{"id":4370,"date":"2022-12-16T09:48:42","date_gmt":"2022-12-16T09:48:42","guid":{"rendered":"https:\/\/www.dsru.org\/?page_id=4370"},"modified":"2023-03-23T11:24:30","modified_gmt":"2023-03-23T11:24:30","slug":"blog","status":"publish","type":"page","link":"https:\/\/www.dsru.org\/information-news\/blog\/","title":{"rendered":"Blogs"},"content":{"rendered":"\n
\n
\n\n<\/div>\n\n
\n
\n\t\t\t\t
\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"Saad\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

AI and Multiple Data Sources in Pharmacovigilance\u00a0<\/h3>\n\t\t\t\t\t

Saad Shakir writes: I attended the DIA Europe meeting in Basel on 18-20 March 2025.  The application of AI in all phases of the medicines...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

Licensing lecanemab by the MHRA in the UK: pharmacovigilance comments<\/h3>\n\t\t\t\t\t

Saad Shakir writes: Humanised monoclonal antibodies for dementia are very complex products with a narrow benefit risk balance at the time of launch. The MHRA...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

The approval of lecanemab for early Alzheimer\u2019s disease by the MHRA: The pharmacovigilance perspective<\/h3>\n\t\t\t\t\t

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted the approval of lecanemab for the treatment of Alzheimer\u2019s disease (AD) in patients with mild...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

Benefit\/Risk Balance or What?<\/h3>\n\t\t\t\t\t

What are the right words? There is certainly one inappropriate one which is benefit\/risk ratio, because there are no identical units, and it is not a...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

From the World of Pharmacovigilance: Strengthening of risk minimisation measures for topiramate demonstrates dynamic nature of risk minimisation activities<\/h3>\n\t\t\t\t\t

The MHRA has recently introduced restrictions on the use of topiramate, accompanied by enhanced risk minimisation activities. In this blog we explain the background to...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

Thoughts from Saad Shakir on adverse drug reactions, polypharmacy and reducing medicine-related harm<\/h3>\n\t\t\t\t\t

Is everyone like me? I sit in a cafe, an airport lounge or a train station and watch people. I wonder what medications this man...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

Unfavourable benefit-risk balance of codeine linctus: reclassification to Prescription Only Medicine<\/h3>\n\t\t\t\t\t

The MHRA has recently announced that codeine linctus has been reclassified from a pharmacy medicine to a prescription-only medicine due to the risk of dependence,...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

From the World of Pharmacovigilance: Strengthening of risk minimisation measures for isotretinoin<\/h3>\n\t\t\t\t\t

Treatment with isotretinoin for patients under 18 must be approved by two prescribers The UK medicines regulator, the MHRA, has recently announced a tightening of...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"Breast\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

A milestone in the history of medicine: Anastrazole<\/h3>\n\t\t\t\t\t

Anastrazole - a drug to be taken by cancer-free women to reduce the probability of developing breast cancer. This is a milestone in the pharmacological...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

Returning to the Horizon Europe programme \u2013 let’s collaborate again<\/h3>\n\t\t\t\t\t

Last month, we received the welcome news that the UK re-joined the flagship Horizon Europe research programme. Researchers across the scientific community, including everyone at...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

Blog: Roundup of DSRU research on Covid-19 vaccines and treatments<\/h3>\n\t\t\t\t\t

Since the beginning of the Covid-19 pandemic, we have conducted multiple studies to monitor the safety of Covid-19 vaccines. The DSRU is a small, nimble...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

The DSRU International Working Group on New Developments in Pharmacovigilance<\/h3>\n\t\t\t\t\t

The DSRU\u2019s International Working Group (IWG) has resumed its work, following an extended break due to the pandemic. Bringing together over 65 global experts in...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

Is a systematic review right for you?<\/h3>\n\t\t\t\t\t

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...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

Never in the history of the DSRU has its role been so important to society.<\/h3>\n\t\t\t\t\t

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...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

Blog: DSRU Global Pharmacovigilance Observatory – An Introduction<\/h3>\n\t\t\t\t\t

