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Regulators’ experience of clinical trials during the Covid-19 pandemic (Part 3) – looking forward
In parts one and two of this series, we looked at how we responded to the unprecedented challenges the COVID-19 pandemic and the lessons...
josephmorris77
Feb 18, 20223 min read
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Regulators’ experience of clinical trials during the Covid-19 pandemic (Part 3) – looking forward
In parts one and two of this series, we looked at how we responded to the unprecedented challenges the COVID-19 pandemic and the lessons...
josephmorris77
Feb 18, 20223 min read
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0 comments


Regulator’s experience of clinical trials during the Covid-19 pandemic (Part 2) – what we have learn
In part one of this series, we explored as an introduction how we initially responded to the Covid-19 pandemic to move faster in the...
josephmorris77
Feb 14, 20227 min read
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Regulator’s experience of clinical trials during the Covid-19 pandemic (Part 2) – what we have learn
In part one of this series, we explored as an introduction how we initially responded to the Covid-19 pandemic to move faster in the...
josephmorris77
Feb 14, 20227 min read
1 view
0 comments
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...
josephmorris77
Feb 10, 20222 min read
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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...
josephmorris77
Feb 10, 20222 min read
2 views
0 comments


Regulator’s experience of clinical trials during the Covid-19 pandemic (Part 1) – our initial respon
The Covid-19 pandemic has been a challenging time for all of us and in this three-part blog series, we reflect on what we have learnt and...
josephmorris77
Feb 8, 20222 min read
1 view
0 comments


Regulator’s experience of clinical trials during the Covid-19 pandemic (Part 1) – our initial respon
The Covid-19 pandemic has been a challenging time for all of us and in this three-part blog series, we reflect on what we have learnt and...
josephmorris77
Feb 8, 20222 min read
1 view
0 comments
Public Consultation on new Clinical Trials Legislation
The MHRA has launched an  8-week public consultation on proposals for legislative changes for clinical trials. Following the UK’s exit...
josephmorris77
Feb 1, 20221 min read
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Public Consultation on new Clinical Trials Legislation
The MHRA has launched an  8-week public consultation on proposals for legislative changes for clinical trials. Following the UK’s exit...
josephmorris77
Feb 1, 20221 min read
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0 comments


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...
josephmorris77
Jan 10, 20221 min read
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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...
josephmorris77
Jan 10, 20221 min read
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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...
josephmorris77
Dec 10, 20212 min read
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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...
josephmorris77
Dec 10, 20212 min read
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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...
josephmorris77
Sep 30, 20211 min read
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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...
josephmorris77
Sep 30, 20211 min read
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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...
josephmorris77
Sep 27, 20212 min read
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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...
josephmorris77
Sep 27, 20212 min read
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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...
josephmorris77
Sep 1, 20212 min read
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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...
josephmorris77
Sep 1, 20212 min read
1 view
0 comments
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