AsphaNews – Special Edition FDA

June 26, 2015

Read about the latest news regarding the FDA

Compliance with Pharmacovigilance legislation

June 26, 2015

Check our video to know everything you have to do before July 21st 2015!

Quality control of Article 57 data: electronic notifications

June 25, 2015

EMA offers Gateway user organisations the possibility to test the receipt of the 3rd acknowledgment in the External Compliance Testing environment as of 1 July 2015

Our Regulatory Information Director attended the EU ISO IDMP Task Force meeting

June 19, 2015

ISO IDMP must be implemented before July 2016.

eCTD news

June 12, 2015

Be informed of the upcoming critical regulatory changes on the next two months in Europe and FDA.

EMA publishes updates to product information templates for all medicines for human use

June 11, 2015

Changes will enhance presentation of information for patients and healthcare professionals

AsphaNews June 2015

June 9, 2015

Read about the latest developments in the dynamic world of Drug Development, Regulatory Affairs and PhV.

EMA released dedicated webpage for ISO IDMP

June 9, 2015

The Agency and the EU Regulatory Network are pursuing an open dialogue with industry to discuss aspects of implementing the ISO IDMP standards in the EU.

ASPHALION presents White Paper on Biosimilars

May 14, 2015

ASPHALION has been working for 10 years in biotech projects and has become one of the leading regulatory services companies for Biologicals and Advanced Therapy Medicinal Products.

Asphalion attended AEFI 2015 (12- 13/06 – Barcelona, Spain)

May 12, 2015

During the Symposium we taught 3 workshops.

ASPHALION and NextDocs partner to expand enterprise content management footprint in Spain

April 27, 2015

The alliance allows to effectively manage submission content, mitigate compliance risk and bring products to market faster.

Asphalion celebrates Saint George’s Day with roses from the Vicente Ferrer Foundation

April 23, 2015

The team received fair trade roses to celebrate “La Diada de Sant Jordi”.

Asphalion’s Open Seminar 2015: FDA Road to Success

April 1, 2015

The Seminar will take place next 27 May 2015 in Barcelona.

ASPHALION attended DIA’s EuroMeeting, 13 – 15 April 2015, Paris

March 30, 2015

ASPHALION was at booth 3.D14 of DIA’s 27th Annual EuroMeeting in Paris.

Asphalion is a proud member of Euro Pharma Bridge

March 14, 2015

Your best gateway to the European market!

We are sponsoring the eRA 2015 eRegulatory Affairs Conference (01-02 July 2015, Munich, DE)

February 24, 2015

Next Generation of Regulatory Information Management will be the motto of eRA 2015.

Mandatory use of webportal for SmPC and PIL in Spain

February 13, 2015

As from 16 February 2015, the use of the web application for electronic entry of the Summary of Product Characteristics and Patient Information Leaflet is mandatory.

Asphalion attended the 14th EGA Regulatory and Scientific Affairs Conference (London 22 – 23/01/15)

January 22, 2015

Our Regulatory Information Director, Remco Munnik, spoke at 2 sessions.

Asphalion supported the 2014 TV3 Telethon

December 10, 2014

The 23rd edition of La Marató de TV3 was broadcasted on 14 December and focused on heart disease, one of the main causes of death worldwide and in Catalonia.

Webinar gratuito: Cómo preparar y superar una Inspección de Farmacovigilancia

December 3, 2014

Acceda al webinar sobre Farmacovigilancia que ASPHALION y EXTEDO ofrecieron el pasado mes de noviembre.

Asphalion supports the Tsemai tribe school in Keerkale, Ethiopia

November 27, 2014

Two of our team members visited the school and delivered the supplies.

First photo contest of Asphalion’s employees

November 25, 2014

These are the most outstanding photos from the contest.

Lidia Cánovas and our US Agent speakers at the Ready4Growth seminar

November 20, 2014

Ready4Growth took place on November 24 in Barcelona.

Asphanews November 2014

November 11, 2014

Read about the latest developments in the dynamic world of Drug Development, Regulatory Affairs and PhV.

EMA publishes final version of Biosimilar guideline

November 9, 2014

On 29 October 2014, EMA presented the final version of their guideline on biosimilars. This document replaces the previous guidance document of 2005, provides several clarifications and introduces one important change intended to ease global development of biosimilars.

Asphalion attended CPhI (7 – 9/10 in Paris, FR)

October 8, 2014

CPHi is one of the most important events in the Pharmaceutical Industry, mainly focused on pharma market news and trends on a global scale.

Asphalion attended BIOSPAIN 2014 (24 – 26/09, Santiago de Compostela)

September 18, 2014

Our team also attended Xacobio, a three-day walk before Biospain on the Camino de Santiago.

AEMPS: improvements in fee payment system

August 27, 2014

As from 1 October the AEMPS, will have a new bank payments gateway available so as to increase payment security and facilitate procedures.

European Comission: Notice to applicants, update of variations and renewal application forms (human and veterinary)

June 17, 2014

The Notice to Applicants, has been updated with an application form for the submission of variations and renewal.

Asphalion attended AEFI 2014 (04 – 05/06 – Madrid, Spain)

June 5, 2014

During the Symposium we taught 2 workshops.

Asphalion attended ECRD 2014 (08 – 10/05, Berlin)

May 9, 2014

Lidia Canovas, and our US Agent, Bruce Thompson were at the European Conference on Rare Diseases and Orphan Products.