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News Archive
MHRA Blog - Compliance Monitor Process (Part 2)– CM role and application process
11th May 2022Compliance Monitor Process (Part 2)– CM role and application process - a new blog post from the MHRA.
EMA - CTIS newsflash #11 - 22 April 2022
4th May 2022EMA - CTIS newsflash #11 - 22 April 2022
EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2022
4th May 2022EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2022
EMA - Overview of comments on on ICH guideline Q9 (R1) on quality risk management
4th May 2022EMA have provided an overview of comments received between December 2021 and March 2022 on on ICH guideline Q9 (R1) on quality risk management.
MHRA - Compliance Monitor (CM) Overview and Application Process
4th May 2022From April 2022, the MHRA will be running a pilot scheme to monitor companies that fail to comply with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) and are referred to the Inspection Action Group (IAG) after an inspection that has resulted in the compliance escalation process being initiated.
EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 April 2022
19th April 2022Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 April 2022
FDA - Request for Comments.- Cybersecurity in Medical Devices
19th April 2022FDA Request for Comments - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
FDA/ICH - E8(R1) General Considerations for Clinical Studies
19th April 2022FDA/ICH - E8(R1) General Considerations for Clinical Studies.
EMA - Public Consultation on the Approach of Protection of Personal data
13th April 2022The European Medicines Agency has published for public consultation a draft guidance document on how to approach the protection of personal data and commercially confidential information in documents uploaded and published in the Clinical Trial Information System (CTIS).
ICH - Analytical Procedure Development Q14
7th April 2022ICH ANALYTICAL PROCEDURE DEVELOPMENT Q14 - Draft version
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