📌 FREE WEBINAR | Signal management process in veterinary #PV: Key Points 📅 December 12 🕒3:00 pm 💻 Online ▶ Ready to gather valuable #insights from industry #professionals on effective methods for identifying, evaluating, and communicating signals? 🔝 Join ASPHALION expert Laura Eder Azanza, PhD. in this first session of our transformative two-part #webinar series on #signalmanagement in #veterinarypharmacovigilance, designed to align with new #regulations. 🔗 Register here: https://bit.ly/4fev0pY #Webinar #FreeWebinar #SignalManagement #PV #Pharmacovigilance #Safety #Farmacovigilancia #FV #MeetTheExpert #RA #RegulatoryAffairs #WeAreAsphalion #WeCare #KnowledgeFromExperience https://bit.ly/3UxdWno
ASPHALION
Fabricación de productos farmacéuticos
Barcelona, Catalonia 40.339 seguidores
Scientific and Regulatory Affairs consultancy with offices in Barcelona, Madrid, Pamplona, Munich and London.
Sobre nosotros
Asphalion is an international Scientific, Regulatory and Safety Consulting In Life Sciences, with offices in Barcelona, Madrid, Pamplona, Munich and London. We collaborate with Pharma and Biotech companies facilitating Drug Development and Regulatory Affairs projects for Drugs, Biologics, Biosimilars, ATMPs and Medical Devices. Our involvement ranges from early development, throughout registration, until marketing and post-commercialization phases. Since the company foundation in 2000, we have consistently grown and now have a team of over 100 employees with backgrounds in all areas of life sciences. Our consultants are experts in their fields and are in direct contact with European agencies for the im-plementation of new regulatory standards. We provide global services and work for hundreds of clients from around the world. Through collaborations with partners in all other continents, we can accelerate your worldwide scientific and regulatory activities by using local expertise. Medicines for Europe (MFE) members. Awarded sustainable company by EcoVadis.
- Sitio web
-
http://www.asphalion.com
Enlace externo para ASPHALION
- Sector
- Fabricación de productos farmacéuticos
- Tamaño de la empresa
- De 51 a 200 empleados
- Sede
- Barcelona, Catalonia
- Tipo
- De financiación privada
- Fundación
- 2000
- Especialidades
- Regulatory and Scientific Strategy, Life-Cycle Outsourcing, Medical and Scientific Writing, Pharmacovigilance, Global Submissions, Paediatric Development Plans y eSubmissions and RIM
Ubicaciones
Empleados en ASPHALION
Actualizaciones
-
📌 EVENT | MEDICA 2024 🚀 That’s a wrap on MEDICA - Leading International Trade Fair 2024!! 🙌🏽 Thank you very much to everyone who came by and paid us a visit! As always, such an amazing event to catch up with clients, network and meet so many new people and opportunities. 😊 Can’t wait to see you again next year! 📧 Contact us! [email protected] https://bit.ly/3O9LhRw #MEDICA2024 #Event #MedicalTechnology #MedicalDevice #MedicalDevices #DispositivosMédicos #HORIZON #EUfunded #SBR #SmartBoneRegeneration #EChiLiBRiST #METHYLOMIC #RA #RegulatoryAffairs #MeetTheExpert #WeAreAsphalion #WeCare #KnowledgeFromExperience SmartBoneRegeneration METHYLOMIC_EU EChiLiBRiST Talyta, María, David, Oriol, Fran, Josefa, Diego
-
🚨 NEWS | Asphalion Highlights summary from the Clinical Data Publication (Policy 0070) Step 2 EMA Webinar 🆕 Today, the European Medicines Agency (EMA) has held an insightful #webinar to discuss the upcoming step 2 implementation of #ClinicalData Publication activities under #Policy0070. 