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...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

12 week dosing interval for the two COVID-19 vaccines in the UK – an analogy<\/h3>\n\t\t\t\t\t

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...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

Blog: Decision regarding dosing of COVID-19 vaccines<\/h3>\n\t\t\t\t\t

Saad Shakir on Pharmacovigilance: Decision regarding dosing of COVID-19 vaccines Since last week\u2019s approval of the AstraZeneca\/ Oxford University COVID-19 vaccine, there has been some...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

Blog: Reporting rate of serious allergic reactions with the Pfizer\/BioNTech vaccine – to put things in perspective<\/h3>\n\t\t\t\t\t

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...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

Blog: The new SARS-CoV-2 variant – comments on transmission, virulence and response to COVID-19 drugs and vaccines<\/h3>\n\t\t\t\t\t

Saad Shakir writes: Speed of transmission - it is public knowledge that it transmits much faster with significantly higher R value. Virulence - There are...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

Blog: Anaphylaxis following immunisation with Pfizer\/BioNTech COVID-19 vaccine \u2013 comments on the pharmacovigilance and clinical aspects of the association<\/h3>\n\t\t\t\t\t

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...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

Blog: Anaphylactoid reactions with Pfizer\/BioNTech COVID-19 vaccine: pharmacovigilance perspective and public information needs<\/h3>\n\t\t\t\t\t

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...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

Swift response by regulator to anaphylactoid response in two COVID-19 vaccinees<\/h3>\n\t\t\t\t\t

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...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

It is essential to monitor the post-authorisation safety and efficacy of new COVID-19 vaccines<\/h3>\n\t\t\t\t\t

We welcome today\u2019s approval of the Pfizer\/ BioNTech COVID-19 vaccine by the UK\u2019s medicines regulator, the MHRA. This is wonderful news and a triumph for...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

Vaccine manufacturers’ safety commitment emphasises importance of post-authorisation safety and effectiveness monitoring<\/h3>\n\t\t\t\t\t

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...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

Post-authorisation safety and effectiveness studies will complement the pre-marketing studies for vaccines for COVID-19.<\/h3>\n\t\t\t\t\t

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...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

How pharmacovigilance needs to adapt in order to handle the challenges of advanced therapies and the COVID-19 pandemic<\/h3>\n\t\t\t\t\t

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...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

Cytokine Storm: A major killer in patients with severe COVID-19 infection.<\/h3>\n\t\t\t\t\t

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. ...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

Is the UK facing its own opioid crisis?<\/h3>\n\t\t\t\t\t

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;...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

MEDS: The DSRU Centre for Methods, Evidence and Regulations in Drug Safety<\/h3>\n\t\t\t\t\t

Saad Shakir writes: A new centre has been established at the DSRU to focus and expand the Unit\u2019s methodological research. The mission of the DSRU...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

DSRU Consultancy: World class science at a not-for-profit price<\/h3>\n\t\t\t\t\t

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...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

Measuring the Impact of Pharmacovigilance<\/h3>\n\t\t\t\t\t

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,...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

What are the main objectives of PASS studies for Risk Management?<\/h3>\n\t\t\t\t\t

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...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

Designing studies for risk management plans that are acceptable to European regulators<\/h3>\n\t\t\t\t\t

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...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

DSRU attends the RCGP Annual Conference in Harrogate<\/h3>\n\t\t\t\t\t

A DSRU team attended the Annual Conference of the Royal College of General Practitioners (RCGP) in Harrogate on 6th - 8th October 2016. The conference...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

Pharmacovigilance Science in the UK and Europe in the years to come<\/h3>\n\t\t\t\t\t

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...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\t\t\t

\t\n\t\t\t\t
\n\t\t\t\t\t
<\/div>\n\t\t\t\t\t\"\"\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

<\/p>\n \t

A Network of Studies – Risk Management and Risk Minimisation Studies Conducted by a Network of European Countries<\/h3>\n\t\t\t\t\t

