Dominique Monferrer, Asphalion’s Medical Devices Expert, was invited to give a talk on Regulatory Aspects for Medical Devices to participants of the 3rd edition of Craash Barcelona program.
El próximo 14 de julio, Vicente Tur llevará a cabo el curso online “Gestión óptima de expedientes electrónicos con varias dosis o formas farmacéuticas” organizado por AEFI.
Rainer Rothe, Scientific and Regulatory Affairs Officer at Asphalion, attended the online session “Improving Human Health Through Artificial Intelligence” organised by CataloniaBio & HealthTech.
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El próximo 22 de junio, Marcos Fernández, Regulatory Affairs Associate Director de Asphalion, llevará a cabo el curso online “IDMP & RIMs y el Impacto en Regulatory Affairs” organizado por AEFI.
Asphalion would like to thank you to the 700+ participants who have joined us and would like to invite all of you to our YouTube channel, so you can access to the webinars whenever you want.
The AEMPS announced last week that in order to allow the normal activity of MAHs and to be able to supervise it adequately, the GCP and GMP inspection area will carry out remote pharmacovigilance inspections whenever possible.
The European Medicines Agency (EMA) decided to extend the Medical Literature Monitoring (MLM) service to cover substances used in products of interest in the COVID-19 context.
Updated version of the document “EMA post-authorisation procedural advice for users of the centralised procedure”
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.
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.