News & Events
ISO-IDMP O EL CAMBIO DE PARADIGMA EN LA INDUSTRIA FARMACÉUTICA
La Agencia Europea del Medicamento (EMA) ha comenzado la implementación de los estándares desarrollados por la Organización Internacional de Normalización (ISO, del inglés International Organization for Standardization) para la identificación única de medicamentos (IDMP, del inglés Identification of Medicinal Products).
The Regulation (EU) 536/2014 comes into force mandatorily from today for all clinical trials to be initiated!
Likewise, any clinical trial initiated before today, and not considered within the CTIS Regulation, will have to transition to CTIS before January 31st, 2025.
EMA UPDATE! DAY ZERO FOR MEDICAL LITERATURE REPORTS
The European Medicines Agency (EMA) has issued a new Q&A for marketing authorization holders (MAHs) to clarify timelines regarding identifying individual case safety reports from physical/hard copy local journals.
ASPHALION’S NEW CORPORATE VIDEO IS OUT!!
We are excited to announce the release of our new corporate video!
We encourage you to take a look at it! The video aims at providing you with an insight into Asphalion’s added value as an international Regulatory, Scientific & Safety Consulting in Life Sciences, showcasing our company, our services and our strengths.
Internal Audit of QMS according to ISO 13485 / UK regulation/ MDSAP / US FDA
At Asphalion we count with Lead Auditors with an extensive track record and experience in the annual review of the QMS suitability and efficiency.
RBDCOV | COVID-19 vaccine trials with immunocompromising conditions launched in Turkey
All the volunteers are adults affected by different pathologies or immunosuppressive conditions whose immune system may be less responsive to vaccines.
New MDCG guidance documents under the MDR and IVDR
The new fees will not come into effect until next June, so that the fees established on December 2022 remain still valid.
New European Project | NABIHEAL in biomaterials for complex wound healing
The meeting provided the opportunity to interact in person with all the consortium partners and establish the first collaborative activities to ensure timely delivery of the project milestones.
Search or filter
