Marcos Fernandez is attending the LORENZ userBridge Conference 2019

September 17, 2019

Today Marcos Fernandez, Regulatory Affairs Manager at Asphalion, is attending the LORENZ userBridge Conference 2019 in Greece.

Luxturna: the first licensed gene therapy for rare inherited eye disorder is recommended by NICE

September 5, 2019

A draft NICE guidance recommends Voretigene Neparvovec (also called Luxturna) to treat people with vision loss caused by inherited retinal dystrophy from confirmed RPE65 gene mutations who have enough viable retinal cells.

FDA aims to start deactivating outdated drug listing records to ensure the patient safety

August 28, 2019

The Food and Drug Administration (FDA) announced its intention to clean the drug listing database from outdated and uncertified records.

New study shows EMA and FDA aligned on marketing authorisations

August 21, 2019

The FDA and the EMA are aligned in more than 90% of marketing authorizations (MA) for new drugs, according to a new study from EMA and FDA officials comparing 107 new medicine applications at the two agencies between 2014 and 2016.

Join our team!

August 19, 2019

We do not close in August and we are always looking for passionate, ambitious and enthusiastic people to join the Asphalion Team.

Our 4th Asphanews is out now!

August 6, 2019

Take a quick look at our latest newsletter and keep up to date with the latest news and events on the regulatory affairs and pharma sector!

Vicente Tur, New Regulatory Affairs Director at Asphalion

July 31, 2019

Asphalion’s Board of Directors announce Vicente Tur as new Regulatory Affairs Director of the company.

Asphalion is commitment!

July 24, 2019

Last week, Aspahlion decided to collaborate with Aspen Pharmacare Spain in their campaign to help the the Fundació Banc dels Aliments de Barcelona in its food collection campaign “El Hambre No Hace Vacaciones”.

Asphalion’s LinkedIn community now has 10,000 followers!

July 16, 2019

Asphalion’s LinkedIn community now has 10,000 followers! Today, we are celebrating reaching this milestone by having a special breakfast with all of Asphalion’s employees.

New QRD template released on EMA website

July 11, 2019

At the end of June 2019 EMA published new QRD template (v10.1) for centrally authorized products.

DMFs in Health-Canada

July 10, 2019

From 1st September 2019, all new Master Files submitted to Health-Canada must be in eCTD format, in addition, when converting MFs from non-eCTD format to the eCTD format, the entire MF must be provided in the first eCTD transaction, as a baseline requirement.

Spanish Notified Body 0318 Applies for EU MDR Redesignation

July 9, 2019

Last week, the Spanish Agency of Medicines and Medical Products (AEMPS) announced it’s notified body (NB) 0318 has begun the process to become designated as NB under the European Union’s medical device regulation (MDR).

MDR – Less than one year to go

July 4, 2019

On 6th June 2019 COCIR, the European trade association representing the medical imaging, radiotherapy, health ICT and electromedical industries, has published a document summarizing the current status in MDR implementation, which still shows little progress in a number of critical aspects.

Healthy Week

July 3, 2019

In Asphalion, we have always been focused on helping to create a healthy, supportive, and safe work environment. That’s why we promote health and wellness programs to help and encourage our workers to develop healthy lifestyle practices.

Asphalion in MedTech Summit 2019

June 21, 2019

On Monday and Tuesday, Lidia Cánovas and Dominique Monferrer participated in the MedTech Summit 2019.

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

June 21, 2019

No pierdas nuestro próximo webinar que tendrá lugar el día 28 de Junio de 11 – 12 horas.

News on Medical Devices

June 17, 2019

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).

Asphalion Open Doors was amazing!

June 14, 2019

The first edition of Asphalion Open Doors took place last 7th June in Barcelona!

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.