MISTRAL | EU-funded project to decipher the role of microbiome on HIV pathogenesis and cure

June 11, 2021

The EU-funded MISTRAL project is exploring the gut microbiota in relation to HIV-1, seeking microbiome biomarkers to support development of interventions that mitigate infection and enhance response to vaccines and therapies.

HONORING PRIDE MONTH

June 9, 2021

Pride Month commemorates the uprising at the Stonewall Inn back in June 1969. This sparked a liberation movement, a call to action to foster a culture where everyone feels comfortable being their full and authentic selves.

WEBINAR | Quality Management Systems: MDR and IVDR impact

June 4, 2021

Regulations EU/20174/745 (Medical Device Regulation- MDR) and EU/2017/746 (In Vitro regulation- IVDR) bring requirements for Quality Management Systems.

FORUM INSTITUT COURSE | Marketing authorisation procedures and lifecycle management

June 3, 2021

ASPHALION experts Lidia Cánovas, Vicente Tur and Ramón Hernández Moratinos, together with other four excellent speakers will share their in-depth knowledge with you and will provide you with practical tips on the requirements for new and existing approvals in Europe.

MEDICAL DEVICE REGULATION (EU) 2017/745 (MDR) | KEY SOLUTIONS PROVIDED BY ASPHALION

May 28, 2021

ASPHALION experts will help you make sure your device complies with the new MDR requirements.

CENTRALISED PROCEDURE PROCESS

May 28, 2021

The centralised procedure (CP) is the European Union-wide procedure for the authorisation of medicines, where there is a single marketing- authorisation application to EMA, a single evaluation and a single authorisation.  Only certain medicines are eligible for the centralised procedure. 

MEDICAL DEVICE REGULATION (EU) 2017/745 (MDR) | KEY CHANGES DECALOGUE

May 27, 2021

The new Medical Devices Regulation (MDR) represents a long-awaited strengthening of the existing European regulatory system for medical devices. Our team of regulatory experts at Asphalion is ready to assist companies in meeting the challenges the application of MDR will pose for the MedTech industry.

MEDICAL DEVICE REGULATION (EU) 2017/745 (MDR) | Date of application

May 26, 2021

The new Medical Devices Regulation (MDR) represent a long-awaited strengthening of the existing European regulatory system for medical devices.

U.K Responsible Person

May 25, 2021

From January 1st 2022, all devices sold in Great Britain and/or Northern Ireland are to be registered with the MHRA.

QMS Audit

May 21, 2021

Have you carried out your annual internal audit yet? If you haven’t, Asphalion can help you!

Advanced Therapies Congress 2021 starts tomorrow!

May 18, 2021

Advanced Therapies Congress & Expo 2021, the world’s largest commercially focused ATMP event, will be held online again this year. Our expert, Christopher Mann, Scientific & Regulatory Affairs Director at Asphalion, will be delivering a talk.

Webinar | The journey from software to Medical Device

May 18, 2021

Do you know if your software product acts as a Medical Device? Are you interested on what aspects are needed so your software product becomes regulatory compliant with the Software as a Medical Device regulation in the EU? Are you interested in learning how technology and best practices can boost the design, release, maintenance and CE certification of your product?

U.K Responsible Person

May 14, 2021

From September 1st 2021, Class IIb Non-implantable MDs, Class IIa MDs, List B IVDs, Self-test IVDs, as well as custom made devices according to device class should be registered with MHRA to be placed in the UK market.

Advanced Therapies Congress 2021. Asphalion´s expert talk

May 14, 2021

Advanced Therapies Congress & Expo 2021, the world’s largest commercially focused ATMP event, will be held online again this year. Our expert, Christopher Mann, Scientific & Regulatory Affairs Director at Asphalion, will be delivering a talk.

Webinar | Todo lo que necesitas saber sobre eSUBManager

May 13, 2021

Este Webinar consistirá en una explicación y demostración de la herramienta eSUBManager y de las posibilidades que ofrece para la gestión de registros.

Advanced Therapies Congress 2021

May 11, 2021

Advanced Therapies Congress & Expo 2021, the world’s largest commercially focused ATMP event, will be held online again this year.

Symposium AEFI 2021

May 11, 2021

Hoy finaliza la 40ª edición del Symposium de AEFI.

Symposium AEFI 2021

May 10, 2021

Hoy comienza la 40ª edición del Symposium de AEFI, que se celebrará de forma virtual los próximos 10 y 11 de mayo.

Symposium AEFI 2021

May 7, 2021

La 40ª edición del Symposium de AEFI se celebrará de forma virtual los próximos 10 y 11 de mayo y Asphalion estará presente.

Symposium AEFI 2021

May 6, 2021

La 40ª edición del Symposium de AEFI se celebrará de forma virtual los próximos 10 y 11 de mayo y Asphalion estará presente.

U.K Responsible Person

May 6, 2021

As of May 1st 2021, class III, class IIb implantable and active implantable devices, as well as In vitro diagnostics classified as ‘List A’ shall be registered with MHRA to still be placed in the UK market.

360º interview with our Medical Device Manager, Talyta Carteano

May 5, 2021

Talyta is a medical device professional with R&D and regulatory background and over 10 years’ experience in the field of Medical Devices, combining a technical background with a fulfilling career in the areas of devices design and development, regulatory affairs and quality management systems and leading people.

Symposium AEFI 2021

May 5, 2021

La 40ª edición del Symposium de AEFI se celebrará de forma virtual los próximos 10 y 11 de mayo y Asphalion estará presente.

FDA | GDUFA Self-identification campaign

May 4, 2021

The GDUFA Self-Identification campaign is here!

WHITE PAPER | Impact of MDR on Directive 2001/83/EC: What you need to know

May 4, 2021

The Medical Device Regulation 2017/745 (MDR)1 has been out and about for almost four years after its entry into force in May 2017.

U.K Responsible Person

May 3, 2021

Since January 1st, 2021, Medical Device manufacturers located outside the United Kingdom and without any local business offices shall appoint a United Kingdom Responsible Person (UKRP), on their behalf, as a pre-requisite for device registration and launch of the device in the United Kingdom.

Symposium AEFI 2021

May 3, 2021

La 40ª edición del Symposium de AEFI se celebrará de forma virtual los próximos 10 y 11 de mayo y Asphalion estará presente.

WEBINAR: vNeeS Veterinary Submissions

May 3, 2021

 Join our online conference on the 18th of May, 2021, 1:00 p.m. (CEST) to know more about the new regulations in vNeeS Veterinary Submissions.

Asphalion Team acknowledgement

April 30, 2021

Today, finishing the first four-month period of 2021, we would like to thank our team at Asphalion for their effort and the good results.

Update of eCTD Module 1 Specification to version 3.0.4

April 28, 2021

Update of eCTD Module 1 Specification to version 3.0.4

🌹 Sant Jordi | Internal contest

April 23, 2021

As previously announced, we are happy to share a sample of the works presented by our teams to our “creativity” contest on the occasion of Sant Jordi!!

Feliç Sant Jordi!

April 23, 2021

The tradition goes on! Following last year´s success, at Asphalion we have organized a “creativity” contest on the occasion of Sant Jordi.