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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 3, 20223 min read
Decommission of eSUSAR
The MHRA is retiring the eSUSAR website in favour for Individual Case Safety Reports (ICSR) Submissions - providing users a more robust,...
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josephmorris77
Aug 3, 20223 min read
Decommission of eSUSAR
The MHRA is retiring the eSUSAR website in favour for Individual Case Safety Reports (ICSR) Submissions - providing users a more robust,...
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josephmorris77
Feb 24, 20223 min read
MHRA Good Practice Symposia Week (7 to 11 March 2022)
From Monday 7 to Friday 11 March 2022, the MHRA will be hosting a week-long series of events as part of the Good Practice Symposia Week. ...
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josephmorris77
Feb 24, 20223 min read
MHRA Good Practice Symposia Week (7 to 11 March 2022)
From Monday 7 to Friday 11 March 2022, the MHRA will be hosting a week-long series of events as part of the Good Practice Symposia Week. ...
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josephmorris77
Feb 18, 20223 min read
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...
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josephmorris77
Feb 18, 20223 min read
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...
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josephmorris77
Feb 14, 20227 min read
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...
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josephmorris77
Feb 14, 20227 min read
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...
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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
Feb 8, 20222 min read
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...
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josephmorris77
Feb 8, 20222 min read
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...
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josephmorris77
Feb 1, 20221 min read
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...
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josephmorris77
Feb 1, 20221 min read
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...
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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 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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