ASPHALION

📌 People Talks | Meet our exceptional team! 🚀 At ASPHALION, our #success is driven by the #dedicated and #passionate individuals who make up our incredible #Team. Today, we wanted to highlight and share the #ASPHALION journey of Itxaso Beltrán de Guevara, Medical Device Officer, on our “People Talks”.  ↪️ “I feel fortunate to work with a diverse range of #devices, #companies, #professionals, #regulatorybodies, and #health authorities. This exposure provides me with a comprehensive understanding of the market and its evolving needs..” 🔝 What Itxaso likes most about #ASPHALION:   ✅ Close relationship among colleagues ✅ Exchange of ideas ✅ Collaborative work environment ✅ Flexibility ✅ Personal and professional life balance 🔗 Read the full interview here: https://bit.ly/4eNMbyK ▶️ Stay tuned for more insights about the talented professionals who make Asphalion what it is today! 👀 Fancy joining us? Have a look here at our careers’ opportunities: https://lnkd.in/d-fVH_KV #PeopleTalks #RegulatoryAffairs #WeAreAsphalion #WeCare #KnowledgeFromExperience #Team #AsphaTeam #MeetTheExpert #TeamAsphalion #JoinUs

📌 Poster | AI in Pharmacovigilance: transforming literature searches with advanced technologies   ▶ Literature #screening is an essential process in the field of #Pharmacovigilance (PV), as it facilitates the identification of relevant information regarding the #safety and #efficacy of #medicinalproducts. Artificial intelligence (#AI) integrates advanced #technology and machine learning techniques in PV #literaturesearches, thereby accelerating the #datacollection process and allowing the analysis and interpretation of large volumes of information with unprecedented accuracy.   ▶ Have look at the poster that ASPHALION experts Sonia López and Laura Eder prepared for the #WorldDrugSafetyCongress2024 about “#AI in #PV: transforming literature searches with advanced #technologies”.    📧 For further information, contact us at: info@asphalion.com   #ArtificialIntelligence #DigitalRevolution #RA #RegulatoryAffairs #PV #Farmacovigilancia #WorldDrugSafetyCongress #WDSC24 #MeetTheExperts #WeAreAsphalion #WeCare #KnowledgeFromExperience https://bit.ly/4eKICcV

📌 FREE WEBINAR | How to best interact with a Notified Body for a successful MDR Application 📅 November 27  🕒3:00 pm  💻 Online     🔝 Join BSI expert Pilar Maldonado and ASPHALION expert Koldo García de Acilu as they  thoroughly explore the #qualification and #classification processes for #medicaldevices under the #MDR (Regulation EU 2017/745), the available #conformityroutes, guidance on achieving compliance with #EuropeanRegulations, among many other.  The objective is to provide you with a comprehensive overview of the #RegulatoryPathway, ensuring participants understand the full process for #medicaldeviceapproval. 🗝️ Topics: ·       ASPHALION Regulatory Affairs consultancy - MedTech services ·       Qualification and classification of #MDs under MDR ·       Conformity routes under MDR ·       BSI GROUP & BSI Regulatory Services ·       General #NB update ·       BSI Application portal & guidance ·       MDR process & timelines 🔗 Register here: https://bit.ly/3NqVY1W #Webinar #FreeWebinar #MedTech #NotifiedBody #OrganismoNotificado #NotifiedBodies #MD #MedicalDevice #EURequirements #Europe #MDR #MeetTheExpert #RA #RegulatoryAffairs #WeAreAsphalion #WeCare #KnowledgeFromExperience   https://bit.ly/3YozzbM

