Free Webinar!

April 18, 2016

The implementation and use of the electronic Aplication Form (eAF) and the RAEFAR electronic platform – 25th April at 10:00h GMT

Thanks for visiting us!

April 14, 2016

Our team attended the 28th Annual DIA Euromeeting on 6-8 April. After three days of presentations and meetings with clients, the results have been more than satisfactory.

Asphalion will be participating at Informa’s Regulatory Information Management event

April 13, 2016

Asphalion is delighted to offer an exclusive 25% discount to its clients, click here to get it!

Happy World Health Day!

April 7, 2016

Asphalion contributes in the development of a new therapy to treat Diabetes in a project called ELASTISLET

Meet us at DIA!

March 17, 2016

ASPHALION will be present at booth K11 of DIA’s 28th Annual EuroMeeting in Hamburg next April.

Health Canada approves Asphalion for electronic submission preparation and submission by Gateway

March 15, 2016

Asphalion is happy to announce that it has been certified by Health Canada to perform electronic submission by the Gateway.

New version of QRD templates available

February 18, 2016

EMA has just published a new version of QRD templates for product information (version 10 for CP and version 4 for MRP/DCP)

Asphalion organizes the iHIVARNA Project’s 5th General Assembly Meeting

February 17, 2016

The first results with the first vaccinated patients are quite optimistic and the discussion on the phase II clinical trial was productive, setting the foundations for this second part of the project.

Second photo contest of Asphalion’s employees

February 16, 2016

We hope you enjoy them as much as we do!

Working in Centralised Procedures?

February 16, 2016

EMA is requesting Marketing Authorisation Holders and Drug Substance manufacturers (ASMF Holders) to use the full life cycle possibilities of eCTD.

EudraCT the new version 10.2.1.0 is now fully operational

February 2, 2016

EMA is now proposing a tight timeline of 6 months in which clinical trial results have to be entered into the system.

OPEN SEMINAR 2016: FDA Road to Success

January 7, 2016

Your seminar to become an expert in FDA Regulatory Affairs and eSubmission! Save the date! 9-10th March’16, Munich (Germany)

Latest news from eAF

December 22, 2015

The use of the electronic Application Form (eAF) is going to be mandatory.

PRIME Scheme

December 22, 2015

As part of the European Medicines Agency strategy to reinforce regulatory support and improve timely access to medicines, a new scheme will be launched in Q1 2016 to further support development of new medicines addressing major public health needs.

Changes with the report to the art 57 database

December 21, 2015

The EMA management board has released a communication that from 1 February 2016

Asphalion is looking for partners like you!

December 17, 2015

If you have a project that falls under the eligibility criteria for Horizon 2020 Programme, Asphalion is available to provide you with our regulatory expertise.

Asphalion contributes in recovery Nepal after the earthquake of April 15

December 16, 2015

We are very pleased to have participated in this charity project where the main objective has been to help recover Nepal after the earthquake in April 2015.

Latest news from the ISO IDMP S(ubstance)&P(roduct) meeting at EMA

December 4, 2015

The phased wise implementation of ISO IDMP will probably mean first submission of data end 2017 or 2018.
However, this is depending on the finalisation of the ISO standards

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.