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.

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.

Pharmacovigilance System Audit

January 29, 2019

Do you want to audit your pharmacovigilance system?

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)

DIA Europe 2019

January 23, 2019

5-7 February – Vienna, Austria

News in Medical Devices

January 23, 2019

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

New office in Barcelona

January 18, 2019

Asphalion is starting a very special 2019 and we want to share this special moment with all of you.

The Lapse in Funding affects activities of FDA

January 11, 2019

During the lapse period, the agency will be continuing only vital activities, to the extent permitted by the law, that are critical to ensuring public health and safety in the United States.

Centralised Procedures News – Delay!

January 10, 2019

From 1st February 2019, the Formatted Letter Template for Centralised Procedures will no longer be needed. – DELAY!

Save the date: 31.January -1.February 18th Regulatory and Scientific Affairs Conference

January 8, 2019

If you are interested in starting the year by getting fully informed about the activities and future plans in Regulatory in Europe, Medicines for Europe´s conference is the best place.

MHRA: if there’s no Brexit deal

January 7, 2019

To start the year, MHRA has published a statement on 3rd January in case of a no deal scenario between UK and EU.

Merry Christmas and a Happy New Year

December 19, 2018

Asphalion team wishes you a Merry Christmas and a Happy New Year, filled with happiness and success!

Revised EDQM guideline on requirements for revision/renewal of CEPs

December 14, 2018

In January 2019, the revised EDQM ‘Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs’ will enter into force.

Are you looking for a Horizon 2020 regulatory partner?

December 12, 2018

Deadlines are fast-approaching, Asphalion can be part of your consortium.

Atlas Molecular Pharma receives EMA and FDA ODD for CEP with Asphalion support

December 11, 2018

Atlas Molecular Pharma, a company specialized in the discovery and development of first-in-class, innovative therapeutics for the treatment of Rare and ultra-Rare Diseases, announced that its candidate drug Ciclopirox (L2.7.D7) was granted the ODD status on January 17th 2018 by the European Commision and on 17th April 2018 by the FDA.

Life isn’t all about work!

December 5, 2018

Yes, you can ask: “What is the relationship between Henri de Toulousse-Lautrec and Asphalion?” or “Is Asphalion changing its core business to Regulatory Affairs from Art Consultancy?”

Gran acogida del primer Open Seminar sobre Transformación Digital organizado por Asphalion y EXTEDO

December 4, 2018

El evento tuvo lugar en Barcelona y Madrid, y contó con más de 100 participantes de 50 empresas distintas, todas ellas con sede en España. ¡Gracias a todos por vuestra participación!

I Curso de Biomarcadores en Reumatologia

November 23, 2018

Last weekend, Asphalion took part in the I Curso de Biomarcadores en Reumatologia.

Eudravigilance System

November 22, 2018

The new Eudravigilance system has been in operation since 22nd November 2017.

EMA public consultation

November 20, 2018

EMA published for public consultation a guideline on quality, non-clinical and clinical aspects of medicines containing genetically modified cell.

News in paediatric pharmacovigilance

November 16, 2018

EMA made public the new good pharmacovigilance practice (GVP) chapter IV that offers an integrated view of pediatric pharmacovigilance.

Asphalion is part of one of the new working groups of AEFI

November 5, 2018

Do not miss the latest news from eCTD, xEVMPD and all electronic formats.