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...<\/p>\n\t\t\t\t\t

Continue reading<\/a><\/p>\n <\/div>\n\t\t <\/div>\n\t\n\t\t\t\t\n\t\n\n\t\t\n\t<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":4,"featured_media":0,"parent":22,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"page-directory.php","meta":{"_acf_changed":false,"footnotes":""},"coauthors":[],"class_list":["post-4370","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nBlogs | Latest Developments in Pharmacovigilance | DSRU<\/title>\n<meta name=\"description\" content=\"Discover thought-provoking discussions and insights into the pharmacovigilance and pharmacoepidemiology sector in the DSRU's blogs.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.dsru.org\/information-news\/blog\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Blogs | Latest Developments in Pharmacovigilance | DSRU\" \/>\n<meta property=\"og:description\" content=\"Discover thought-provoking discussions and insights into the pharmacovigilance and pharmacoepidemiology sector in the DSRU's blogs.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.dsru.org\/information-news\/blog\/\" \/>\n<meta property=\"og:site_name\" content=\"DSRU\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/DrugSafetyResearchUnit\" \/>\n<meta property=\"article:modified_time\" content=\"2023-03-23T11:24:30+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:site\" content=\"@DSRUDrugSafety\" \/>\n<meta name=\"twitter:label1\" content=\"Estimated reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 minute\" \/>\n\t<meta name=\"twitter:label2\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data2\" content=\"Emily Axten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.dsru.org\\\/information-news\\\/blog\\\/\",\"url\":\"https:\\\/\\\/www.dsru.org\\\/information-news\\\/blog\\\/\",\"name\":\"Blogs | Latest Developments in Pharmacovigilance | DSRU\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.dsru.org\\\/#website\"},\"datePublished\":\"2022-12-16T09:48:42+00:00\",\"dateModified\":\"2023-03-23T11:24:30+00:00\",\"description\":\"Discover thought-provoking discussions and insights into the pharmacovigilance and pharmacoepidemiology sector in the DSRU's blogs.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.dsru.org\\\/information-news\\\/blog\\\/#breadcrumb\"},\"inLanguage\":\"en-GB\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.dsru.org\\\/information-news\\\/blog\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.dsru.org\\\/information-news\\\/blog\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/www.dsru.org\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Information & News\",\"item\":\"https:\\\/\\\/www.dsru.org\\\/information-news\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Blogs\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/www.dsru.org\\\/#website\",\"url\":\"https:\\\/\\\/www.dsru.org\\\/\",\"name\":\"DSRU\",\"description\":\"The UK\u2019s leading pharmacovigilance and pharmacoepidemiology unit.\",\"publisher\":{\"@id\":\"https:\\\/\\\/www.dsru.org\\\/#organization\"},\"alternateName\":\"Drug Safety Research Unit\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/www.dsru.org\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-GB\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/www.dsru.org\\\/#organization\",\"name\":\"DSRU\",\"alternateName\":\"Drug Safety Research Unit\",\"url\":\"https:\\\/\\\/www.dsru.org\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-GB\",\"@id\":\"https:\\\/\\\/www.dsru.org\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/www.dsru.org\\\/wp-content\\\/uploads\\\/2022\\\/01\\\/cropped-DSRU_Branding.png\",\"contentUrl\":\"https:\\\/\\\/www.dsru.org\\\/wp-content\\\/uploads\\\/2022\\\/01\\\/cropped-DSRU_Branding.png\",\"width\":250,\"height\":115,\"caption\":\"DSRU\"},\"image\":{\"@id\":\"https:\\\/\\\/www.dsru.org\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/DrugSafetyResearchUnit\",\"https:\\\/\\\/x.com\\\/DSRUDrugSafety\",\"https:\\\/\\\/www.linkedin.com\\\/company\\\/drug-safety-research-unit\\\/\",\"https:\\\/\\\/www.instagram.com\\\/drugsafetyresearchunit\\\/\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Blogs | Latest Developments in Pharmacovigilance | DSRU","description":"Discover thought-provoking discussions and insights into the pharmacovigilance and pharmacoepidemiology sector in the DSRU's blogs.