AEMPS establishes recommendation for the implementation of safety devices in medicinal products

October 25, 2015

It will be applicable as of February 9, 2019

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October 25, 2015

The European Commission and Heads of Medicines Agency have agreed with the phased wise implementation of ISO IDMP.

September 29, 2015

Would you like to know what they agreed?
Our Regulatory Information Director, Remco Munnik, attended the IWG group meeting on ISO IDMP at EMA.

Asphalion and Mitelos invite you to attend the first seminar in US

September 25, 2015

With more than 20 years of experience in the European regulatory environment, our speakers will present the important steps for setting the strategy for successful European submissions.

Transparency EMA

September 23, 2015

Starting this autumn, the EMA will ask CPs Applicants to send clinical information from your registration dossier eCTD format. These new requirements are part of the Transparency Policy (Policy/0070).

Monitoring of medical literature and entry of adverse reaction reports into EudraVigilance

September 23, 2015

Last July EMA started a pilot phase to provide MAH’s a new service of medical literature searches (mandatory task for authorized products, according to pharmacovigilance legislation).

Asphalion’s article published this summer in BioScience Journal

September 22, 2015

“Biosimilars – What are the critical regulatory milestones during development and registration?”

Asphalion participates at European pharmaceutical regulatory environment seminar from EUCRAF

September 16, 2015

EUCRAF provides the opportunity of a specialized education in the area of biopharmaceutical-related regulatory affairs

CESP version 2.0 which will be released on the 1st October 2015

September 15, 2015

This new version incorporates new characteristics that answer directly to industry.

Upcoming training: “Pharmacovigilance, back to basics Masterclass”

September 14, 2015

The complete course presents the regulatory environment for the pharmaceutical industry along with numerous directives, regulations and guidelines.

What’s New in eSubmission?

July 24, 2015

The eCTD EU Module 1 v3.0 has been released for public consultation.

FDA: Increase of eCTD submissions of DMF

July 3, 2015

FDA presented the number of eCTD applications for Drug Master Files

Our team attended the eRA 2015 eRegulatory Affairs Conference (01-02 July 2015, Munich, DE)

June 29, 2015

Next Generation of Regulatory Information Management was the motto of eRA 2015.

Compliance with Pharmacovigilance legislation

June 26, 2015

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

AsphaNews – Special Edition FDA

June 26, 2015

Read about the latest news regarding the FDA

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

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.

AsphaNews June 2015

June 9, 2015

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

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.