DEKRA Certification GmbH | The first IVDR Notified Body

October 15, 2019

Two months after being designated as the third Notified Body (NB) under the Medical Devices Regulation (MDR), Dekra Certification GmbH was annouced last week by the European Commission (EC) as the first NB to be designated under the EU In Vitro Diagnostic Regulation (IVDR).

Stakeholders Update Meeting

October 14, 2019

Last Friday, Stakeholders Update Meeting took place in Madrid and was a great success!

MDR | SSCP: a guide for manufacturers and notified bodies

October 10, 2019

With the entry into force of the new Medical Devices Regulation (2017/745/EU, “MDR”), many new requirements to be met by the manufacturers have been established.

January 2020 | EDQM will require eCTD submissions for all applications

October 8, 2019

As published in the Electronic submissions for CEP applications Revised Roadmap 2016-2020, from January 2020, EDQM will require eCTD submissions for all applications including requests for revisions and renewals (except for TSE only submissions and for submissions for substances for veterinary use only). 

Our 5th Newsletter is out now!

October 3, 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. Subscribe to our newsletter and become an expert in Regulatory Affairs!

Health Canada: New Deadline for DMF in eCTD Format

October 3, 2019

In September 2019, Health Canada announced that 1st January 2020 is the new deadline for all new Master Files as well as all additional information and subsequent regulatory transactions will be mandatory in eCTD format.

Sonia López – New Regulatory Affairs Associate Director at Asphalion

October 2, 2019

Asphalion’s Board of Directors announce Sonia López as new Regulatory Affairs Associate Director of the company.

WEBINAR – Document Management Systems: ¿qué debes saber?

October 2, 2019

No pierdas nuestro próximo webinar que tendrá lugar el día 7 de Noviembre 11 – 12 horas. 

September is World Alzheimer’s Month

September 27, 2019

September is World Alzheimer’s Month and this year Asphalion wants to talk about it.

Medical Devices Regulation (2017/745/EU, “MDR”)

September 23, 2019

The new Medical Devices Regulation (2017/745/EU, “MDR”) brings EU legislation in pace with technical advances, innovations in medical science, and progress in law making.

World Alzheimer’s Month: reduce your risk of developing dementia

September 20, 2019

September is the World Alzheimer’s Month and this year Asphalion wants to talk about it because research suggests that leading a healthy lifestyle may help to reduce a person’s risk of developing dementia later in life.

Asphalion: Promoting a Healthy Work-Life Balance

September 19, 2019

Asphalion believes in helping employees find a little balance in their workday and we have measures to help reconcile work with private and family life.

Digital transformation and pharmacovigilance: technology update

September 17, 2019

Today, our experts Núria Romero, Sonia López, Nuria Cabello and Bernat Autonell participated in the workshop “Digital transformation and pharmacovigilance: technology update” organized by Arithmos, Asphalion and Oracle Health Sciences.

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!

Summer – We do not close in August!

August 2, 2019

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!

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!