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Ben Kemp

EMA Q&A on combinations MD/IVD/medicinal products European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EMA Q&A on combinations MD/IVD/medicinal products

An update from EMA on guidance especially for companion diagnostics. Note that this EU guidance also impacts Northern Ireland as it continues to follow the EU IVD Regulation. The document can be found here.  
Ben Kemp
February 17, 2025
CI/PS coordinated assessment pilot officially launched European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CI/PS coordinated assessment pilot officially launched

Please note that the European Commission has launched a dedicated website for clinical investigations and performance studies coordinated assessment pilot: Medical Devices - Clinical investigations and performance studies - European Commission and with this also officially opened the call for expression of interest for the Clinical Investigations (MD) pilot: Pilot coordinated assessment for CI/PS - European Commission For medical devices:…
Ben Kemp
February 14, 2025
Coordinated assessment for clinical investigations: a call for expression of interest European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Coordinated assessment for clinical investigations: a call for expression of interest

The EU have opened their  Coordinated assessment for clinical investigations: a call for expression of interest webpage.
Ben Kemp
February 14, 2025
Notice of AGM and call for nominations for BIVDA Executive Board Membership NewsMembership News Archive

Notice of AGM and call for nominations for BIVDA Executive Board

The BIVDA AGM will be held on Wednesday 26 March 2025 and new members of the Executive Board are announced at this meeting. The BIVDA Executive Board comprises 12 elected members, who serve for a period of three years. Retiring individuals may be nominated for a further term. This year there will six places available for election, who can be…
Ben Kemp
February 12, 2025