EMA Network strategy to 2025

January 25, 2021

The European Medicines Agencies Network Strategy to 2025 was been detailed just last week during the 20th Regulatory Affairs and Pharmacovigilance conference.

#AsphaWellbeing: Asphalion´s new well-being programme for employees

January 19, 2021

#AsphaWellbeing: Asphalion´s new well-being programme for our employees.

Brexit advice: Schedule a meeting with us!

January 18, 2021

Recently, we have received a lot of questions regarding Brexit and the changes it might imply for your business. Because of this, we are offering free consulting sessions with one of our Regulatory experts to discuss your projects and needs.

Sonia López- New Pharmacovigilance Director at Asphalion

January 15, 2021

Asphalion’s Board of Directors is pleased to announce the appointment of Sonia López as new Pharmacovigilance Director.

Marta Rayo Lunar- New Scientific and Regulatory Affairs Director at Asphalion

January 7, 2021

Asphalion’s Board of Directors is pleased to announce the appointment of Marta Rayo Lunar as new Scientific and Regulatory Affairs Director.

BREXIT | Latest updates in Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP

December 21, 2020

As Brexit is quickly coming closer, the CMDh has published an updated version of the Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP in December 2020.

javier febrero

Javier Febrero Alija – New Regulatory Information Manager

December 17, 2020

Asphalion is excited and proud to officially welcome Javier Febrero Alija to its team as Regulatory Information Manager, expert in Data Management and RIMS.

Christmas season greatings

Season’s Greetings

December 17, 2020

We wish you Happy ‘Xmas, Prosperous New Year and Health for you and your loved ones.

chris mann dircetor

Christopher Mann – New Scientific and Regulatory Affairs Director

December 15, 2020

Asphalion’s Board of Directors is pleased to announce the appointment of Christopher Mann as new Scientific and Regulatory Affairs Director.

MDSW White Paper

WHITE PAPER | The EU Regulatory Environment of Medical Devices Software Development

December 14, 2020

Asphalion’s Medical Devices Experts have developed a white paper which provides an overview of the special challenges that MDSW developers will face under the MDR.

Dominique Director - medical devices

Dominique Monferrer – New Medical Devices Director

December 10, 2020

Asphalion’s Board of Directors is pleased to announce the appointment of Dominique Monferrer as new Medical Devices Director.

bernat dircetor it

Bernat Autonell – New Information Technology Director

December 7, 2020

Asphalion’s Board of Directors is pleased to announce the appointment of Bernat Autonell as the new Information Technology Director.

BREXIT PIP

BREXIT | Procedures for UK PIPs in case of a no-deal Brexit

December 4, 2020

The UK has left the EU and the transition period after Brexit comes to an end this year and from 1 January 2021 new regulations will apply. These changes will also affect the EU PIP maintenance and procedures.

15000 Linkeidn

Asphalion celebrates 15,000 followers on LinkedIn!

December 3, 2020

In order to celebrate this social media milestone, we have prepared a special (and the last of 2020) newsletter where we give you many news on Regulatory Affairs, Medical Devices, Brexit, etc.

free meeting

Schedule a meeting with us!

December 2, 2020

Are you developing a drug and need help with regulatory affairs? Schedule a meeting with our regulatory experts and introduce us your project and needs.

HIV Day

Today is World AIDS Day – Thanks to everyone working to end AIDS!

December 1, 2020

oday is World AIDS Day and we would like to take this opportunity to increase the awareness on this disease and to thank everyone working tirelessly to end AIDS.

EUDAMED

Medical Devices | EUDAMED – Actors Registration Module

December 1, 2020

Today, the European Commission has made available the EUDAMED Actor registration module to Member States and economic operators.

WORKSHOP ODD

Workshop on support for orphan medicines development by EMA

November 30, 2020

Montse de Castellarnau, Scientific & Regulatory Affairs Officer at Asphalion, will be attending the “Workshop on support for orphan medicines development”.

