COVID-19 | AEMPS will carry out remote inspections of Good Practice in Pharmacovigilance

by Asphalion

4 years ago
Pharmacovigilance, inspections, good practice

Due to the current situation originated by COVID-19, the Spanish Agency for Medicines and Health Products (AEMPS) announced last week that in order to allow the normal activity of Marketing Authori...

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

by Asphalion

4 years ago
EMA, authorisation, guidance

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

by Asphalion

4 years ago
regulation, EU, medical devices, notified bodies

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 Eu...

Commission Implementing Decision C(2020) 2532

by Asphalion

4 years ago
European Commission, standards, MDR, IVDR

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 ...

WEBINAR | MDR postponed: an opportunity that cannot be missed

by Asphalion

4 years ago
medical devices, MDR, opportunity

Our last webinar is available on Asphalion’s YouTube Channel.

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

by Asphalion

4 years ago
e-meeting, stem cells, biodistribution

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

by Asphalion

4 years ago
cell therapy, gen theraphy, drugs development

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

AsphaTrainings Program | Webinars schedule for May

by Asphalion

4 years ago
covid-19, webinars, AsphaTrainings

Following with our AsphaTrainings Program, today we present the May schedule with all the webinars that we have to offer in May.

Medical Devices | Guidance documents on clinical investigation and evaluation

by Asphalion

4 years ago
MD Software, guidance documents, medical devices

This week brings some good news for the medical devices (MD) manufacturers and notified bodies, as 4 different guidance documents on topics related to clinical investigation and evaluation have bee...

NDMA | Ranitidine medicines

by Asphalion

4 years ago
Ranitidine, FDA, medicines, stomach acid

In September 2019, the European Commission (EC) requested EMA to start a review of ranitidine medicines after tests showed that some of these products contained the impurity N-nitrosodimethylamine (ND...

Asphalion is offering all its expertise in Regulatory Affairs

by Asphalion

4 years ago
research, expertise, covid-19, medical devices

Asphalion and its experts are committed to bring solutions and alternatives to society during this exceptional situation. That is why we are offering all our expertise in Regulatory Affairs by:

AsphaTrainings Program | At Asphalion we preparing a spring full of online trainings in Regulatory Affairs

by Asphalion

4 years ago
webinars, educational events, AsphaTrainings Program

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. As a response ...