. Will the methods be adapted to medical devices specificities ? 5. What will be the impact at country level ? And a big thank you to our 2 moderators, Elena Petelos, Chiara de Waure, and to the panelists Marco Marchetti, Iñaki Gutiérrez-Ibarluzea MSc, PhD, Dimitra Lingri
A very big thank you to all the people who stayed with us until the end of the #HTA Regulation (#HTAR) #EU implementation event at #HTAi2024Seville, many standing or sitting on the floor for 90 minutes! We were aware of the need to raise awareness and start with basic questions, but could not quite imagine how very much this was needed! Particularly thankful to Marco Marchetti of Agenas, HTAi and of the #HTACG (Coordination Group) of the European Commission (EC), Dimitra Lingri of European Healthcare Fraud and Corruption Network (EHFCN), Health Technology Assessment international (HTAi) and of the HTACG of the EC, Frédérique Debroucker of Medtronic, and Iñaki Gutiérrez-Ibarluzea of BIOEF, of Health ClusterNET, and of the Basque Government (Eusko Jaurlaritza - Gobierno Vasco), our panelists, for their energy, patience, open exchange and willingness to engage with our very interactive audience! We are well aware that there was no time to ask and answer as many questions as we would have like and will move forward to collect these after the Health Technology Assessment international (HTAi) AM wraps up. We tried to focus on #medicaldevice specificities, but touch upon broad challenges and opportunities for the European Commission, the HTA Coordination Group (HTACG), developers and Member-States alike. We look forward to tomorrow's discussion on a rather particular aspect of the HTAR, patient engagement too, and also recommend to everyone interested to see the prerecorded panel on #vaccine specificities, with much more on RWE coming up. Thank you, once again, for joining us; do not hesitate to reach to us via our IGs on #RWE & #AI, and #PublicHealth, or directly! #medicines #drugs #publichealth #pharmaceuticallegislation #HEOR
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🎥 On #WorldIPDay, we're excited to unveil our new animated film 🍿 explaining IP and its crucial role in fostering innovation in healthcare 💡 🤔 So, what is IP? How does it work? And why is it important to protect it? Below more info - press play ▶️ #BMS_Employee
On #WorldIPDay, we're launching an animated film explaining IP, especially how it spurs and rewards innovation in medicines. IP creates an environment for ideas to thrive. Sometimes, these ideas eventually yield breakthroughs that can treat, or even cure, serious diseases. By providing a proven pathway to generic competition, IP helps patients to access the healthcare they need at affordable prices. IP comes in different forms - patents, SPCs and RDP. The European Commission, through the revision of the #EUPharmaLegislation, wants to reduce the baseline period of RDP to six years and expand the #Bolar exemption. That would place at risk the global competitiveness of the European IP system. As EU Member States debate the European Commission's proposals, we urge them to work towards a robust and efficient EU IP framework. This is a vital part of future #competitiveness which EU leaders urged last week at a special European Council meeting in Brussels. So, what is IP? How does it work? And why should we protect it? More on the BMS EU policy website https://bit.ly/4aLwBlf. #BMS_Employee #FutureProofingMedicines
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Lead generator & Connector • Business matching • Consultancy for healthcare system & health tech R&D / bioethics / clinical trials / communication • ICH-GCP trained • Patient advocate • Board member for multiple NGOs
2024-01-08 (M) am... Being a night owl in Hong Kong tonight, so I can attend online at the "5th Annual CERSI Innovations in Regulatory Science Summit". A very interesting session is on right now --- "Panel 2: Variation in Regulatory Approaches cross the Globe: How can we work together to make medical products commercially viable & available worldwide". Although the 11:20am session (San Framcisco time) (3:20am my time) actually started ~11:45am (3:45am my time), the sharings & discussions from experts worldwide are insightful. https://lnkd.in/gBj59M3c #CERSI #innovations #medtech #ATMPs #drugs #organtransplants #patients #regulators #providers #payers
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Today's the day Scout goes LIVE with our webinar, "Clinical Research Without Borders: Why Real Global Capability Matters." 🌐 Learn from industry experts about enhancing trial success through effective global operations. It's not too late to join us! https://hubs.ly/Q02v5b5b0
Strategies for Global Clinical Trials: Clinical Research Without Borders
xtalks.com
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We are happy to present a brand-new DIGI-MEd publication focused on the digitisation process in medicines’ clinical trials from a new European regulations’ perspective. IRCCS San Raffaele Hospital's Head of Clinical Research and Development and pharmacologist Professor Carlo Tomino discusses the recent improvements of #EuropeanRegulation on Interventional Drug Clinical Trials (Reg 536/2014) marking a transformative moment for Companies, Healthcare Facilities and Ethics Committees. Professor Tomino analyses the European Union's aim to improve the competitiveness of its clinical research processes by aligning them with global regulatory standards and ensuring high level standards of safety and transparency such as the publication of trials' authorizations, progress and outcomes. Moreover, he emphasises the potential of Italy to maintain its leading role in international research endeavours, since Italian researchers and clinical facilities are among the world's best. Ultimately, those promising perspectives represent an improved citizens' healthcare for the future, keeping in mind the commitment in using a comprehensible language for them during the care progresses. Read the article below to learn more about these important steps towards the digitisation's evolution! . #togethermovefirst #digitalmedicine #digitalhealth #clinicaltrials
Learn more and register today: https://www.asgct.org/advocacy/events-and-opportunities/policy-summit