Last week, European Medicines Agency (EMA) updated the guidance document “European Medicines Agency post-authorisation procedural advice for users of the centralised procedure”.
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).
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 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.
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.
This year Asphalion decided to celebrate Sant Jordi’s day in a different and fun way.
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.
ASPHALION is participating in the 23rd ASGCT herapy Annual Meeting organized by American Society of Gene & Cell Therapy.
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.
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.
Tomorrow, Christopher Mann, our Scientific and Regulatory Affairs Associate Director, will hold two free webinars both related to Advanced Therapy Medicinal Products (ATMPs).
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.
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.
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).
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.
Nuria Romero, Bernat Autonell, Ricard Sagués and Andrea González are talking about how Asphalion is dealing with coronavirus.
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!
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.
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.
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.
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
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!
