SAP implementation, a big step to a complete Asphalion’s Digital Transformation

by Asphalion

It is with great pleasure and enthusiasm that we would like to inform you about the implementation of SA​P, our new Enterprise Resource Planning (ERP) system.

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Is your xEVMPD database ready?

by Asphalion

One of the first steps executed by the EMA to prepare for the implementation of ISO IDMP will be the migration into the new PMS database.

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Updates on the Ongoing guidance development within MDCG Subgroups

by Asphalion

Now that the year is about to come to an end, the European Commission has updated the information on the MDCG’s work in progress, indicating the planning for the endorsement of the guidance document...

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Medical Device Software Industry – Germany, pioneer in Healthcare App insured prescription

by Asphalion

By adopting the Digital Healthcare Act (DVG) (October 5th, 2019), Germany became a pioneer in Healthcare App insured prescription, marking one of the greatest milestones for the Medical Device Softwar...

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WEBINAR | Are you ready for the IVDR? Regulatory impact and milestones for CE marking

by Asphalion

Next month, Dominique Monferrer will hold a webinar aimed to help manufacturers of in vitro diagnostic medical devices to understand the impact of the new In Vitro Diagnostic Regulation (IVDR), the mo...

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BIO-Europe® Digital 2020

by Asphalion

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!

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Asphalion joins Barcelona Health Hub to boost technological and digital innovation in the healthcare sector

by Asphalion

Aspha​lion has signed an agreement to be part of Barcelona Healt​h Hub (BHH), the international digital health institution aiming to promote innovation in digital health and its transfer to the se...

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Register now for the Advanced FDA Regulatory Affairs online training course by LS Academy!

by Asphalion

The Advanced FDA Regulatory Affairs 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 y...

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Nitrosamines Risk Assessment – Deadlines & Updates

by Asphalion

In both 2018 and 2019 the presence of N-nitrosamines was found in sartans with a tetrazole ring but it was also detected in other API/medicinal products (e.g. in some batches of pioglitazone and ranit...

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Brexit | New guidance documents from MHRA

by Asphalion

From 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s standalone medicines and medical devices regulator.

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Asphalion signs the Manifesto for EU COVID-19 Research

by Asphalion

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 soluti...

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Transition to IRIS | Online training sessions to guide and support you in the process

by Asphalion

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. To...

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