SME Office – Annual Report 2018

June 12, 2019

he SME Office has published its annual report summarising its experience with small and medium-sized enterprises (SMEs) during the year 2018.

Bases de datos de Farmacovigilancia: ¿qué debe saber IT?

June 11, 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. 

Are you ready to enter the transformed landscape in Pharmacovigilance?

June 6, 2019

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.

Drug Device Combinations: Consultation on draft guideline on quality requirements

June 4, 2019

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.

#SaveTheDate: 10th of October

June 4, 2019

This exclusive event will guide you through the latest regulatory developments for clinical and post-market studies comparing US and EU requirements.

Our #3 Asphanews is out now!

June 4, 2019

Make sure you do not miss out on the news in our #3 Newsletter!

CMC Solutions

May 30, 2019

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.

Fighting diabetes: TERMIS EU 2019 in Rhodes

May 27, 2019

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).

TÜV Süd, new Notified Body designated to issue CE Mark certifications under EU MDR

May 24, 2019

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.

#AsphalionShare: EMA workshop presentations

May 23, 2019

Recently published presentations and recordings of the EMA workshop on support to quality development in early access approaches, such as PRIME and breakthrough therapies.

The eRA Conference 2019 started today!

May 22, 2019

The eRA Conference 2019 started today!

Gene therapy for SCID-X1

May 20, 2019

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.

EU measures in support of generic pharmaceuticals producers

May 17, 2019

The EU adopts regulation to promote the competitiveness of EU producers of generic medicines and biosimilar products.

Are you attending the 14th #WATRMC in London?

May 16, 2019

Are you attending the 14th World Advanced Therapies & Regenerative Medicine Congress in London? Take a moment to visit Asphalion at booth 43.

Asphalion is companionship

May 15, 2019

Asphalion is passion, flexibility, quality, commitment…but above all, Asphalion is companionship. Last week, the Asphalion’s annual team building took place in Barcelona.

First patients treated with CRISPR

May 13, 2019

The University of Pennsylvania in Philadelphia, USA, reported that the first two patients in a cancer immunotherapy trial have received CRISPR-edited medicinal product.

Free Webinar to guide you through the process of the Centralised Procedure

May 13, 2019

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).

Asphalion wants to be your regulatory partner for Medical Devices

May 6, 2019

Our team provide comprehensive support during development, validation, certification and manufacturing of Medical Devices (MD) in Europe and the United States.

ISGlobal and CRG Career Charla

May 2, 2019

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.

1st Asphalion Open Doors: Latest Insights on Scientific & Regulatory Affairs

April 30, 2019

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.

ATMPs News

April 29, 2019

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.

Q&A published on how to handle eCTD for ASMF submissions

April 29, 2019

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: [email protected]

Critical projects require experts

April 24, 2019

Asphalion and Dora Wirth Languages are organizing a webinar on 16th May 2019 to guide you through the process of the Centralised Procedure (CP).

Sant Jordi’s Day

April 23, 2019

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…

Invasive Therapies Meeting by EHDN Invasive Therapies Working Group

April 17, 2019

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).

CAR T-cell therapy

April 16, 2019

Are you working in CAR T therapies, advanced therapies or personalised medicine and would like additional regulatory support? Please contact Asphalion at [email protected]

Brexit: Article 50 extension

April 15, 2019

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 participates at the 3rd Annual Meeting of the Myocure project

April 10, 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.

World Health Day 2019

April 8, 2019

Yesterday was the World Health Day!

Dominique Monferrer in the Eurecat Conference

April 5, 2019

Dominique Monferrer, Asphalion’s Medical Devices Expert, was invited by Eurocat to give a talk on “Aspectos regulatorios en el desarrollo de productos sanitarios”.

EMA has published a Q&A document to answer Brexit questions

April 1, 2019

In order to prevent medicine shortages due to the United Kingdom’s withdrawal from the EU (Brexit), EMA has published a questions-and-answers document for patients, healthcare professionals and the general public.

Asphalion attended CardioReGenix H2020 project kick-off meeting

March 27, 2019

The EU has awarded a grant of 15€ million for a research programme to support new gene therapy approaches for the treatment of heart disease. This 5-year project is being coordinated by Professor Marinee Chuah from the Free University of Brussels and includes 13 partners including Asphalion.