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.dsru.org\/information-news\/blog\/","og_locale":"en_GB","og_type":"article","og_title":"Blogs | Latest Developments in Pharmacovigilance | DSRU","og_description":"Discover thought-provoking discussions and insights into the pharmacovigilance and pharmacoepidemiology sector in the DSRU's blogs.","og_url":"https:\/\/www.dsru.org\/information-news\/blog\/","og_site_name":"DSRU","article_publisher":"https:\/\/www.facebook.com\/DrugSafetyResearchUnit","article_modified_time":"2023-03-23T11:24:30+00:00","twitter_card":"summary_large_image","twitter_site":"@DSRUDrugSafety","twitter_misc":{"Estimated reading time":"1 minute","Written by":"Emily Axten"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.dsru.org\/information-news\/blog\/","url":"https:\/\/www.dsru.org\/information-news\/blog\/","name":"Blogs | Latest Developments in Pharmacovigilance | DSRU","isPartOf":{"@id":"https:\/\/www.dsru.org\/#website"},"datePublished":"2022-12-16T09:48:42+00:00","dateModified":"2023-03-23T11:24:30+00:00","description":"Discover thought-provoking discussions and insights into the pharmacovigilance and pharmacoepidemiology sector in the DSRU's blogs.","breadcrumb":{"@id":"https:\/\/www.dsru.org\/information-news\/blog\/#breadcrumb"},"inLanguage":"en-GB","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.dsru.org\/information-news\/blog\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.dsru.org\/information-news\/blog\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.dsru.org\/"},{"@type":"ListItem","position":2,"name":"Information & News","item":"https:\/\/www.dsru.org\/information-news\/"},{"@type":"ListItem","position":3,"name":"Blogs"}]},{"@type":"WebSite","@id":"https:\/\/www.dsru.org\/#website","url":"https:\/\/www.dsru.org\/","name":"DSRU","description":"The UK\u2019s leading pharmacovigilance and pharmacoepidemiology unit.","publisher":{"@id":"https:\/\/www.dsru.org\/#organization"},"alternateName":"Drug Safety Research Unit","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.dsru.org\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-GB"},{"@type":"Organization","@id":"https:\/\/www.dsru.org\/#organization","name":"DSRU","alternateName":"Drug Safety Research Unit","url":"https:\/\/www.dsru.org\/","logo":{"@type":"ImageObject","inLanguage":"en-GB","@id":"https:\/\/www.dsru.org\/#\/schema\/logo\/image\/","url":"https:\/\/www.dsru.org\/wp-content\/uploads\/2022\/01\/cropped-DSRU_Branding.png","contentUrl":"https:\/\/www.dsru.org\/wp-content\/uploads\/2022\/01\/cropped-DSRU_Branding.png","width":250,"height":115,"caption":"DSRU"},"image":{"@id":"https:\/\/www.dsru.org\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/DrugSafetyResearchUnit","https:\/\/x.com\/DSRUDrugSafety","https:\/\/www.linkedin.com\/company\/drug-safety-research-unit\/","https:\/\/www.instagram.com\/drugsafetyresearchunit\/"]}]}},"_links":{"self":[{"href":"https:\/\/www.dsru.org\/wp-json\/wp\/v2\/pages\/4370","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.dsru.org\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.dsru.org\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.dsru.org\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.dsru.org\/wp-json\/wp\/v2\/comments?post=4370"}],"version-history":[{"count":6,"href":"https:\/\/www.dsru.org\/wp-json\/wp\/v2\/pages\/4370\/revisions"}],"predecessor-version":[{"id":4422,"href":"https:\/\/www.dsru.org\/wp-json\/wp\/v2\/pages\/4370\/revisions\/4422"}],"up":[{"embeddable":true,"href":"https:\/\/www.dsru.org\/wp-json\/wp\/v2\/pages\/22"}],"wp:attachment":[{"href":"https:\/\/www.dsru.org\/wp-json\/wp\/v2\/media?parent=4370"}],"wp:term":[{"taxonomy":"author","embeddable":true,"href":"https:\/\/www.dsru.org\/wp-json\/wp\/v2\/coauthors?post=4370"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}