MDR corrigendum | Manufacturers of Class I MD may have 4 years more to meet the regulation’s standards

January 13, 2020

UPDATE: The corrigendum for the EU’s Medical Devices Regulation (MDR) granting manufacturers of Class I devices upclassified under MDR a four-year transitional period has been approved and published.

Formatted Letter Template | No longer maintained by EMA

January 9, 2020

As from January 1st 2020, the Formatted Letter Template used in CP applications is no longer maintained by EMA.

Asphalion team wishes you a Merry Christmas and a Happy New Year

December 19, 2019

2020 is very special for us as we will celebrate the 20th Anniversary of Asphalion. Thank you for being part of it!

May 2020 | Only a few months remain for DoA of the new MDR

December 4, 2019

May 2020 is round the corner and therefore, only a few months remain for date of application (DoA) of the new medical device regulation (MDR).

AsphaNews | Last newsletter of the year 2019 🌠

December 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!

Asphalion attended the second edition of the “Forum d’Empreses de l’ámbit farmacèutic – sanitari“

December 2, 2019

Last week Asphalion attended the second edition of the “Forum d’Empreses de l’ámbit farmacèutic – sanitari“, organised by the Facultat de Farmàcia I ciències de l’alimentació de la Universitat de Barcelona.

Marcos Fernández, New Regulatory Affairs Associate Director at Asphalion

November 26, 2019

Communication from the Board of Directors: Marcos Fernández, New Regulatory Affairs Associate Director at Asphalion

Asphalion Walks for La Marató de TV3!

November 19, 2019

Yesterday, Asphalion’s values (commitment flexibility passion and teamwork) were demonstrated in a 17 km hike organized and walked by members of the company who traveled with family & friends from our offices in Barcelona to Sant Cugat del Vallès.

n-TRACK Project Review Meeting

November 13, 2019

Last week, our colleagues Marta Rayo Lunar and Marta Morales attended the n-TRACK Project Review Meeting in Cambridge to discuss the project progress with all the partners.

Q&A document on the implementation of the MDR and IVDR

November 12, 2019

The EMA has recently revised the Q&A document that provides practical considerations concerning the implementation of the MDR and IVDR.

Graphene Connect on MedTech and Diagnostic Technologies

November 7, 2019

Yesterday, November 6, Dominique Monferrer and Eduardo Garrido participated in the event Graphene Connect on MedTech and Diagnostic Technologies associated with the first Graphene for Health Investment Forum.

Brexit | Very interesting and productive day!

November 4, 2019

Last week, Lidia Cánovas and Nuria Romero participated in the seminar “Els efectes del Brexit en el sector Farma”.

La Castanyada & Halloween in Asphalion

October 31, 2019

Asphalion is celebrating both events on the same day. Do you celebrate these festivities in your company too? Trick or Treat?

Training session on regulatory approach of ICH Q12

October 30, 2019

Yesterday, Consol Bozzo Mulet and Daniel Langa García gave a training session on regulatory approach of “ICH Q12: Control de cambios. Consideraciones técnicas y regulatorias en el ciclo de vida de los productos farmacéuticos.”.

Asphalion in the 27th ESGCT Annual Congress

October 23, 2019

Today Christopher Mann, Joel Montane and Oriol Penon are attending the 27TH ESGCT Annual Congress in Barcelona.

EudraCT | Clinical trials conduted in the EU need to be registered with the database

October 22, 2019

In June 2019, the EC, the EMA and the HMA co-signed a letter reminding all sponsors of clinical trials conducted in the EU of their obligation to make summaries of results of concluded trials publicly available in the EudraCT.

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.