🔑 Points presented during the webinar: - All applications that receive a positive or negative #CHMP opinion—including #MAAs, extensions of indications, and line extensions—from Q2 2025 (provisionally April) onward will be included in this initiative, regardless of the status of the active substance. - Withdrawn applications will be included. - This step will exclude #generics, #hybrids, and #biosimilars. - For legacy #procedures, Access-to-documents requests related to #clinicaldata will trigger the #ClinicalDataPublication procedure. ▶ At ASPHALION, we can support your #RegulatoryNeeds related to Policy 0070: - Pre-submission interaction support. - Redaction criteria definition. . Management of Personal Protected Data (#PPD) and Commercial Confidential Information (#CCI). - Preparation of Redaction Proposal Package and Final Package, along with #eCTD #publishing and #submission. ↪️ Have a look at the timeline that ASPHALION experts have prepared for you to take into consideration the steps and timing regarding clinical data publication for new @MAA. At the same time, You can also find out more about our expertise on #ClinicalDataDisclosure here⏩ https://bit.ly/3Wdwvgo 📧 Our experts are ready to help! Contact us to learn more about how we can assist you in being compliant with the upcoming implementation: [email protected] #EMA #EU #Europe #Medicines #Step2 #ClinicalDataPublication #Transparency #Regulatory #RA #RegulatoryAffairs #WeAreAsphalion #WeCare #KnowledgeFromExperience https://bit.ly/40Mb4Hd
-
-
📌 EVENT | MEDICA 📢 Last hours to discuss your #MedTech #Regulatory needs with us at #MEDICA2024! 📍Booth C77 Hall 13 ☕️ Come by, grab a coffee and let´s discuss about how ASPHALION can help you! 📧 [email protected] #MEDICA2024 #MedicalDevices #MDR #IVDR #FDA #RA #RegulatoryAffairs #QMS #RA #WeAreAsphalion #WeCare #KnowledgeFromExperience Talyta, Oriol, María, Fran, David, Diego, Josefa
-
-
📌 FREE WEBINAR | How to best interact with a Notified Body for a successful MDR Application 📅 November 27 🕒3:00 pm 💻 Online 💡 Explore the intricate processes involved in the qualification and classification of medical devices (MDs) under the Regulation (EU) 2017/745 or MDR 🔝 Join ASPHALION expert Koldo García de Acilu Gámiz and BSI expert Pilar Maldonado as they share their expertise on the topic. 🔗 Register here: https://bit.ly/3NqVY1W https://bit.ly/3YozzbM #Webinar #FreeWebinar #MedTech #NotifiedBody #OrganismoNotificado #NotifiedBodies #BSI #Asphalion #MD #MedicalDevice #EURequirements #Europe #MDR #MeetTheExpert #RA #RegulatoryAffairs #WeAreAsphalion #WeCare #KnowledgeFromExperience
-
-
📌 AWARENESS | World Diabetes Day 2024 🌍 Today, on World Diabetes Day 2024, we unite in our commitment to raise awareness and support the well-being of those living with diabetes. With over 537 million people affected globally, diabetes continues to have a profound impact on individuals, families, and communities. ↪️ This year’s theme, “Diabetes and Well-Being,” underscores the critical importance of ensuring access to comprehensive care and support for people with diabetes, empowering them to live well. ↪️ At ASPHALION, we’re #committed to improving health and #wellbeing for all. In recognition of #WorldDiabetesDay, we highlight not only the importance of #awareness, but also #prevention and management. Our #AsphaWellbeing program reflects this dedication, supporting our employees' mental, physical, and emotional #health. 🤝 Our mission is clear: working alongside our clients and partners to create innovative solutions that drive better health for everyone. https://bit.ly/3O5vfIq #WorldDiabetesDay #Diabetes DiabetesAndWellBeing #HealthInnovation #HealthAndWellbeing #Asphalion #DiabetesCare #Wellbeing #AsphaWellbeing #RA #RegulatoryAffairs #WeAreAsphalion #WeCare #KnowledgeFromExperience
-
-
📌 EVENT | MEDICA 2024 📍 Düsseldorf 📆 November 11-14 🚀 DAY 3 at MEDICA - Leading International Trade Fair in #Düsseldorf!!!! ☕ Our team is still at #MEDICA in Düsseldorf and ready to answer any questions you may have—let’s chat over a coffee! We're offering free coffee at our booth, so stop by and grab a cup while we talk! 😉 🤝 Stop by at booth C77 in Hall 13 to discuss your #MedTech projects with our experts Oriol Penon, PhD, Talyta Carteano, Josefa Güiles Muñoz, María Liñares Beiras, David Escudero, Fran Rodríguez Gómez, PhD and Diego Sanoja Garcia! 🧩 We can't wait to connect with you! 📧 You can also schedule a meeting with us: [email protected] https://bit.ly/4f7PDEL #MEDICA2024 #Event #MedicalTechnology #MedicalDevice #MedicalDevices #DispositivoMédico #RA #RegulatoryAffairs #MeetTheExpert #WeAreAsphalion #WeCare #KnowledgeFromExperience