Barcelona Innovation Day/ London 2020

Barcelona Innovation Day/ London 2020

November 25, 2020

Lidia Cánovas, General Manager of Regulatory Affairs at ASPHALION and Board Member of CataloniaBio & HealthTech, will be participating in the session “Clinical Development After COVID-19” at 4:20 pm (CET time).

Asphalion sustainable company

Asphalion receives medal for sustainability from EcoVadis

November 25, 2020

Asphalion is proud to announce that it has been awarded a medal for Corporate Social Responsibility from EcoVadis, the world’s most trusted provider of business sustainability ratings, intelligence, and collaborative performance improvement tools for global supply chains.

WEBINAR MEDICAL DEVICES

Webinar | “Introduction to regulatory aspects of IVD medical devices”

November 25, 2020

This morning Marta Rayo Lunar, Scientific and Regulatory Affairs Director at Asphalion, will give a talk on Clinical Evaluation/ Performance of IVD medical devices during the webinar “Introduction to regulatory aspects of IVD medical devices”.

Digital Health Panel Discussion

Digital Health Panel Discussion 2020 – “Overcoming top challenges in digital health”

November 20, 2020

From Asphalion, we would like to especially thank all the speakers for their contribution and all the attendees for their predisposition to active participation.

UK Spain COVID-19 Vaccines Roundtable

UK Spain COVID-19 Vaccines Roundtable

November 20, 2020

Aina Planelles, Senior Business Developer at Asphalion, has participated at the UK Spain COVID-19 Vaccines Roundtable organized by the British Embassy in Madrid and the Consulate General in Barcelona.

New online platform to request Scientific Advice

New online platform to request Scientific Advice (EMA)

November 19, 2020

The EMA has updated the procedure to request Scientific Advice. Since October 19th, the request for Scientific Advice, Protocol Assistance and Qualification Procedure to the EMA has to be performed though the IRIS Regulatory & Scientific Information Management Platform.

MedSafetyWeek

Why is it so important to encourage people to notify adverse drug reactions?

November 11, 2020

Last week, the MedSafetyWeek was held. Reporting side effects is not only useful for brand-new medicines, but also provides crucial information on the safety profile of older medicines that we think we might know well enough.

eSUBManager

eSUBManager – Nueva herramienta desarrollada por Extedo

November 10, 2020

Asphalion presenta eSUBManager, una herramienta desarrollada por Extedo que en conexión con el eCTDManager permite, entre otras funciones.

Asphanews, newsletter

AsphaNews, our newsletter | Stay tuned!

November 6, 2020

AsphaNews provides you with the latest news, tips, advices and fresh perspectives on Regulatory Affairs. Are you already subscribed? If not, you can subscribe today!

SAP implementation, a big step to a complete Asphalion’s Digital Transformation

SAP implementation, a big step to a complete Asphalion’s Digital Transformation

November 5, 2020

It is with great pleasure and enthusiasm that we would like to inform you about the implementation of SAP, our new ERP system.

New draft standardisation request for harmonised MDR and IVDR standards

New draft standardisation request for harmonised MDR and IVDR standards

November 4, 2020

The EU has published a new draft standardisation request, asking the CEN and the Cenelec to revise the existing harmonized standards and to draft new standards to cover specific areas of both MDs and IVDs under the new regulations.

Is your xEVMPD database ready?

Is your xEVMPD database ready?

October 30, 2020

One of the first steps executed by the EMA to prepare for the implementation of ISO IDMP will be the migration into the new PMS database.

Updates on the Ongoing guidance development within MDCG Subgroups

Updates on the Ongoing guidance development within MDCG Subgroups

October 29, 2020

Now that the year is about to come to an end, the EC has updated the information on the MDCG’s work in progress, indicating the planning for the endorsement of the guidance documents of the MDCG Subgroups.

Medical device software industry (3)

Medical Device Software Industry – Germany, pioneer in Healthcare App insured prescription

October 22, 2020

By adopting the Digital Healthcare Act (DVG) (October 5th, 2019), Germany became a pioneer in Healthcare App insured prescription, marking one of the greatest milestones for the Medical Device Software industry.