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.
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.
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.
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: firstname.lastname@example.org
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: email@example.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 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
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.
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.
Exceptional measures applicable to clinical trials in Spain to manage problems arising from the COVID-19 emergency
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.
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.