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
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 and its experts are committed to bring solutions and alternatives to society during this exceptional situation.
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
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.
The European medicines regulatory network has agreed to extend the deadline to complete step 1 (risk evaluation) to 1 October 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.
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.
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.
Asphalion can be your ideal partner to carry out regulatory affairs activities and guide the product development strategy.
This year, considering the exceptional situation, BIO-Europe Spring will be delivered as a full digital event and Asphalion will be there!
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.
Christopher Mann’s brief summary of the latest scientific data on the novel coronavirus SARS-CoV-2 and the CODIV-19 disease.
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.
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.
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.
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.
Asphalion promotes different programs dedicated to expand and introduce areas not specifically related to Regulatory Affairs: Asphaforum.
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.
Finally, EMA have released version 1 of the EU IDMP Implementation Guideline (EU IG v1).
On March 1st Asphalion will join the solidarity march for the Hospital Sant Joan de Déu: La Magic Line.
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.
At Asphalion we work together with our clients to generate ideas and implement solutions that contribute to improve people’s quality of life.
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 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. 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, especially with smaller and academic sponsors.
Asphalion is pleased to announce the opening of a new office located in London (UK).
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.
As from January 1st 2020, the Formatted Letter Template used in CP applications is no longer maintained by EMA.
2020 is very special for us as we will celebrate the 20th Anniversary of Asphalion. Thank you for being part of it!
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).