🙌¡Muchas gracias por la bienvenida! Estamos encantados de unirnos al #clúster MAD e-Health junto a otras empresas #innovadoras en el sector. ↪ En ASPHALION, seguimos comprometidos en ofrecer soluciones de vanguardia. Nuestro equipo de expertos en #MedTech está siempre a punto para ayudarte a cumplir con los #desafíos del mercado y con todos los #requisitosregulatorios y de #calidad de tus #DispositivosMédicos, asegurando el éxito en cada etapa. 🚀 ¡Estamos listos para afrontar los nuevos retos juntos! 📧 Contáctanos para cualquier información: info@asphalion.com 📅 Agenda una reunión gratuita de 30 minutos con nuestros expertos: https://bit.ly/3NwVsNR #RegulatoryAffairs #MedicalDevices #MD #DispositivosMedicos #MedicalDevice #MDR #IVDR #WeAreAsphalion #WeCare #RA #RegulatoryAffairs #KnowledgeFromExperience

📌  WEBINAR | Productos Sanitarios Implantables a Medida (Clase III) 🗓️ Martes, 29 de octubre de 2024 ⏰ 11:00- 11:45 (CET) ¡No te pierdas este #webinar conjunto de SGS y ASPHALION! 🎙️ Ponentes #SGS España: Maria Teresa Gomez Manzano y Ana María Silva 🎙️ Ponente #Asphalion: Talyta Carteano ¿Por qué es importante? 💡La #MDR (Regulación EU 2017/745) impone nuevos requisitos para los #productosimplantables de clase III #custommade, que ahora requieren #auditorías y evaluación por #OrganismosNotificados. Estos cambios afectan a #fabricantes y #consultores, que deberán adaptarse a las normativas antes de 2026. ¿Por qué asistir? 🔍Este webinar es una oportunidad clave para conocer los #cambios más relevantes en la MDR y cómo cumplir con las nuevas #exigenciasregulatorias. Obtendrás una visión clara de los pasos necesarios para garantizar la #conformidad y anticiparte a posibles desafíos. 🔗 Más información e inscripción: https://bit.ly/4exEFrX   https://bit.ly/4eFjXpY #Webinar #FreeWebinar #MedTech #EU #NotifiedBodies #NotifiedBody #OrganismoNotificado #MedicalDevices #MD #EURequirements #Europe #MeetTheExpert #RA #RegulatoryAffairs #WeAreAsphalion #WeCare #KnowledgeFromExperience  

📌 WEBINAR | Biological Impurities: scientific and regulatory aspects Join us for a Joint Webinar by Kymos Group and ASPHALION experts! 📢 We are excited to announce a special webinar hosted by experts from #Kymos and #Asphalion on October 24th, focusing on the critical topic of Biological Impurities: Scientific and Regulatory Aspects. 🎤 Asphalion featured Speaker: Mario López de la Cruz, Scientific & Regulatory Affairs Senior Consultant 🔑 Topics: 🔹 Introduction to biological drugs: definition and particulars 🔹 ICH, EMA, and FDA guidelines 🔹 General concepts 🔹 Requirements for specific types of products 🔹 Quality attributes and analytical methods 🔹 Case studies 🔹 Key takeaways 🔹 Q&A session 🔝 This webinar will provide invaluable #insights into the #regulatory landscape and #scientific considerations for #biologicalimpurities. Don’t miss this opportunity to learn from industry leaders! 🔗 Further information and registration: https://bit.ly/4878Of3 #Webinar #Kymos #Asphalion #BiologicalImpurities #RegulatoryAffairs #Pharma #Biotech #AnalyticalMethods #WeAreAsphalion #WeCare #KnowledgeFromExperience https://bit.ly/3U9l4Gk

