WEBINAR | Update in antiretroviral assays against COVID-19

April 21, 2020

Don’t miss our last webinar in case you are interested in to do an update in antiretroviral assays against COVID-19. This webinar was presented by Christopher Mann.

How Asphalion is dealing with coronavirus

April 20, 2020

Nuria Romero, Bernat Autonell, Ricard Sagués and Andrea González are talking about how Asphalion is dealing with coronavirus.

Asphanews | Spring Edition

April 17, 2020

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

Pharmacovigilance | MedDRA Version 23.0 will be available on Sunday, April 19

April 17, 2020

Keep in mind that this Sunday, April 19, the MSSO and the JMO will re-release the previously distributed version 23.0 of the terminology including the usual files, translations in English and Japanese and new COVID-19 related terms and revisions.

WEBINAR | Post-Marketing Surveillance

April 16, 2020

Don’t miss our last webinar in case you are interested in “Post-Marketing Surveillance” presented by Nuria Cabello, Senior Drug Safety Officer at Asphalion.

NDMA | Ranitidine medicines

April 15, 2020

According to the ongoing assessment, the rapporteurs of the ranitidine referral consider that the benefit-risk balance of medicinal products containing ranitidine cannot be concluded as being positive and proposed to suspend all marketing authorisations with conditions to lift the suspension.

Mascarillas | Requerimientos a nivel regulatorio para su desarrollo y producción

April 7, 2020

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

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.