Clinical Trials COVID-19

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.

h2020 regulatory partner

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.

bio europe spring

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!

corona

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.

coronavirus

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.

Training Session TDV

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.

aefi symosium

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.

asphalion uk

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.

MHRA GPVP

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.

Aspharorum

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.

H2020 Mistral Consortium

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.

iso idmp

EU ISO IDMP Implementation Guideline – V1

February 13, 2020

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

MAGIC LINE

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.

PV and Reg Services

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

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.

sbr

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

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.

NEW OFFICE IN THE UK

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

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!

medical devices

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).

ASPHANEWS

Newsletter | Last ASPHANEWS of the year 2019 🌠

December 3, 2019

Take a quick look at our latest newsletter and keep up to date with the latest news and events on the regulatory affairs and pharma sector. Subscribe to our newsletter and become an expert in Regulatory Affairs!

forum hr

Asphalion attended the second edition of the “Forum d’Empreses de l’ámbit farmacèutic – sanitari“

December 2, 2019

Last week Asphalion attended the second edition of the “Forum d’Empreses de l’ámbit farmacèutic – sanitari“, organised by the Facultat de Farmàcia I ciències de l’alimentació de la Universitat de Barcelona.

Associate director

Marcos Fernández, New Regulatory Affairs Associate Director at Asphalion

November 26, 2019

Communication from the Board of Directors: Marcos Fernández, New Regulatory Affairs Associate Director at Asphalion

la marato tv3

Asphalion Walks for La Marató de TV3!

November 19, 2019

Yesterday, Asphalion’s values (commitment flexibility passion and teamwork) were demonstrated in a 17 km hike organized and walked by members of the company who traveled with family & friends from our offices in Barcelona to Sant Cugat del Vallès.

n-track

n-TRACK Project Review Meeting

November 13, 2019

Last week, our colleagues Marta Rayo Lunar and Marta Morales attended the n-TRACK Project Review Meeting in Cambridge to discuss the project progress with all the partners.

mdr ivdr

Q&A document on the implementation of the MDR and IVDR

November 12, 2019

The EMA has recently revised the Q&A document that provides practical considerations concerning the implementation of the MDR and IVDR.

medtech

Graphene Connect on MedTech and Diagnostic Technologies

November 7, 2019

Yesterday, November 6, Dominique Monferrer and Eduardo Garrido participated in the event Graphene Connect on MedTech and Diagnostic Technologies associated with the first Graphene for Health Investment Forum.

brexit

Brexit | Very interesting and productive day!

November 4, 2019

Last week, Lidia Cánovas and Nuria Romero participated in the seminar “Els efectes del Brexit en el sector Farma”.