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!

We will be open in August and available to attend all your needs and requests as usual. Everyone here at Asphalion wishes you a wonderful and relaxing holiday season!

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

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! Today, we are celebrating reaching this milestone by having a special breakfast with all of Asphalion’s employees.

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

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.

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).

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.

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.

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

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

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).

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

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

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.

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

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

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.

The eRA Conference 2019 started today!

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

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

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

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.