📌 Curso | Expedientes electrónicos de registros EU: Actualización portal PLM eSubmission 📆 3 de diciembre, 2024 💻 Online   ¿Trabajas en la #industriafarmacéutica y buscas estar al día en las novedades #regulatorias y #telemáticas? ¡Este curso es para ti! 👩🏫 Apúntate a esta formación virtual organizada por iKN Spain donde los expertos ponentes, Ana Viñas de la Agencia Española de Medicamentos y Productos Sanitarios y Vicente Tur de ASPHALION analizarán las últimas novedades en #eCTD, portales de envío, #SPOR, #PLM y la implementación de #ISOIDMP, entre otros. ¿Qué aprenderás? 🔹 Transformación digital con #RIMS 🔹 Novedades en el formato #eCTD y Módulo 1 🔹 Uso de portales europeos como #CESP e #IRIS 🔹 Integración de SPOR y gestión de #PLM 🔹 Implementación del estándar #ISO IDMP 🎉 Oferta especial: Inscríbete ahora y recibe un 20% de descuento exclusivo utilizando el código 20TUR. ℹ Más información e inscripciones: https://lnkd.in/djSqc6rU #IndustriaFarmacéutica #RegulatoryAffairs #eCTD #ISOIDMP #SPOR #PLM #Formación #Descuento #submissions #eSubmissions #DataManagement #Pharmaceuticals #Pharma #DADI #WeAreAsphalion #WeCare #KnowledgeFromExperience #RegulatoryAffairs #MeetTheExperts https://bit.ly/3YnS4gs

📌 AWARENESS | WORLD ARTHRITIS DAY 2024 🌍 Today is #WorldArthritisDay2024—a reminder that over 500 million people in Europe are affected by Osteoarthritis (#OA). Current treatments provide only moderate relief and often come with long-term side effects, leaving many in #pain. ↪ At ASPHALION, we’re proud to be part of the EU-funded siNPAIN, a groundbreaking international project aimed at improving the quality of life for #OApatients. Together with our partners, we are working on an innovative #nanotherapeutics pipeline using #siRNA to target different stages of #kneeOA. ↪ Our vision? To deliver a new generation of #OAtherapeutics that can #alleviatepain, reduce the burden on #healthcare systems, and offer hope to millions suffering from this debilitating #disease. Together, we can bring relief to OA patients worldwide. 📧 Contact us should you need further information: info@asphalion.com #WorldArthritisDay #siNPAIN #Osteoarthritis #InnovativeTherapies #HealthcareInnovation #Asphalion #EUResearch #KneeOA #Nanotechnology #RA #RegulatoryAffairs #WeAreAsphalion #WeCare #KnowledgeFromExperience https://bit.ly/3Y0LlHS

📌 EVENT | World Drug Safety Congress 2024 wrap up 👏🏽 Fantastic #WDSC24 event in Amsterdam!!! 🔝 Thanks for visiting our booth. It was a pleasure to connect with so many professionals in #drugsafety and #pharmacovigilance! 📧 We’d love to discuss how we can #collaborate and #support your #projects. Feel free to reach out at: info@asphalion.com. 🌟 We’re already looking forward to seeing you again at next year's event in #Amsterdam! Stay tuned for more updates. #WDSC2024 #Safety #DrugSafety #Vigilance #PharmaIndustry #Pharmacovigilance #PV #RA #RegulatoryAffairs #WeAreAsphalion #WeCare #KnowledgeFromExperience Sonia, Alicia, David, Helena, Joao

📌 EVENT | CPHI congress wrap up 🎉 What an incredible time at CPHI Milan! 🙌🏽 A huge thank you to everyone who stopped by ASPHALION's booth. It was fantastic to meet so many of you and discuss how we can support your #projects in the #lifesciences and #pharmaceutical industries. Your interest and engagement made it a memorable #experience! 📧 Haven’t met you yet? Contact us! We’d love to connect and explore how we can collaborate. Reach out anytime at: info@asphalion.com. 🌟 We’re already looking forward to meeting you again in #Frankfurt next year! Let’s keep the momentum going! #CPHI #CPHI24 #RA #Pharma #CPHIFrankfurt2025 #LifeSciences #RegulatoryAffairs #DrugSafety #MedTech #Pharma #PharmaWorld #Pharmaceuticals #PharmaExperts #BiotechExperts #MedTechExperts #WeAreAsphalion #WeCare #KnowledgeFromExperience Lidia, Michael, Oriol, Elena, Inés, Mariona, André, Vanessa, Laura