-
-
▶ The PragmaTIL trial aims to optimize treatment of #cancer patients with Tumour-Infiltrating Lymphocytes Adoptive #CellTherapy (TIL-ACT) and substantially expand and improve the #clinical implementation of this treatment modality in academic hospitals. ▶ Vall d'Hebron Institute of Oncology (VHIO) leads work package 6 of the project about scientific coordination, PM and communication. At ASPHALION, we are in charge of the #Regulatory work package, focused on the submission of the #clinicaltrial and the #safety management plan. 📧 For further information, you can contact us at: [email protected] ➕ To learn more about #PragmaTIL, please visit: www.pragmatil.eu #CTIS #Safety #RA #HORIZON #EU #RegulatoryAffairs #EquitableAccess #Patientcentered #DisruptiveInnovativeTherapy #TILs #Interleukin #WeAreAsphalion #WeCare #KnowledgeFromExperience
🔬 The Vall d'Hebron Institute of Oncology (VHIO) leads the scientific coordination, project management, and communication efforts of #PragmaTIL. By setting clear direction, aligning partners, and upholding high standards at every milestone, WP6 efforts are driving the project forward. 💊 In addition, through strategic collaboration with other consortia, we aim to maximize the impact of #TILtherapy and accelerate its potential in cancer treatment. The goal is to engage with the scientific community, patients, and society to share valuable insights and knowledge. 🇪🇺 Project funded by the EU #HorizonEU research and innovation programme Gustave Roussy The Netherlands Cancer Institute CCIT-DK - National Center for Cancer Immune Therapy of Denmark Unicancer Seintinelles Fundación ”la Caixa” ASPHALION Karolinska Institutet Sheba Medical Center, Tel Hashomer Innovandum BCN HEALTH
-
-
📌 siNPAIN | Fifth progress meeting ↪️ The #EUfunded #HORIZON project siNPAIN is holding its 5th progress meeting in #Marseille, France. ↪️ Each partner is providing a summary of the status of their respective #workpackages (WPs). As the #regulatorypartner and leader of WP6, ASPHALION’s expert Joan Cabellos has presented an overview of our achievements, ongoing tasks, and future plans, alongside updates from the other project partners. ↪️ The project, which aims to develop a new #therapy that will combine #RNA technology, nanocarriers and an improved hyaluronic acid-based knee viscosupplement (IA-HA), is currently at month 31 of the 54-month timeline. 🔗For more information about the siNPAIN project check out the website here: https://lnkd.in/dEYYe_CB 📧 For additional information and for all your EU-funded projects, you can also contact us at: [email protected] https://bit.ly/4fKW0O9 #siNPAIN #Osteoarthritis #EU #RA #roadmap #RegulatoryAffairs #MeetTheExpert #WeAreAsphalion #WeCare #KnowledgeFromExperience
-
-
📌 DÍA 2 | XIII Jornadas Nacionales de Farmacovigilancia 📍 Oviedo, 12-13 de noviembre 🔝 Segundo día de las XIII Jornadas Nacionales de #Farmacovigilancia en #Asturias, organizadas por la Agencia Española de Medicamentos y Productos Sanitarios. 💡¿Estáis preparado para todos los #PSURs que hay que elaborar durante 2025? ¡Asphalion puede ayudaros a cumplir con las fechas establecidas por la European Medicines Agency (#EMA)! 👋🏽 Venid a ver a nuestras expertas en #farmacovigilancia Sonia López, Alicia Garrido, Laura Eder y Carola López al stand 4 para ver cómo podemos ayudaros. 📩 ¿Necesitas más información o te gustaría agendar una reunión? Escríbenos: [email protected]. #SeguridadDeMedicamentos #AEMPS #SaludPública #JornadasFarmacovigilancia #PV #Pharmacovigilance #Safety #Vigilance #FV #VigilanciaDeDispositivosMédicos #RA #RegulatoryAffairs #WeAreAsphalion #WeCare #KnowledgeFromExperience https://bit.ly/4hBgk6s
-