DSRU looks forward to ISPE conference!
The DSRU team is off to Milan on 30th August for the 42nd Annual Meeting of the International Society for Pharmacoepidemiology (ISPE). We’re presenting some...
Shaping Vaccine Safety Evidence Across Europe
DSRU colleagues have contributed to a major VAC4EU study examining thrombosis with thrombocytopaenia syndrome (TTS) — a rare blood clotting condition — following the Oxford-AstraZeneca...
DSRU attends ISoP Mid-Year Meeting
Some of the DSRU’s pharmacovigilance experts attended the mid year meeting of the International Society of Pharmacovigilance (ISoP) in Hatfield, UK, this week. DSRU Director,...
DSRU/ PIPA Webinar: Additional Risk Minimisation Measures
The DSRU physicians, Dr Miranda Davies and Dr Sandeep Dhanda, were delighted to present a webinar to members of the Pharmaceutical Information & Pharmacovigilance Association...
Causality Assessment Tools: Scoping Review Published
The International Working Group (IWG) on New Developments in Pharmacovigilance has conducted a scoping review of Causality Assessment Tools (CATs) developed or updated between 2008...
DSRU Co-Hosts VAC4EU General Assembly in Southampton
The Drug Safety Research Unit (DSRU) is proud to co-host the 13th General Assembly Meeting of the Vaccine monitoring Collaboration for Europe (VAC4EU) at the...
Challenges in monitoring safety of GLP-1 agonists
Our recent editorial published in Drug Safety Journal describes the Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) that are currently available for use in the UK,...
Latest perspectives on PV data access and integration
The latest research from the DSRU’s International Working Group on New Developments in Pharmacovigilance has been published by Drug Safety. This work draws on the...
Post-authorisation safety study (PASS) completed for Glycopyrronium Bromide
The DSRU conducted a PASS in the UK on Glycopyrronium Bromide 1mg/5ml oral solution, a medicine which is prescribed to treat severe drooling in children...
Fruitful DSRU-MHRA work session
This week teams from DSRU and MHRA held a very successful work session to explore emerging challenges and opportunities in the UK pharmacovigilance landscape. We...
The DSRU is now a member of the SIGMA Consortium
We are delighted to announce that the DSRU is the newest member of the SIGMA Consortium. The consortium was established by ENCePP (the European Network...
Study report published: myo- and pericarditis following Pfizer Covid vaccination
The final report has been published for one of our collaborative studies into aspects of safety of the Pfizer-BioNTech Covid vaccine. The study aimed to...
DSRU team’s busy conference season
Members of the DSRU team have been busy over the past few months participating in a number of key events in drug and vaccine safety...
Efficient PASS based on bespoke data collection in secondary care
One of our key capabilities is to design and conduct PASS studies using bespoke data collection in primary, secondary or specialist care. While we use...
VAC4EU is 5 years old!
The DSRU team attended 5th anniversary celebrations of the Vaccine monitoring Collaboration for Europe (VAC4EU) in Brussels in November, joining with colleagues from across Europe...
Linda Härmark attends ISoP Annual Meeting in Cairo
Linda Härmark attended the Annual Meeting of the International Society of Pharmacovigilance (ISoP) in Cairo and gave a presentation on "What matters? Different perspectives and...
DSRU attends World Vaccine Congress Europe
We attended the World Vaccine Congress in Amsterdam in October, as part of a large delegation from Vaccine Monitoring Collaboration for Europe (VAC4EU). The DSRU’s...
DSRU attends World Drug Safety Congress Europe
The DSRU team had a very busy few days at the World Drug Safety Congress (WDSC) Europe in Amsterdam recently. We received a lot of...
The safety of paracetamol during pregnancy
The DSRU confirms that current evidence does not support a causal link between paracetamol use in pregnancy and autism. A large and rigorous Swedish study...
ISPE 2025: Spotlights on Real-World Evidence
The DSRU team attended the 41st International Society for Pharmacoepidemiology (ISPE) Annual Conference in Washington DC, where researchers, regulators, and industry leaders explored the evolving...
Looking forward to the ISPE Annual Meeting in Washington DC!
The DSRU team will be attending the 41st Annual Meeting of the International Society for Pharmacoepidemiology (ISPE) in Washington on 23rd-26th August. We will present...
