360º interview with our Medical Device Manager, Talyta Carteano

por Asphalion

I am 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 ...

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'IDMP: Where to start'. Asphalion talk at the Global Pharmaceutical Regulatory Affairs Summit 2021 (GPRAS)

por Asphalion

The Global Pharmaceutical Regulatory Affairs Summit 2021 (GPRAS) will take place virtually from the 20th to the 22nd of April and Asphalion will be there!

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Vaccines & therapeutic clinical trials to boost COVID-19 prevention and treatment

por Asphalion

​ The European Commission has launched a call, COVID19 – HERA Incubator (HORIZON-HLTH-2021-CORONA-01), that will mobilize all means and resources necessary to prevent, mitigate and respond to t...

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IVDR Awareness

por Asphalion

As of May 2022, IVDR will become fully applicable, displacing the old In vitro diagnostic directive (IVDD). Implementing IVDR will be much easier with a good action plan in place. Asphalion can aid yo...

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AstraZeneca vaccine for COVID-19: benefits and risks

por Asphalion

Over the past weeks, several news on thromboembolic events potentially related to AstraZeneca’s vaccine for COVID-19 have been largely spread and disseminated.

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#BHHSERIES- MEDICAL DEVICE WEBINAR 'Medical Device Regulation (#MDR) for medical software: Are you ready?'

por Asphalion

The upcoming application of the Medical Device Regulation (#MDR) on May 26th 2021 may signify your digital solution is subject of qualification as a Medical Device. Software as Medical Device (SaMD) m...

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Rare Disease Day 2021

por Asphalion

​On the occasion of Rare Disease Day, at Asphalion we would like to highlight our commitment to the development of new treatments for rare diseases. We actively contribute to bringing treatments to ...

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Register now for the Regulatory and Scientific pathways for global advanced therapies medicinal products development (ATMPs) course by LS Academy!

por Asphalion

Starting next week, on the 16th, and extending for 2 mores sessions on the 18th and 22nd of February, the online training course on Regulatory and Scientific Pathways for Global Advanced Therapies Med...

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World Cancer Day 2021

por Asphalion

Today is World Cancer Day, a day to raise awareness of cancer and to encourage its prevention, detection and treatment. At Asphalion we are committed to the fight against cancer. We have collaborated ...

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BREXIT | What’s new for Pharma and Medical Devices

por Asphalion

Providing guidance about Regulatory Affairs and Trade changes in the Pharma and Medical Devices industries

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EMA 20th Regulatory Affairs and Pharmacovigilance Conference

por 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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Curso online: 'Novedades relacionadas con medicamentos en el entorno regulatorio europeo'. 4 y 5 de febrero, 2021

por Asphalion

Nuestros expertos Vicente Tur, Regulatory Affairs Director y Ramón Hernández Moratinos, Senior Regulatory Information Specialist, junto a Ana Viñas, Técnico de la AEMPS serán ponentes en el curso...

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