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”.

Halloween and la castanyada

La Castanyada & Halloween in Asphalion

October 31, 2019

Asphalion is celebrating both events on the same day. Do you celebrate these festivities in your company too? Trick or Treat?

training

Training session on regulatory approach of ICH Q12

October 30, 2019

Yesterday, Consol Bozzo Mulet and Daniel Langa García gave a training session on regulatory approach of “ICH Q12: Control de cambios. Consideraciones técnicas y regulatorias en el ciclo de vida de los productos farmacéuticos.”.

ESCGT

Asphalion in the 27th ESGCT Annual Congress

October 23, 2019

Today Christopher Mann, Joel Montane and Oriol Penon are attending the 27TH ESGCT Annual Congress in Barcelona.

clinical trials

EudraCT | Clinical trials conduted in the EU need to be registered with the database

October 22, 2019

In June 2019, the EC, the EMA and the HMA co-signed a letter reminding all sponsors of clinical trials conducted in the EU of their obligation to make summaries of results of concluded trials publicly available in the EudraCT.

dekra

DEKRA Certification GmbH | The first IVDR Notified Body

October 15, 2019

Two months after being designated as the third Notified Body (NB) under the Medical Devices Regulation (MDR), Dekra Certification GmbH was annouced last week by the European Commission (EC) as the first NB to be designated under the EU In Vitro Diagnostic Regulation (IVDR).

Stakeholders update meeting

Stakeholders Update Meeting

October 14, 2019

Last Friday, Stakeholders Update Meeting took place in Madrid and was a great success!

MDR

MDR | SSCP: a guide for manufacturers and notified bodies

October 10, 2019

With the entry into force of the new Medical Devices Regulation (2017/745/EU, “MDR”), many new requirements to be met by the manufacturers have been established.

January 2020 | EDQM will require eCTD submissions for all applications

October 8, 2019

As published in the Electronic submissions for CEP applications Revised Roadmap 2016-2020, from January 2020, EDQM will require eCTD submissions for all applications including requests for revisions and renewals (except for TSE only submissions and for submissions for substances for veterinary use only).