DSRU joins Life Sciences Institute launch event at University of Portsmouth
A team from DSRU was pleased to participate in the launch of the Institute of Life Sciences and Healthcare (ILSH) at the University of Portsmouth...
Risk of Guillain-Barré syndrome after COVID-19 disease or vaccine
A large-scale international study involving researchers from the DSRU has highlighted the relationship between SARS-CoV-2 infection, certain COVID-19 vaccines, and Guillain-Barré syndrome (GBS). The research,...
Major real world safety study on Covid vaccine published
The DSRU has recently published the findings of its major post-authorisation safety study (PASS) on the AstraZeneca Covid vaccine in BMJ Open. This large scale...
Linda Härmark starts as new DSRU Director
Dr Linda Härmark has taken over the role of Director from Professor Saad Shakir, who has stepped down after 26 years at the DSRU. The...
VAC4EU Consortium’s General Assembly Meeting
Members of the DSRU’s Epidemiology team attended VAC4EU’s General Assembly Meeting in Valencia recently, accompanied by Linda Härmark, our new Director. The first day focused...
Linda Härmark announced as new Director of the DSRU
We are delighted to announce that Linda Härmark will be our new Director from 22 April 2025. Dr Härmark succeeds Professor Saad Shakir who is...
DSRU paper on lecanemab pharmacovigilance perspective
Our paper on lecanemab, a new anti-amyloid drug to treat Alzheimer’s Disease, emphasises the need for robust pharmacovigilance monitoring in order to determine its safety...
CPRD studies: How we use UK electronic health record (EHR) data
Conducting real-world post-authorisation studies on data from the Clinical Practice Research Datalink (CPRD) is one of the DSRU’s core activities. Recognition of the importance of...
DSRU delivers Real World Evidence training to FPM physicians
The DSRU team delivered a very successful one day hybrid training event on “Understanding and Interpreting Studies Using Real-World Data”, at the Faculty of Pharmaceutical...
12th Signal Detection conference: DSRU’s flagship event!
Our eagerly anticipated conference on Signal Detection and Signal Management will take place in London on 15-17th October. Don’t miss this opportunity to hear from...
14 August 2024
Looking forward to ICPE in Berlin!
The DSRU team will be attending the 40th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE) in Berlin on 24-28th August. The wide variety...
Professor Saad Shakir, Director of the Drug Safety Research Unit, to step down next year
Professor Saad Shakir, Director of the Drug Safety Research Unit (DSRU) based in Southampton, has today announced his intention to step down as Director with...
Our new course on Developing Gravitas in Pharmacovigilance
We are looking forward to our new masterclass on Developing Gravitas in Pharmacovigilance on 30th July. Gravitas is a crucial skill for business success, enabling leaders...
5 July 2024
Saad Shakir celebrates 25 years as DSRU Director
In this month’s PharmaTimes, Saad Shakir gives an interview in which he reflects on his 25 years at the Drug Safety Research Unit. He focuses...
19 June 2024
Discussing Evidence Supporting Regulatory Decisions at DIA Global!
At the DIA 2024 Global Annual Meeting in San Diego, Saad Shakir (DSRU Director), chaired a very successful session on “Evidence Generation to Support Regulatory...
3 June 2024
New self-development courses
We are delighted to announce an exciting development in DSRU Education & Training with the addition of a panel courses on self-development, management and leadership....
Meet the new Head of Education and Training at the DSRU
For more than 20 years, Dr Alison Evans has been conducting complex and vigorous studies into the safety of vaccines and drugs used in healthcare...
16 May 2024
DSRU urges uptake of vaccination amid steep rise in UK whooping cough cases
The UK Health Security Agency (UKHSA) has published data showing a continued increase in monthly cases of whooping cough in the UK. The UKHSA reminded...
Post-authorisation study on AstraZeneca Covid vaccine completed!
The COVID-19 vaccines were developed and tested rapidly, meaning that it was especially important to monitor their safety and effectiveness in the post-authorisation setting. The...
DSRU Systematic Reviews for Safety: latest publication
The DSRU conducts systematic literature reviews to support evidence-based decisions in drug safety. We recently published a systematic review on the safety of a non-steroidal...
International Working Group publishes first paper
The International Working Group (IWG) on New Developments in Pharmacovigilance has published its first paper. The paper details the IWG’s work in two areas in...
