Sant Jordi’s Day

April 23, 2019

Enjoy Sant Jordi’s Day!

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.

Regulatory Training Session on Sanitary Products

March 26, 2019

Last week, Dominique Monferrer,Scientific & Regulatory Affairs Associate Director at Asphalion, led a very successful Regulatory Training Session on Sanitary Products at AQuAS – Salut.

Asphalion and Agatha New Partnership

March 20, 2019

We are delighted and proud to announce that Asphalion signed a reselling partnership agreement with Agatha Inc., a global leading provider of Quality and Content Management cloud service.

Asphalion, partners hacia el futuro

March 19, 2019

Asphalion, partners hacia el futuro es un programa gratuito dirigido a los departamentos de IT donde nuestros expertos comparten conocimiento y aportan soluciones a los retos diarios.

10th anniversary of Andalusian Advanced Therapies Initiative

March 19, 2019

From Asphalion we want to congratulate the Andalusian Advanced Therapies Initiative for its 10th Anniversary and its excellent work.

From 4 to 8 March, the Agency is operating remotely.

March 6, 2019

From 4 to 8 March, the Agency is operating remotely. From 11 to 15 March, EMA staff will gradually move into a temporary building in Amsterdam, called the Spark building.

Asphalion opens new office in Amsterdam

March 4, 2019

We are proud to announce the opening of our new office in Amsterdam.
Our new offices are located next to the future location of the European Medicines Agency (EMA), at the World Trade Center.

Today is the Rare Disease Day! Asphalion cares!

February 28, 2019

As a Rare Disease Day’s Friend, from Asphalion we would like to show our commitment to the development of new treatments for rare diseases.

The 39th Symposium of AEFI will be there soon!

February 21, 2019

This year, the meeting will be taking place from 14-15 March 2019 at the Hotel Sants Barceló, Barcelona. We are delighted and proud to announce that Asphalion experts will actively participate in the conference.

FDA: Type III DMF mandatory from 5 May 2020

February 20, 2019

FDA updated the guideline for Providing Regulatory Submissions in Electronic Format to reflect that the requirement for Type III drug master files (DMFs) to be filed electronically takes place 60 months after May 5, 2015.

EMA released validation checklist for initial MAA of the Centralised Procedure (CP)

February 19, 2019

Currently, validation issues occur in 90% of initial marketing authorisation applications (MAAs).  These validation issues create additional workload for companies and potential delays at a critical moment for the timely start of the procedure.

Brexit, is the Pharmaceutical Industry ready for Brexit?

February 18, 2019

There is few time left until end of March and there are still quite some uncertainties with regards to the Brexit.
Asphalion can assist with the RMS transfer and provide EU QPPV, PSMF establishment and SME registration within the EU.

Asphalion & Magic Line Sant Joan de Déu

February 15, 2019

Next 24/02, Asphalion joins the solidarity march for the Hospital Sant Joan de Déu: La Magic Line. Our team AsphaLion will walk 20 km to help the most vulnerable people in #Barcelona!

Innovation and Digital Transformation in Pharma & Medical Device Vigilance

February 13, 2019

Núria Romero Carol and Sonia López Sánchez in the workshop  “Innovation and Digital Transformation in Pharma & Medical Device Vigilance: Regulatory and Technology Update”

Health Canada expands the scope of regulatory activity types for mandatory use of eCTD

February 11, 2019

Asphalion has extensive experience with publishing in eCTD format. If you have any question, please contact us!

Update on Serialization

January 31, 2019

AEMPS establishes recommendation[1] for the implementation of safety features in medicinal products for human use, which will be applicable from 9 February 2019.

II Hard Reg Cafè by CataloniaBio & HealthTech Regulatory Affairs Workgroup

January 30, 2019

Next Monday, 4 February, will occur the second networking coffee meeting.

Pharmacovigilance System Audit

January 29, 2019

Do you want to audit your pharmacovigilance system?

Regulatory Affairs Training

January 29, 2019

Yesterday, our experts Lidia Cánovas and Oriol Penon gave two training sessions at CIC bioGUNE on ‘Regulatory Introduction for medical devices’ and ‘Regulatory Introduction for medicinal products’, respectively.

Speaker Announcement – DIA Event

January 28, 2019

We are excited to announce that Remco Munnik, our Regulatory Information Director, will be speaking in the DIA’s Regulatory Submissions, Information and Document Management Forum (USA).

Centralised Procedures News

January 25, 2019

EMA has announced a delay in replacing the Formatted Table Template with the eSubmission Gateway Delivery file.

Webinar de eCTDmanager Avanzado

January 24, 2019

Stay Tuned! El 29 de enero Asphalion llevará al cabo un webinar sobre eCTDmanager Avanzado para administradores IT. (edición en español)

News in Medical Devices

January 23, 2019

Upclassification of substance-based Medical Devices under MDR 2017/745

DIA Europe 2019

January 23, 2019

5-7 February – Vienna, Austria