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 our employees.

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.

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

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

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.

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

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

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

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.

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

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

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.

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.

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.

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.

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

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

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 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.

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”.

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

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.

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.

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.

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

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!

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

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.

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.

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.

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.