DSRU joins experts in recommending MMR vaccination
The UK Health Security Agency (UKHSA) has urged parents to ensure their children are fully vaccinated with the Measles, Mumps, Rubella (MMR) vaccine, in order...
European Network Studies Q&A
We asked Dr Miranda Davies, the DSRU’s Chief Medical Officer, to explain the key characteristics of European Network Studies: Q. What are the DSRU’s European...
International Working Group makes progress with causality and data sources
The International Working Group (IWG) on New Developments in Pharmacovigilance has been working hard throughout 2023. The IWG brings together around 70 experts from across...
What we do and reasons to approach the DSRU for your next observational study
The DSRU is a service provider and independent research organisation that conducts observational studies for both large and small pharma companies. These companies appreciate that...
Looking forward to ICPE in Halifax!
The DSRU team will be attending the 39th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE) in Halifax, Canada on 23-27th August. The wide...
Pan-European study of Covid vaccine safety published
The DSRU conducted the UK arm of this study which focused on the safety of all Covid-19 vaccines and was led by Lareb, the Netherlands...
DSRU attends DIA Europe conference
The DSRU team was delighted to attend the DIA Europe conference in Basel in March 2023 and to promote our capabilities as the UK’s leading...
How we’re leading UK pharmacovigilance
Here at the Drug Safety Research Unit, we are proud to be the UK's leading pharmacovigilance and pharmacoepidemiology unit. We have conducted hundreds of post-authorisation...
International group redoubles efforts to improve detection of drug side effects
The International Working Group (IWG) on New Developments in Pharmacovigilance has resumed its work in earnest, following an extended break due to the pandemic. Members...
30 September 2022
Just published: our paper on cases of thrombosis with concurrent thrombocytopenia following AstraZeneca Covid-19 vaccine.
In March 2021, rare signals of unusual clotting with concurrent low platelets began to emerge in people who had received at least one dose of...
Good to be back at ICPE!
The DSRU had a great conference at ICPE (International Conference on Pharmacoepidemiology & Therapeutic Risk Management) in Copenhagen last week. The in-person annual conference of...
20 May 2022
Our biennial Signal Detection conference is back!
After an extended break due to the pandemic, we are delighted that our iconic 11th Biennial Conference on Signal Detection and Signal Management in Pharmacovigilance...
18 May 2022
Risk minimisation at the DSRU
“The right medicine, at the right dose, at the right time, to the right patient” (GVP, Module XVI) Risk minimisation measures are actions taken to...
9 May 2022
DSRU hosts ISoP Mid-Year Symposium
Beyond Spontaneous Reporting: integrating data from multiple sources to ensure medicines safety The Drug Safety Research Unit (DSRU) hosts an important international meeting for the...
22 March 2022
Institute of Pharmacovigilance Sciences launched to improve global drug safety research methods
The Drug Safety Research Unit has today launched a new global Institute of Pharmacovigilance Sciences. A team of DSRU physicians, epidemiologists and biomedical scientists will...
17 March 2022
DSRU launches Institute of Pharmacovigilance Sciences with free webinar
The DSRU Institute of Pharmacovigilance Sciences has been established to build on the DSRU’s methodological research in pharmacovigilance and pharmacoepidemiology. The launch of the Institute...
8 March 2022
DSRU expands research team and 80% are women, nearly double the UK average in science roles
Ahead of International Women’s Day on Tuesday 8 March, the UK’s independent Drug Safety Research Unit (DSRU) has announced it’s doubled the size of its...
3 March 2022
Myocarditis and pericarditis in immunocompromised patients following COVID-19 mRNA vaccination
Summary: Systematic review of spontaneous reports of myocarditis and pericarditis in transplant recipients and immunocompromised patients following COVID-19 mRNA vaccination Two years after the start...
3 December 2021
The DSRU and the Future of UK Pharmacoepidemiology & Pharmacovigilance
The DSRU has expanded enormously in the last few years. As the UK’s premier unit for pharmacoepidemiology and pharmacovigilance, we have a full understanding of the...
17 September 2021
Pericarditis and myocarditis following mRNA vaccination: our review
The UK’s independent Drug Safety Research Unit (DSRU) has concluded that heart inflammation after mRNA COVID-19 vaccines is very rare and mild in the vast...
