A new version of the MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES has recently been published by the EU Commission (version 1.22, 05-2019).
Si necesitas saber qué tipos de bases de datos existen para Farmacovigilancia y cómo garantizar las seguridad, integridad y trazabilidad de los datos, no pierdas nuestro próximo webinar que tendrá lugar el día 28 de Junio de 11-12 horas.
On 12 & 13 June, Sónia Lopez, Qualified Person Responsible for Pharmacovigilance at Asphalion, and Núria Cabello, Senior Drug Safety Officer at Asphalion, will be participating in the International Pharmacovigilance Day conference organized by LS Academy.
On 03.06.2019 the European Medicines Agency released a draft guideline on the quality requirements for medical devices (MD) in human medicines that include a MD for a 3-month public consultation, as part of a series related to the European’s medical devices regulation.
We can either provide you a full integrated support (from lab to market) or a tailored support as per you specific needs, at any stage of development or during post-approval lifecycle of Human Medicinal Products.
16 countries, 36 among universities, SMEs and research institutions across Europe, Israel and the United States are the protagonists of the EU-H2020 funded research that is being presented today at the European Chapter Meeting 2019 of the Tissue Engineering and Regenerative Medicine International Society (TERMIS).
On Wednesday, the Germany-based company TÜV Süd became the second notified body (NB) to be designated and notified under the EU Medical Devices Regulation (MDR), which goes into effect next May.
Recently published presentations and recordings of the EMA workshop on support to quality development in early access approaches, such as PRIME and breakthrough therapies.
A new gene therapy study in New England Journal of Medicine reports positively on the use of a self-inactivated lentivirus supplemented by an insulator and a codon-optimised human common γ chain gene to treat SCID-X1 disease.
The University of Pennsylvania in Philadelphia, USA, reported that the first two patients in a cancer immunotherapy trial have received CRISPR-edited medicinal product.
Don’t forget! On 16th May, Asphalion and Dora Wirth Languages will hold a free webinar to guide you through the process of the Centralised Procedure (CP).
Our team provide comprehensive support during development, validation, certification and manufacturing of Medical Devices (MD) in Europe and the United States.
Last week, our experts Vicente Tur and Oriol Penon participated in the ISGlobal & CRG Career Charla, a series of events co-organized by Centre for Genomic Regulation and ISGlobal aiming to inform pre- and postdoctoral researchers about the career options and possibilities inside and outside of academia.
The Asphalion Open Doors is an unique event organized by Asphalion in collaboration with its partners. This event is free and will provide a structured introduction to all important aspects of Scientific & Regulatory Affairs world.
In the lead up to the imminent FDA opinion on the biologics license application (BLA) for Novartis’ gene therapy Zolgensma for the treatment of spinal muscular atrophy (SMA), the financial media company and magazine Forbes has published an interesting editorial on the controversial issues surround the pricing and reimbursement for ATMPs.
On the eSubmission website a Q&A document has been published on how to handle eCTD for Active Substance Master Files (ASMFs). Asphalion is supporting a large number of ASMF submissions. If you are interested in support, please contact us at: eCTD@asphalion.com
Saint Jordi’s Day is one of the most original celebrations in Catalonia and takes place on 23 April. This popular festival combines culture and romanticism. On this day, it is custom for couples to exchange gifts…
Next week, our Scientific & Regulatory Affairs Associate Director Christopher Mann will be participating in the Invasive Therapies Meeting organised by European Huntington’s Disease Network (EHDN) Invasive Therapies Working Group, in collaboration with SCHD (Stem cells for HD).
On 5 April, Theresa May asked EU for Brexit extension and on 11 April, the EU agreed to a further extension of the date for the UK’s withdrawal from the EU. The extension will last as long as necessary and, in any event, no longer than 31 October 2019.
Asphalion participated in the 3rd Annual Meeting of the H2020 project MYOCURE, the 28th and 29th of March at the Ruprecht-Karls-Universität, in Heidelberg, Germany.