Vigilance news

WEBINAR RECORDING | Regulatory tips for Medical Device and IVD developers

Article 86 MDR requires manufacturers of Class IIa, Class IIb, and Class III devices to prepare a Periodic Safety Update Report (PSUR) for each device and, when relevant, for each category or group of devices. The MDCG 2022-21 guideline endorsed by the Medical Device Coordination Group (MDCG) provides ideas for manufacturers on how to prepare the PSUR for their Medical Devices.

EVENT | DIA EUROPE

  March 22-24 | Congress Center, Basel Meet Asphalion’s team at DIA Europe, 2023!! The event will

EMA UPDATE! DAY ZERO FOR MEDICAL LITERATURE REPORTS

The European Medicines Agency (EMA) has issued a new Q&A for marketing authorization holders (MAHs) to clarify timelines regarding identifying individual case safety reports from physical/hard copy local journals.

Cena Navidad AEFI 2022 ASPHALION

AEFI ‘Xmas dinner

Una representación de expertos de Asphalion acudió anoche a la tradicional cena de Navidad de la Sección

EVENT | ISoP 2022

Shall we meet at ISOP22?? The 21st Annual Meeting of the International Society of Pharmacovigilance has just

Ready for ISoP 2022

The 21st Annual Meeting of the International Society of Pharmacovigilance (ISoP 2022) starts next week in Verona

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