Updated version of the document “EMA post-authorisation procedural advice for users of the centralised procedure”

May 29, 2020

Last week, European Medicines Agency (EMA) updated the guidance document “European Medicines Agency post-authorisation procedural advice for users of the centralised procedure”.

New regulation to ease the renewal of the designation of NBs and prevent shortages of MDs in the EU

May 27, 2020

The European Commission (EC) has published a Commission Implementing Regulation to ease the renewal of the designation of notified bodies (NBs) and prevent shortages of medical devices (MDs) in the European Union (EU).

Commission Implementing Decision C(2020) 2532

May 25, 2020

The European Commission (EC) has published a Commission Implementing Decision requesting a review (standardisation) of a set of existing standards, as well as new standards to be drafted, for support of Regulations 2017/745 (MDR) and 2017/746 (IVDR).

Asphalion is proud to be sponsor of the Online Strategy Meeting on CMC & Regulatory Affairs!

May 25, 2020

Asphalion will participate in the Online Strategy Meeting on CMC & Regulatory Affairs. Our RIM and data management expert, Marcos Fernández will provide a presentation on IDMP and the impact in regulatory affairs.

WEBINAR | MDR postponed: an opportunity that cannot be missed

May 22, 2020

Dominique Monferrer, one of our medical devices expert, held this free webinar on the postponement of the MDR, with an analysis of its impact and potential opportunities for the sector.

Asphalion team | Sant Jordi’s day

May 22, 2020

This year Asphalion decided to celebrate Sant Jordi’s day in a different and fun way.

Asphalion participated in the nTRACK 30 MM follow up e-meeting

May 13, 2020

Last week , our colleagues Marta Rayo and Marta Morales participated in the nTRACK 30 MM follow up meeting to discuss the project progress with all the partners.

23rd ASGCT Annual Meeting

May 12, 2020

ASPHALION is participating in the 23rd ASGCT herapy Annual Meeting organized by American Society of Gene & Cell Therapy.

AsphaTrainings Program | Webinars schedule for May

May 5, 2020

Following with our AsphaTrainings Program, today we present the May schedule with all the webinars that we have to offer in May. We think it is essential to keep  our Regulatory Affairs community updated and trained during this time.

Team-NB recommendations to MD manufacturers and stakeholders

May 5, 2020

TheTeam-NB members’ recommended on medical device manufacturers and other stakeholders to pursue their original plans for this transitioning as much as possible under the given circumstances.

AsphaTrainings Program | Free webinars on ATMPs

April 29, 2020

Tomorrow, Christopher Mann, our Scientific and Regulatory Affairs Associate Director, will hold two free webinars both related to Advanced Therapy Medicinal Products (ATMPs).

Medical Devices | Guidance documents on clinical investigation and evaluation

April 28, 2020

This week brings some good news for the MD manufacturers and notified bodies, as 4 different guidance documents on topics related to clinical investigation and evaluation have been published by the MDCG.

EMA has released a detailed guidance on ICSRs in the context of COVID-19

April 28, 2020

On April 21, EMA has released a document providing recommendations to the processing and submission of ICSRs associated with medicinal products used for the treatment or prevention of COVID-19 infection.

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

April 24, 2020

Due to the current situation originated by COVID-19, the European Commission has decided to adopt the proposal to postpone the date of application of the Medical Device Regulation (MDR).

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

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!

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!