25 August 2021
Podcast: how we have been monitoring the safety of Covid vaccines
Listen to Saad Shakir on the MedTalk Podcast: Understanding Covid-19 vaccines with the DSRU. The DSRU is monitoring the safety of most of the UK’s...
2 August 2021
Vaccination provides weaker COVID-19 protection for immunocompromised patients
The DSRU Global Pharmacovigilance Observatory recently completed a systematic review of multiple studies comparing the immune response to COVID-19 vaccines in immunocompromised patients with that...
16 July 2021
DSRU Observational Studies on the COVID19 vaccines
Recruitment of participants is almost complete for our post-authorisation study to monitor the safety of the AstraZeneca COVID-19 vaccine. The study uses active surveillance methodology,...
6 April 2021
Pharmacovigilance Evidence Review: Rare blood clots with AstraZeneca COVID-19 vaccine in women under 55
Rare blood clots with AstraZeneca COVID-19 vaccine in women under 55 The DSRU has evaluated all publicly available data on blood clotting incidents after immunisation...
12 March 2021
Pharmacovigilance Evidence Review: Thrombosis following vaccination with COVID-19 AstraZeneca Vaccine
Professor Saad Shakir and Samantha Lane 12 March 2021 We agree with MHRA and EMA that people should continue to be vaccinated with the Oxford/AstraZeneca...
23 November 2020
Investigating Serious Adverse Events in COVID-19 Vaccine Trials
Despite the urgent need for a COVID-19 vaccine, it is of critical importance that the process of safety evaluation is not compromised in any way....
13 November 2020
Drugs repurposed for COVID-19 still need rigorous testing
Existing drugs repurposed to treat COVID-19 still need rigorous testing for safety and effectiveness and the DSRU is urging institutions across the globe to work...
6 November 2020
Rivaroxaban hospital PASS (ROSE study) papers published!
Two papers on the findings of our Rivaroxaban Observational Safety Evaluation (ROSE) study have just been published. ROSE is is a prime example of our...
22 October 2020
Paper published: Can post-marketing studies provide a safety net for COVID-19 vaccines in the UK?
Our new paper published in BMJ Evidence Based Medicine explains that, given the speed with which potential new COVID-19 vaccines are being developed, it is...
14 October 2020
DSRU comment on pausing of J&J COVID-19 vaccine trial
Director, Professor Saad Shakir, said: “Serious adverse events are expected in a clinical trial that includes 60,000 vaccinees. While the independent Data Safety Monitoring Board...
5 October 2020
Remdesivir for COVID-19 patients is ‘favourable’ says first systematic benefit-risk study
Remdesivir for COVID-19 patients is ‘favourable’ says first systematic benefit-risk study The first comprehensive evaluation of all possible benefits and risks of remdesivir The benefits...
18 September 2020
DSRU presents first ISoP journal club!
DSRU Senior Clinical Research Fellow, Dr Miranda Davies, and Director, Professor Saad Shakir, presented the first ever online journal club for the International Society of...
27 August 2020
Insufficient evidence for use of convalescent plasma in COVID-19 patients
Convalescent plasma (CP) treatment is one treatment option currently being investigated in COVID-19. Our review of evidence for a living systematic benefit-risk assessment of the...
11 August 2020
The One Million Study to monitor safety and effectiveness of COVID-19 vaccines
Our UK COVID-19 Vaccine Consortium has announced plans for the One Million Post-Authorisation Study to monitor the safety and effectiveness of the COVID-19 vaccine in...
29 June 2020
Lopinavir-Ritonavir in the Treatment of COVID-19: A Dynamic Systematic Benefit-Risk Assessment
Our dynamic systematic benefit-risk analysis of antiviral drug combination lopinavir-ritonavir for COVID-19 patients has just been published. Our research team found there was no clear...
22 June 2020
New consortium to monitor safety and effectiveness of COVID-19 vaccines
A new consortium to monitor the safety and effectiveness of COVID-19 vaccines has been formed by the Drug Safety Research Unit and MEMO Research, University...
29 May 2020
First systematic benefit-risk assessment of Remdesivir published
Remdesivir for COVID-19 patients is ‘favourable’ says first systematic benefit-risk study We have just published the first ever systematic benefit-risk analysis of antiviral drug remdesivir...
27 May 2020
Hospital PASS studies: conducting real-world observational studies in secondary care
Our article in the Spring edition of Pharmafile explains our unique SCEM method for conducting PASS studies in hospitals and specialist care in the context...
