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josephmorris77
Feb 3, 202320 min read
Manufacture of Investigational Medicinal Products – Frequently Asked Questions
GMP and GCP Inspectors work closely with MHRA Clinical Trials and regularly provide support to help answer a wide range of stakeholder...
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josephmorris77
Feb 3, 202320 min read
Manufacture of Investigational Medicinal Products – Frequently Asked Questions
GMP and GCP Inspectors work closely with MHRA Clinical Trials and regularly provide support to help answer a wide range of stakeholder...
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josephmorris77
Aug 23, 20223 min read
Innovation, Quality & Transparency – a Compliance Team 1 Perspective
Lab assistants doing research. People in white coats using microscope, test tubes flat vector illustration. Laboratory, chemistry,...
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josephmorris77
Aug 23, 20223 min read
Innovation, Quality & Transparency – a Compliance Team 1 Perspective
Lab assistants doing research. People in white coats using microscope, test tubes flat vector illustration. Laboratory, chemistry,...
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josephmorris77
May 10, 20222 min read
Compliance Monitor Process (Part 2)– CM role and application process
This is the second part a two-part blog series on the Compliance Monitor Process which is being piloted by the MHRA from April 2022. As...
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josephmorris77
May 10, 20222 min read
Compliance Monitor Process (Part 2)– CM role and application process
This is the second part a two-part blog series on the Compliance Monitor Process which is being piloted by the MHRA from April 2022. As...
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josephmorris77
Mar 11, 20222 min read
Compliance Monitor process (Part 1) – An introduction
This is the first part of a two-part blog series on the Compliance Monitor process which is being piloted by the MHRA from April 2022....
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josephmorris77
Mar 11, 20222 min read
Compliance Monitor process (Part 1) – An introduction
This is the first part of a two-part blog series on the Compliance Monitor process which is being piloted by the MHRA from April 2022....
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josephmorris77
Feb 10, 20222 min read
New year, new standards for investigational medicines
New GMP requirements from 31 January 2022 Monday 31 January 2022 saw the Clinical Trial regulation (CTR) come into force in the European...
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josephmorris77
Feb 10, 20222 min read
New year, new standards for investigational medicines
New GMP requirements from 31 January 2022 Monday 31 January 2022 saw the Clinical Trial regulation (CTR) come into force in the European...
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josephmorris77
Jan 10, 20221 min read
Pharmacovigilance Inspection Metrics April 2020 to March 2021
The MHRA GPvP Inspection Metrics report for the period April 2020 to March 2021 is now available. Read the full metrics report published...
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josephmorris77
Jan 10, 20221 min read
Pharmacovigilance Inspection Metrics April 2020 to March 2021
The MHRA GPvP Inspection Metrics report for the period April 2020 to March 2021 is now available. Read the full metrics report published...
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josephmorris77
Dec 10, 20212 min read
Global reflections on international inspection transformation: ICMRA remote inspections
In August 2020 the International Coalition of Medicines Regulatory Authorities (ICMRA) established a working group to look at the move to...
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josephmorris77
Dec 10, 20212 min read
Global reflections on international inspection transformation: ICMRA remote inspections
In August 2020 the International Coalition of Medicines Regulatory Authorities (ICMRA) established a working group to look at the move to...
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josephmorris77
Sep 30, 20211 min read
Supply Chain webinar: recording now available
On 13 August 2021, the Medicines & Healthcare products Regulatory Agency (MHRA) held a webinar to provide information and guidance around...
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josephmorris77
Sep 30, 20211 min read
Supply Chain webinar: recording now available
On 13 August 2021, the Medicines & Healthcare products Regulatory Agency (MHRA) held a webinar to provide information and guidance around...
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josephmorris77
Sep 27, 20212 min read
Updated data integrity requirements for GLP Monitoring Programme members
The MHRA published the GXP Data Integrity Guidance in March 2018 (see https://mhrainspectorate.blog.gov.uk/2018/03/09/mhras-gxp-data-inte...
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josephmorris77
Sep 27, 20212 min read
Updated data integrity requirements for GLP Monitoring Programme members
The MHRA published the GXP Data Integrity Guidance in March 2018 (see https://mhrainspectorate.blog.gov.uk/2018/03/09/mhras-gxp-data-inte...
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josephmorris77
Sep 1, 20212 min read
MHRA and US FDA tackle challenging data integrity
MHRA, US-FDA and Health Canada colleagues at the London 2020 GCP symposium The second Medicines and Healthcare products Regulatory Agency...
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josephmorris77
Sep 1, 20212 min read
MHRA and US FDA tackle challenging data integrity
MHRA, US-FDA and Health Canada colleagues at the London 2020 GCP symposium The second Medicines and Healthcare products Regulatory Agency...
1 view0 comments
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