EMA 20th Regulatory Affairs and Pharmacovigilance Conference

by Asphalion

The 20th Regulatory Affairs and Pharmacovigilance conference of Medicines for Europe keeps on providing useful insights of the path ahead.

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List of Notified Bodies under IVDR (EU) 2017/746 on In-Vitro Diagnostic Medical Devices

by AKRN Scientific Consulting

A Notified Body is an organization that assesses the conformity of certain products before being placed on the EU market. The conformity assessment is a process by which you demonstrate that the produ...

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Preparation is key: brief checklist how to bring IVD MD into compliance with EU IVDR

by AKRN Scientific Consulting

The transition time for In vitro diagnostic medical devices (IVDs) to comply with the EU IVD Regulation 2016/746 (IVDR) is arriving at its end: IVDR will be fully implemented from 26 May 2022. New IVD...

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MDCG: nueva MDCG 2021-25 Aplicación de los requisitos de MDR a los productos ‘legacy’ y a los productos ‘old’

by Tecno-med Ingenieros

No sin polémica, la MDCG ha establecido un grupo de trabajo ad hoc relativo a las disposiciones transitorias y elabora esta guía para el resto de grupos de trabajo que ahora hace publica. Vemos que ...

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Seeking out predictive biomarkers to FGFR inhibitors in molecularly-selected metastatic breast cancer

by Vall d’Hebron

Recently published in Clinical Cancer Research*, results from patient-derived xenografts (PDXs) and breast cancer patient samples support the prospective validation of this approach in luminal CDK...

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La investigación frente al cáncer de próstata permite mejorar su manejo en la población cordobesa

by Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)

IMIBIC y Hospital Reina Sofía inician una campaña de prevención, en la línea de Movember, para frenar los datos que señalan a este tumor como el más frecuente en hombres.

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Drafts of the Science Law and the Start-ups Law

by GENESIS Biomed

An Opinion Piece by Josep Lluís Falcó– Managing Partner and CEO at GENESIS Biomed.

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Interview Oscar Alegre – Partner at DWF-RCD in the Innovation and Entrepreneurship Area, specialising in the Science and Technology Sector

by GENESIS Biomed

Nowadays there are international standards that are easily recognisable and accepted by all, which makes it much easier to close transactions regardless of the origin of the investor, especially in th...

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Asphalion's Highlights: First Quarter 2022

by Asphalion

We organized three great Webinars about veterinary regulation, ISO IDMP and DADI; AsphaWellbeing has been reshaped!; we launched a Regulatory Submissions ATLAS with the main regional eSubmissions requ...

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Ysios Capital appoints Wen Wen Cheng as Head of Legal

by Ysios Capital

Ysios Capital, a European life sciences venture capital firm, today announced that it has appointed Wen Wen Cheng as Head of Legal.

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Ascendo se suma a SILO para crear la primera consultora de España en innovación y salud

by SILO

Entre ambas firmas han asesorado a más de 50 empresas farmacéuticas, 20 empresas de tecnología sanitaria, 100 biotecnológicas, varios grupos hospitalarios privados y fondos de capital riesgo. En e...

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