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

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.

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

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

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.”.

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

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.

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).

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

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.

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). 

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!

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.

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

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

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

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.

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

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.

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

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.

The Food and Drug Administration (FDA) announced its intention to clean the drug listing database from outdated and uncertified records.

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.

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

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.