CAMD Implementation Taskforce

December 7, 2017

Key issues to be addressed as part of the implementation of MDR and IVDR

Become an FDA expert! Join next Asphalion seminars on US Regulatory Affairs

November 28, 2017

23rd January 2018 in Munich & 7-8th June 2018 in Barcelona

The New EudraVigilance Human System is now live!

November 23, 2017

The system was launched yesterday with enhanced features for the reporting and analysis of adverse reactions

Asphanews November 2017

November 17, 2017

Keep updated on the latest news of Asphalion and pharma sector!

EU agencies relocation will be decided on 20th November 2017!

November 17, 2017

European Medicines Agency (EMA) and the European Banking Authority (EBA) are moving after Brexit

Thank you for visiting us!

November 16, 2017

Thank you everyone for visiting Asphalion stands at CPhI 2017 in Frankfurt and GPRAS 2017 in Prague

Notified Bodies re-designation under new Medical Device Regulation/In Vitro Diagnostics Regulation

November 14, 2017

26th November 2017 is the deadline for application

FDA has released tips on the submission of DMFs in eCTD format

November 11, 2017

As of 5th May 2018, Durg Master File submissions must be in eCTD format

Asphalion reinforces its potential to support advanced therapy medicinal product (ATMP) development

November 10, 2017

The recent ESCGT meeting in Berlin highlighted the recent growth and commercial potential of advanced therapies as many products arrive to market. The EMA’s recent increased activity in this area also suggests that more might be on the way

Mandatory use of eCTD format in EU procedures

November 10, 2017

Maintenance activities of MRP registrations in eCTD will become compulsory in January 2018

IL3 course on Telematic management of drugs information

November 7, 2017

Remco Munnik is participating as a speaker presenting “Impact of the implementation of ISO-IDMP standards in the pharmaceutical industry”

HIVACAR and Asphalion attended Innovation Task Force (ITF) meeting with the EMA

October 27, 2017

Terapeutic strategy of the project and the clinical trial were discussed

Asphalion attends the first general assembly meeting (GAM) of the HIVACAR consortium in Paris

October 27, 2017

HIVACAR H2020 project aims to provide a new therapeutic alternative

Asphalion and HIVACAR attend scientific and technical advice meeting with Belgian national competent authorities AFMPS/FAGG

October 27, 2017

The aim of the meeting was to support the planned Clinical Trial Application

New version of the EMA EudraVigilance to be launched on 22nd November

October 26, 2017

Improved system with enhanced features for reporting and analysis of suspected adverse reactions related to medicines

New offices in Madrid

October 20, 2017

Asphalion closer to AEMPS

We are hiring!

October 19, 2017

Are you interested in working at Asphalion? See our current job offers and apply to join our team!

New requirements on Pharmacovigilance Data Entry!

October 16, 2017

New obligations on signal management and reporting of suspected adverse reactions will apply since November 2017

Condemn any form of violence

October 3, 2017

After the events that took place this Sunday, the 1st of October in Catalonia, Asphalion wants to condemn any form of violence.

New FDA Gateway in Production Environment

September 28, 2017

Since September 18th Production FDA ESG 2nd generation is live

Asphanews September!

September 14, 2017

Welcome back! It’s time to keep updated on the latest news of Asphalion and pharma sector

World Pharmacists Day 2017

September 7, 2017

Asphalion is joining the cause on September 25th to highlight the great contributions the pharmacy profession is making to healthcare

How to include the REMS for NDAs, ANDAs and BLAs in SPL format?

September 7, 2017

FDA has just released a the guide to include them and in two years it will become mandatory

EMA has implemented a new submission form for post-authorisation measures (PAM)

September 7, 2017

Asphalion can assist you with the PAMs of your centrally authorised product!

Global Pharmaceutical Regulatory Affairs Summit 2017

August 29, 2017

Get an exclusive 25% conference discount by using Asphalion’s VIP code CQ5267ION

FDA User Fees have been reauthorized

August 22, 2017

Get an update on the FDA Regulatory Affairs by joining our webinar!

Asphalion participated in the 8th General Assembly Meeting of the iHIVARNA’s project in Paris

August 21, 2017

The meeting focused on the phase I clinical trial, the ongoing phase II clinical trial, and next actions to be taken

We are all Barcelona

August 18, 2017

Asphalion rejects violence and terrorism and wishes to give condolence to all families. We want to offer all our support in these difficult moments

Asphanews July!

July 28, 2017

Keep updated on the latest news of Asphalion and enjoy summer!

Free webinar on FDA Regulatory Affairs!

July 27, 2017

Based on the successful FDA Open Seminar conference series, we’ll host a 2 hour crash course webinar. You will hear about the latest US drug regulation news and will obtain a solid introduction into FDA Regulatory Affairs.