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News Archive
MHRA - Updated CAPA Guidance
28th September 2022MHRA have updated the CAPA guidance PDF on 27th September.
PIC/S - Publication of revised PIC/S Annex 1
28th September 2022Publication of revised PIC/S Annex 1 The revised Annex 1 to the PIC/S GMP Guide on the manufacture of sterile products has been published and will enter into force on 25 August 2023, except for point 8.123 which is postponed until 25 August 2024. The date of entry into operation is aligned with that of the revised EU Annex 1, which is identical to PIC/S Annex 1 (with some very minor editorial differences).
EDQM - Call for experts: join the Ph. Eur. network
14th September 2022EDQM - Call for experts: join the Ph. Eur. network
EMA - Event Summary
14th September 2022EMA - Event Summary on Workshop on the guidance on the protection of personal data and commercially confidential information (CCI) in documents submitted or uploaded via CTIS
EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 September 2022
14th September 2022EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 September 2022
EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August – 1 September 2022
14th September 2022EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August – 1 September 2022
FDA - Computer Software Assurance for Production and Quality System Software
14th September 2022Draft Guidance has been released on Computer Software Assurance for Production and Quality System Software.
MHRA - new conflicts of interest code of practice for independent advisors
14th September 2022MHRA - new conflicts of interest code of practice for independent advisors
MHRA - Guidance on Medical devices: software applications (apps)
14th September 2022MHRA - Guidance on Medical devices: software applications (apps). Added - 'Appendix 4 – Field Safety Warnings and End-of-Life notification'
MHRA - Summary of responses to consultation - new Code of Practice for the Expert Advisory Committees
14th September 2022MHRA - Summary of responses to consultation - new Code of Practice for the Expert Advisory Committees
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