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Regulatory Affairs Newsletter Archive

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IFCC Webinar: “Minimum quality specifications based on the state of art” 4 September, 2024

This webinar comprises of three following presentations of 20 min each followed by 20 min of panel discussion at the end. Chair: Dr. Raul Girardi Talk 1- "State of the art" - Dr. Jorge Morancho Zaragoza Talk 2- "Algorithm for obtaining consensual minimum quality specifications" - Dr. Angel Manuel Salas García Talk 3- "State of the Art Charts" - Dr. Enrique Prada de Medio…
Ben Kemp
August 28, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Register now for BSI Notified/Approved Body & The Role It Plays In Patient Safety – 17 September 2024

What will participants gain? A better understanding of the regulatory systems in both the EU and UK The role BSI as a Notified/Approved Body plays in ensuring patient safety How patients and medical professionals can play their part in supporting safe and effective devices on the market Who should attend? Anyone who wishes to learn more about BSI and its role…
Ben Kemp
August 28, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Updates (WC 26 Aug)

DCMS Sectors Economic Estimates Page summary: This series brings together all documents relating to DCMS Sectors Economic Estimates. Change made: Added latest monthly GVA publication. Time updated: 9:30am, 20 August 2024 UK innovation diffusion and adoption survey Page summary: The Department of Science Innovation and Technology (DSIT) is conducting a survey of UK businesses. Help us understand how we can…
Ben Kemp
August 28, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates (WC 26 Aug)

Get someone to deal with customs for you Page summary: Find out how you can hire a person or business to deal with customs for you. Change made: Guidance updated to make it clear you will still be responsible for due diligence for your customs declarations if you appoint someone to deal with customs for you. Time updated: 2:01pm, 21…
Ben Kemp
August 28, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DEFRA Updates (WC 26 Aug)

General licences and authorisations to import live animals or animal products Page summary: Licences and authorisations to import genetic material, research and diagnostic samples, trade samples and display items, and some live animals and animal products. Change made: Updated 2 licences:- General licence to import certain products for in vitro use with 10% or less animal by-product carrier or stabilizer…
Ben Kemp
August 28, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

UKHSA Updates (WC 26 Aug)

Shingles vaccination: guidance for healthcare practitioners Page summary: Information about the shingles vaccination programme aimed at healthcare practitioners. Change made: Clarifications made in the 2 sections about severely immunosuppressed individuals who received Zostavax prior to becoming immunosuppressed. Time updated: 9:30am, 23 August 2024 Smallpox vaccine PGD template Page summary: PGD template for administering smallpox vaccine in response to mpox (monkeypox).…
Ben Kemp
August 28, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates (WC 26 Aug)

Our governance Page summary: The main decision-making, executive and managerial bodies at the Medicines and Healthcare products Regulatory Agency (MHRA). Change made: Added registration information for next meeting to be held on Tuesday 17 September 2024 Time updated: 10:17am, 23 August 2024 AI Airlock: the regulatory sandbox for AIaMD Page summary: A proactive, collaborative, agile and the first of its…
Ben Kemp
August 28, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

APHA Updates (WC 26 Aug)

General licences and authorisations to import live animals or animal products Page summary: Licences and authorisations to import genetic material, research and diagnostic samples, trade samples and display items, and some live animals and animal products. Change made: Updated 2 licences:- General licence to import certain products for in vitro use with 10% or less animal by-product carrier or stabilizer…
Ben Kemp
August 28, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Weekly Update (WC 26 Aug)

Overseas business risk: Honduras Page summary: The overseas business risk report provides information on security and political risks UK businesses may face when operating in Honduras. Change made: The guidance has been reviewed and updated where necessary, Time updated: 1:32pm, 19 August 2024 Overseas business risk for Guatemala Page summary: The overseas business risk report provides information on security and…
Ben Kemp
August 27, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU Proposed Common Specifications update

Please see the proposed update and introduction of new Common Specifications for Class D devices under the EU IVD Regulation. Please let us know if you have any feedback on the proposals. Note that the consultation close 16th September, so BIVDA will require feedback by Close of Business 13th September. Remember that these will apply in Northern Ireland, and MHRA…
Ben Kemp
August 27, 2024
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