14 May 2020
The need for active surveillance of the safety and effectiveness of COVID-19 vaccines
(First published as a BMJ Rapid Response on 12th May 2020) A key component of efforts to control COVID-19 will be an effective vaccine. There...
30 April 2020
COVID-19: DSRU’s latest research and capabilities update
The DSRU team is heavily engaged in conducting studies related to the COVID-19 pandemic. Dozens of clinical trials are underway around the world, many on...
28 April 2020
Business as usual at the DSRU
The DSRU team is used to working remotely while maintaining high standards and completing studies on time. We have the connectivity to enable us to...
30 March 2020
Article: The need for evolution in pharmacovigilance
Pharmafocus published an interview with our Director, Saad Shakir, in its March issue, focusing on the need for pharmacovigilance to evolve in order to handle...
26 February 2020
Systematic Benefit-Risk Assessment published
Benefit-risk assessment is used to weigh up the benefits of a specific treatment with the risks of that treatment. The DSRU team has just published...
26 February 2020
Developing Gravitas: A masterclass in maximising your leadership potential
Improving your presence and impact in your organisation We are delighted to be working in collaboration with The Gravitas Programme to bring you a new...
7 February 2020
Milestone 20 years for DSRU pharmacovigilance training
DSRU Education & Training is celebrating two decades of training health and pharmaceutical professionals, many of whom have gone on to senior UK pharmacovigilance roles....
20 January 2020
New course for 2020 – Vigilance of Medical Devices
Addressing the uncertainty around implementation of the Medical Devices Regulation (MDR) The new European regulations on medical devices entered into force in 2017 and must...
3 January 2020
Improvements needed in recording brand and batch numbers for biological medicines to ensure patient safety
Health professionals need to improve how they record brand and batch numbers for biologic medicines to ensure patients stay safe, according to a new study...
5 November 2019
GPs urged to help improve patient safety
The DSRU had coverage in the BMJ last week following the issue of the press release below. The article is available to BMJ subscribers here....
25 October 2019
DSRU team at RCGP Annual Conference!
The DSRU team is delighted to be at the Annual Conference of the Royal College of General Practitioners (RCGP) in Liverpool. Our medics are on...
14 October 2019
Improving detection of adverse drug reactions
DSRU Director, Professor Saad Shakir, attended a three day meeting in Erice in Sicily on “Improving the Detection Analysis and Reporting Harms in Medicines”. The...
8 October 2019
Expanding the reach of Pharmacovigilance education with the Royal Pharmaceutical Society
The DSRU is delighted to be collaborating with the Royal Pharmaceutical Society to deliver two new training days. The courses are designed to introduce the...
24 September 2019
DSRU Consultancy: World class science at a not for profit price!
DSRU Consultancy has a small flexible team of epidemiologists, clinicians and pharmacists. Watch this short video to find out how DSRU Consultancy provides advice in pharmacoepidemiology, pharmacovigilance, risk minimisation and...
13 September 2019
Success of Big Data for Pharmacovigilance Conference!
The DSRU’s Second Conference on Big Data for Pharmacovigilance has been a great success. Delegates from regulatory bodies, the pharmaceutical industry and academia have heard...
27 August 2019
The DSRU is at ICPE in Philadelphia!
The DSRU team is attending the International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE) in Philadelphia. Come and meet our team at booth 204,...
2 August 2019
Big Data for Pharmacovigilance: looking forward to our 2nd conference!
Our second conference on Big Data for Pharmacovigilance takes place in September in London. We have an impressive line-up of speakers who will examine the...
26 July 2019
The importance of recording brand and batch numbers of prescribed biologic medicines
In 2017-18, the NHS saved over £200 million by using more biosimilar medicines1. In 2018, NHS England announced plans to increase the uptake of biosimilars...
23 July 2019
Congratulations to our 2019 Graduates!
Congratulations to our students who graduated from Masters in Pharmacovigilance earlier this month. Students graduating either completed their Postgraduate Certificate, Diploma or Masters in Pharmacovigilance,...
8 July 2019
IWG on Signal Detection & Management holds launch call
The launch teleconference for the International Working Group (IWG) on Signal Detection and Management in Pharmacovigilance took place last week. The key points raised included:...