Respiradores | Requerimientos a nivel regulatorio para su desarrollo y producción

April 7, 2020

Si estás trabajando en el desarrollo y producción de respiradores, aquí tienes los requerimientos según las última actualizaciones a nivel regulatorio. No dudes en contactar con nosotros si necesitas ayuda: covid19@asphalion.com

WEBINAR | Clinical Evaluation of Medical Devices according to EU MDR 2017/745

April 6, 2020

Don’t miss our last video in case you are interested in “Clinical Evaluation of Medical Devices according to EU MDR 2017/745” presented by Marta Rayo Lunar.

Asphalion is offering all its expertise in Regulatory Affairs

April 6, 2020

Asphalion and its experts are committed to bring solutions and alternatives to society during this exceptional situation.

Communications from Authorities in COVID-19 crisis

April 3, 2020

Asphalion has been closely following such publications to gather all possible information, while especially focusing on the Spanish situation. Here is a summary of the most important ones, organised by source, chronological order and scope: Communications from Authorities in COVID-19 crisis

AsphaTrainings Program | At Asphalion we preparing a spring full of online trainings in Regulatory Affairs

March 30, 2020

Today we are very pleased to announce the launch  of the AsphaTrainings Program. We think it is essential to keep  our Regulatory Affairs community updated and trained during this time.

Nitrosamine Impurities

March 27, 2020

The European medicines regulatory network has agreed to extend the deadline to complete step 1 (risk evaluation) to 1 October 2020.

COVID-19 impact on MDR | European Commission working to postpone MDR for 1-year

March 26, 2020

Due to the outbreak of the pandemic of COVID-19, the Commission recently announced that they are working on a proposal to postpone the application date of the MDR for one year.

EMA has started to review the list of Chargeable Units

March 23, 2020

As every year, European Medicines Agency (EMA) has started to review the list of Chargeable Units of the different holders in order to calculate the Pharmacovigilance Fee.

Exceptional measures applicable to clinical trials in Spain to manage problems arising from the COVID-19 emergency

March 20, 2020

Due to the COVID-19 situation, the AEMPS designed exceptional measures applicable to clinical trials in Spain to manage problems arising from the COVID-19 emergency.

Are you looking for a H2020 regulatory partner?

March 19, 2020

Asphalion can be your ideal partner to carry out regulatory affairs activities and guide the product development strategy.

Asphalion will attend BIO-Europe Spring!

March 18, 2020

This year, considering the exceptional situation, BIO-Europe Spring will be delivered as a full digital event and Asphalion will be there!

Asphalion’s prevention measures against COVID-19

March 12, 2020

We have been strictly following the recommendations of the health authorities on prevention measures against COVID-19 for several weeks now and we are ready to face any unusual situation without compromising the excellence of our services.

WEBINAR | The latest scientific data on the novel coronavirus SARS-CoV-2 and the COVID-19 disease

March 11, 2020

Christopher Mann’s brief summary of the latest scientific data on the novel coronavirus SARS-CoV-2 and the CODIV-19 disease.

Medical Devices Training Session

March 11, 2020

Yesterday, Marta Rayo Lunar, Sonia López Sánchez and Cindy Mancía, participated in the training session “MEDICAL DEVICES: Regulation and Compliance Expectations” organized by TDV, in light of the date of application of the MDR on 26th of May 2020.

Asphalion will participate in the 40th AEFI Symposium

March 2, 2020

Aspahlion is delighted and proud to announce that its experts will actively participate in the 40th AEFI Symposium, the master conference of the Spanish Industrial Pharmacists Association, as speakers of several workshops and debate tables.

First Submission of Asphalion UK

February 25, 2020

The submission of the first dossier in the UK by Asphalion Ltd has been a big success, not only for the team involved but also for the whole company.

UK | MHRA GPvP Symposium, 11th February 2020  

February 25, 2020

Following on the exit of the UK from the EU on 31st Jan 2020, this year’s MHRA Good Pharmacovigilance Practice (GPvP) Symposium was well attended and eagerly awaited by the pharmacovigilance professionals within the industry.

Asphaforum | Asphalion is more than Regulatory Affairs

February 20, 2020

Asphalion promotes different programs dedicated to expand and introduce areas not specifically related to Regulatory Affairs: Asphaforum.

New H2020 Project | Asphalion participated in the MISTRAL kick-off meeting

February 18, 2020

Asphalion is the regulatory partner for a successfully funded Horizon 2020 project entitled “Microbiome-based stratification of individuals at risk of HIV-1 acquisition, chronic clinical complications, antimicrobial drug resistance, and unresponsiveness to therapeutic HIV-1 vaccination”, MISTRAL.

EU ISO IDMP Implementation Guideline – V1

February 13, 2020

Finally, EMA have released version 1 of the EU IDMP Implementation Guideline (EU IG v1).

Asphalion & Magic Line 2020

February 12, 2020

On March 1st Asphalion will join the solidarity march for the Hospital Sant Joan de Déu: La Magic Line.

Pharmacovigilance and Regulatory services in the UK

February 11, 2020

As of 1 February 2020, the United Kingdom (UK) is no longer an EU Member State and acts as a third country. This means that the UK no longer participates in EU institutions and their decision-making.

Today is the International Day of Women and Girls in Science

February 11, 2020

At Asphalion we work together with our clients to generate ideas and implement solutions that contribute to improve people’s quality of life.

AsphaNews 2020 | First Newsletter of the year

February 10, 2020

Welcome back! Check out the first newsletter of the year to keep up to date with the latest news and events on the regulatory affairs and pharma sector!

Asphalion starts a new collaboration with Maria Molist

February 5, 2020

Asphalion is very pleased to announce the start of the collaboration with Maria Molist for the provision of pharmacovigilance/regulatory services in the UK.

Asphalion is attending the SBR H2020 project kick-off meeting

February 5, 2020

Asphalion is attending the SBR H2020 project kick-off meeting. Within the SBR project,  Asphalion will provide continuous regulatory support to all partners during the whole duration of the project.

Clinical Trials Results: The Lancet study suggests that compliance still needs to improve

February 3, 2020

Clinical Trials Results: The Lancet study suggests that compliance still needs to improve, especially with smaller and academic sponsors.

Asphalion opens new office in the UK

January 31, 2020

Asphalion is pleased to announce the opening of a new office located in London (UK).

MDR corrigendum | Manufacturers of Class I MD may have 4 years more to meet the regulation’s standards

January 13, 2020

UPDATE: The corrigendum for the EU’s Medical Devices Regulation (MDR) granting manufacturers of Class I devices upclassified under MDR a four-year transitional period has been approved and published.

Formatted Letter Template | No longer maintained by EMA

January 9, 2020

As from January 1st 2020, the Formatted Letter Template used in CP applications is no longer maintained by EMA.

Asphalion team wishes you a Merry Christmas and a Happy New Year

December 19, 2019

2020 is very special for us as we will celebrate the 20th Anniversary of Asphalion. Thank you for being part of it!

May 2020 | Only a few months remain for DoA of the new MDR

December 4, 2019

May 2020 is round the corner and therefore, only a few months remain for date of application (DoA) of the new medical device regulation (MDR).