Swissmedic

📅 Yesterday, participants in the Swissmedic Regulatory Training engaged in a hands-on day at our lab facilities in Berne, gaining valuable insights into quality management practices. Experts from various countries joined our team to explore effective methods for ensuring the safety, efficacy, and quality of medical products and health technologies. 🧪🔍 This collaborative exchange of knowledge helps strengthen regulatory systems globally, and we are inspired by the dedication of these professionals to enhance public health. 🤝Together, we can contribute to the advancement of health systems around the world.🌐   #SwissmedicTraining #GlobalHealth #RegulatoryTrainings #RegulatorySystemsStrengthening 

This week, Swissmedic experts Ulla Grauschopf and Helen Thomas participated in the CASSS CMC Strategy Forum in Rotterdam, sharing their insights on key regulatory topics with industry representatives and colleagues from partner authorities. Key discussions revolved around AI/ML in pharmaceutical manufacturing, post-approval change management, and reliance. We were particularly pleased to hear that industry representatives acknowledge our proactive involvement in the ICMRA 🤝. This recognition motivates us to continue collaborating with partner authorities on innovative solutions, with the aim of enhancing access to high-quality, safe, and effective medicines worldwide 🌍. A big thank you to everyone involved for the valuable and stimulating discussions! 🙏 #RegulatoryAffairs #Pharma #CMC #Swissmedic #ICMRA #PACMP

📢 Today, we are excited to kick off another edition of our Regulatory Training at Swissmedic! From October 21-25, 2024, we are welcoming delegations from National Regulatory Authorities (NRAs) across the globe, including Angola, Colombia, Cuba, India, South Africa, and Uzbekistan. 🌍 Since 2018, in collaboration with the World Health Organization (WHO), this training is part of our long-standing commitment to strengthening regulatory systems worldwide. Together, we aim to enhance regulatory capacities through peer learning and hands-on experience, aligning with WHO standards and global best practices in areas like Quality Management Systems, Authorisations, and Surveillance. 🏆 Since the program’s inception, over 350 experts from 70 countries have benefited from this exchange, contributing to more effective regulatory practices worldwide. 💡 We look forward to a week of collaborative learning and valuable exchange, working together to strengthen regulatory systems across the globe! World Health Organization, Hiiti Sillo, Alireza Khadem Broojerdi, Sunday Kisoma, Agnes Sitta Kijo, Razieh Ostad Ali Dehaghi 🔗 Learn more about the impact of these trainings: https://lnkd.in/dJShFcvb #RegulatoryTraining #CapacityBuilding #GlobalHealth #Swissmedic #WHO #RegulatoryScience #WHOListedAuthority

💡The 26th IMDRF meeting in Seattle, Washington was once again a great opportunity and privilege for Swissmedic to attend, share ideas and discuss ways forward with regulatory colleagues from around the world. Swissmedic provided an update on progress since March 2024, and it was great to see Swiss Medtech representing the Swiss industry. The reach of the IMDRF has increased significantly since the introduction of Affiliate Membership. The attending countries represented more than 60% of the world's population. 🌍 🤝 We remain fully committed to supporting IMDRF’s mission of advancing a robust and effective regulatory framework that addresses emerging challenges while protecting public health. The collaboration and increasingly strong bonds between regulatory agencies is crucial to ensuring life-saving medical devices reach those in need, and to better protect them from deficient devices. Furthermore, the IMDRF meeting highlighted how regulatory systems can collaborate to drive innovation, with significant progress in medical device regulation and harmonization, particularly in low- and middle-income countries. 🚀 🙏 A special thank you to the US FDA for hosting such a successful event. We look forward to continuing our partnerships and the next meeting in Tokyo! #IMDRF #IMDRF2024 #HealthCare #MedicalDevices #SwissmedicInternational #Collaboration

ICMRA “RARE” Symposium and Workshop   📢As the Swiss Agency for Therapeutic Products, we have been actively involved in shaping international networks and global standards for many years. This includes forward-looking regulatory initiatives and contributions to innovations and new technologies in the pharmaceutical industry.   In this spirit, we initiated – under the umbrella of the ICMRA (International Coalition of Medicines Regulatory Authorities) – a multi-stakeholder engagement focusing on rare diseases, which took place this week in Lugano.   📅The event took place against the backdrop of an outdated classical orphan drug designation, which is now about 40 years old. Today the term “orphan drug” seems to be used more often in the sense of “orphan-like drug” for product development in very small populations or subgroups. In other words: rare diseases have become somehow common. Additionally, there are about 8,000 known truly rare diseases.   🔍Therefore, I firmly believe that the definition and concept of the orphan drug designation should be critically reflected and revised in different dimensions: definition, criteria and regulatory incentives, ideally based on an international consensus – for the benefit of patients with truly rare diseases as well as for product development in very small populations or subgroups.   💡Against this background, the aim of the event was to look closely at the challenges and opportunities encountered with (ultra-)rare diseases in regulatory science as part of the vision for “an evidence-based framework and authorisation of the future”, to better involve patients and caregivers, and to examine the opportunities of digital health technologies in this field.   🙏I hope these two days have contributed to these goals, will stimulate further discussion and some progress in the field of truly rare as well as orphan-like diseases and – last but not least – will help to save more lives of affected patients.   #accessconsortium #projectorbis #internationalcouncilforharmonisation #IMDRF #ICMRA Official LinkedIn Account of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) 

Great experience speaking on Day 2 of the IMDRF 26th Conference about the latest regulatory updates from Switzerland🇨🇭 impacting the medical device industry. It was inspiring to exchange ideas with such a knowledgeable and forward-thinking group of professionals. Exciting times ahead for innovation and collaboration in global regulatory frameworks! #IMDRF2024 #RegulatoryUpdates #MedicalDevices #Swissmedic

Ich hatte heute die Gelegenheit, an der jährlichen Schwerpunktaktion von Swissmedic, Swiss Sport Integrity und dem Bundesamt für Zoll und Grenzsicherheit BAZG im Postzentrum Zürich-Mülligen teilzunehmen. 📦 Vor Ort werden verdächtige Pakete untersucht 🔦 und Sendungen von Medikamenten, welche den Monatsbedarf übersteigen, konfisziert. ⚠ Die Gefahr, die von Arzneimitteln aus unbekannten Bezugsquellen im Internet ausgeht, ist gross, wie Laborbefunde der Swissmedic immer wieder zeigen. 🙏 Ein grosses Dankeschön an Ruth Mosimann und Nicolas Fotinos für die spannenden Einblicke in die Thematik. Es war aufregend, dabei sein zu können.   Mehr Informationen: Illegale Arzneimittel aus dem Internet, https://lnkd.in/esZx8TAK

Thank you, Emer Cooke, for the kind words. We greatly appreciate the valuable exchange of knowledge and expertise at the #RARE Symposium. Collaborating with international experts is key to developing innovative solutions that address the regulatory and technological challenges posed by rare and ultra-rare diseases🌍🔬 We look forward to pursuing these fruitful discussions and seeing the outcomes of this important initiative.

💥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