BIO-Europe® Digital 2020, the largest life science partnering event worldwide, will take place next week, October 26th-29th. This event will be held digitally and Asphalion will be there!

Asphalion has signed an agreement to be part of Barcelona Health Hub (BHH), the international digital health institution aiming to promote innovation in digital health and its transfer to the sector, linking start-ups, health organizations, companies and investors.

This online training course will take place on the 4th and 5th of November, 2020 and it will provide you with an insight into the required information on how to set up your product development and successfully get an FDA registration approval.

Updates that allow pharmaceutical companies from now on to define a common strategy for the Nitrosamines Risk Assessment process.

Take a quick look at our Asphanews and keep up to date with the latest news on the regulatory affairs and pharma sector. Subscribe to our newsletter and become an expert in Regulatory Affairs!

From 1 January 2021, the MHRA will be the UK’s standalone medicines and medical devices regulator. This month the UK’s medicines regulator has published two new guidance documents.

Francisco Rodríguez, Scientific & Regulatory Affairs Officer at Asphalion, has been awarded a grant from the Government of Catalonia to conduct his doctoral thesis on Regulatory Science within the Medical Devices team of the Company.

The European Commission has launched a Manifesto to maximise the accessibility of research results in the fight against COVID-19 and Asphalion has signed it to reinforce its commitment to bring solutions and alternatives to fight this pandemic situation.

From 19 October 2020, scientific advice applicants will be required to use the IRIS Platform for Regulatory and Scientific Information Management to manage the scientific advice processes with EMA. EMA will hold online training sessions to guide and support you in the transition to IRIS.

Asphalion is excited and proud to officially welcome Talyta Carteano Pires as a Regulatory Affairs Manager, expert in Medical Devices.

El próximo 17 de septiembre de 10h a 13h, 3M y Asphalion se unen en la I Sesión Formativa Online “Filtración Esterilizante y Aspectos Regulatorios” para contaros las estrategias y claves de éxito para vuestros procesos.

Asphalion will be participating in the Advanced Therapies Congress & Expo 2020.

Although the date of application of the MDR has been postponed, on 26 May 2021 the Regulation will become fully applicable, following the transition period.

We will be open in August and available to attend all your needs and requests as usual!

Do you need regulatory support during your drug development? It has never been so simple to get it!

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.

Don’t you know how IDMP can affect the way you store your data? Do you need more information? Schedule a meeting with us!

On the 3rd of August 2017, the Committee of the Eurasian Economic Union (EAEU) released the standards for EAEU electronic submissions.

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.

Next week, from 29 June to 3 July, Asphalion will participate in the DIA Europe 2020.

Asphalion is committed with digital transformation and in easing the digital connection with you. From now on, you can request a meeting with our team with just two clicks.

Take a quick look at our latest newsletter and keep up to date with the latest news on the regulatory affairs and pharma sector. Subscribe to our newsletter and become an expert in Regulatory Affairs!

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.

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.