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The DSRU International Working Group on New Developments in Pharmacovigilance

The DSRU’s International Working Group (IWG) has resumed its work, following an extended break due to the pandemic. Bringing together over 65 global experts in...

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Is a systematic review right for you?

As experts in drug safety research, we use a range of study methods to get the right information for our clients, so they can keep...

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Never in the history of the DSRU has its role been so important to society.

The DSRU, the leading pharmacoepidemiology and pharmacovigilance unit in the UK, continues to conduct studies examining the safety of a range of medicinal products including...

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Blog: DSRU Global Pharmacovigilance Observatory – An Introduction

Samantha Lane and Saad Shakir 03 February 2021 There are a number of broad similarities between national medicines regulators across the world, however there are...

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12 week dosing interval for the two COVID-19 vaccines in the UK – an analogy

Saad Shakir on Pharmacovigilance: Obviously hepatitis A is a different virus with a different vaccine platform. However, analogies are very useful in science. This is...

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Blog: Decision regarding dosing of COVID-19 vaccines

Saad Shakir on Pharmacovigilance: Decision regarding dosing of COVID-19 vaccines Since last week’s approval of the AstraZeneca/ Oxford University COVID-19 vaccine, there has been some...

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Blog: Reporting rate of serious allergic reactions with the Pfizer/BioNTech vaccine – to put things in perspective

Saad Shakir writes: A reporting rate from spontaneous reporting can be biased because of inaccuracies in the numerator and denominator.  But it is an acceptable...

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Blog: The new SARS-CoV-2 variant – comments on transmission, virulence and response to COVID-19 drugs and vaccines

Saad Shakir writes: Speed of transmission - it is public knowledge that it transmits much faster with significantly higher R value. Virulence - There are...

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Blog: Anaphylaxis following immunisation with Pfizer/BioNTech COVID-19 vaccine – comments on the pharmacovigilance and clinical aspects of the association

Saad Shakir writes:  Pfizer/BioNTech vaccine is an effective and safe vaccine.  No one with history of allergy or a concern about it should decline vaccination without...

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Blog: Anaphylactoid reactions with Pfizer/BioNTech COVID-19 vaccine: pharmacovigilance perspective and public information needs

Saad Shakir writes: From a pharmacovigilance perspective, the signal detection and evaluation process was straightforward. Anaphylactoid reactions are designated medical events. This means that they...

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Swift response by regulator to anaphylactoid response in two COVID-19 vaccinees

Saad Shakir writes: Anaphylaxis is an allergic response by the body to external substances such as food, medicines and vaccines. The manifestations of anaphylaxis include...

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It is essential to monitor the post-authorisation safety and efficacy of new COVID-19 vaccines

We welcome today’s approval of the Pfizer/ BioNTech COVID-19 vaccine by the UK’s medicines regulator, the MHRA. This is wonderful news and a triumph for...

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Vaccine manufacturers’ safety commitment emphasises importance of post-authorisation safety and effectiveness monitoring

Saad Shakir writes: The chief executives of nine manufacturers of COVID-19 vaccines have pledged to only seek government approval once enough data has been collected...

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Post-authorisation safety and effectiveness studies will complement the pre-marketing studies for vaccines for COVID-19.

Saad Shakir writes: Early results from clinical trials on vaccines for COVID-19 are encouraging.  The effects of vaccines on antibody production are positive after 28...

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How pharmacovigilance needs to adapt in order to handle the challenges of advanced therapies and the COVID-19 pandemic

Saad Shakir writes: Pharmacovigilance has expanded in the last 10 to 15 years, shifting from low-level regulatory compliance to a more proactive approach. This is...

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Cytokine Storm: A major killer in patients with severe COVID-19 infection.

Cytokines are a group of proteins that are secreted by cells in the immune system.  They act as chemical messengers to regulate other immune cells. ...

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Is the UK facing its own opioid crisis?

Our Principal Research Fellow, Vicki Osborne, writes: The opioid crisis in the US is well known and the subject of much debate and media coverage;...

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MEDS: The DSRU Centre for Methods, Evidence and Regulations in Drug Safety

Saad Shakir writes: A new centre has been established at the DSRU to focus and expand the Unit’s methodological research. The mission of the DSRU...

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DSRU Consultancy: World class science at a not-for-profit price

Saad Shakir writes: DSRU Consultancy provides consultancy and advice on matters related to Pharmacovigilance, Pharmacoepidemiology, Risk Management and Risk Minimisation. The DSRU consultants are a...

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Measuring the Impact of Pharmacovigilance

Saad Shakir writes: Huge efforts and resources have been allocated to Pharmacovigilance around the world, with enormous progress in the last two decades. Signal Detection,...

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What are the main objectives of PASS studies for Risk Management?

Saad Shakir writes: In this short blog and video, Saad Shakir outlines the main objectives for PASS studies and describes the characteristics of those who...

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Designing studies for risk management plans that are acceptable to European regulators

Saad Shakir addresses the challenges of proposing post-authorisation safety (PAS) studies for risk management that would be approved by regulators:Designing and proposing studies for risk...

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DSRU attends the RCGP Annual Conference in Harrogate

A DSRU team attended the Annual Conference of the Royal College of General Practitioners (RCGP) in Harrogate on 6th - 8th October 2016. The conference...

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Pharmacovigilance Science in the UK and Europe in the years to come

Saad Shakir 19th July 2016 The UK has been a major player in medicines regulations in the EU since the establishment of the CPMP in...

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A Network of Studies – Risk Management and Risk Minimisation Studies Conducted by a Network of European Countries

Saad Shakir writes: "The 2012 EU pharmacovigilance legislation made it necessary in some cases to conduct a Post Authorisation Safety Study (PASS) in several European...

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