The DSRU welcomes the UK’s decision to have continued involvement in EU medicines regulation after Brexit. The UK Parliament voted last night for the UK to participate in the regulatory network operated by the European Medicines Agency (EMA) after it leaves the EU. The government confirmed that it would make an “appropriate financial contribution” in return for this level of participation. The DSRU believes that the overall aim should be to ensure that citizens of the UK and the EU continue to gain access to the best and most innovative medicines. The DSRU will continue to support the MHRA and the [...]
About dsruThis author has not yet filled in any details.
So far dsru has created 74 blog entries.
Do you need a registry in order to fulfill your post-authorisation regulatory requirements? Look no further! We have been setting up and running registry studies for many years, including drug, disease and pregnancy registries. For further details click here or get in touch.
Book your place on the course webpage using coupon code ‘DSRUSUMMER18’ by Friday 8th June 2018 to enjoy a 20% discount on registration fees*. Training included in this offer includes: Big Data for Pharmacovigilance conference Medication Errors course Global Regulations course Back to Basics in Pharmacovigilance course Introduction to Pharmacoepidemiology course …and many other courses. Click here to view our course calendar. *20% discount does not apply to postgraduate, PMST or GP Masterclass bookings. Not to be used in conjunction with any other offer. Offer available until 11:59pm UK time on Friday 8th June 2018.
For a limited time only we are offering you a 20% discount on all course and conference bookings. Book your place on the course webpage using coupon code ‘DSRUSUMMER18’by Friday 8th June 2018 to enjoy a 20% discount on registration fees*. The discount can be used to book our Big Data for Pharmacovigilance conference, our Medication Errors course, Global Regulations course, Back to Basics in Pharmacovigilance and many other courses. Click here to view our course calendar. *20% discount does not apply to postgraduate or PMST bookings. GP Masterclass is excluded from the offer. Not to be used in conjunction with any other offer. Offer available until 11:59pm UK time on Friday 8th June 2018. [...]
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 is to protect patients from the hazards of medicines. While significant advances have been made in our field in the last 60 years, far more remains to be done. Our aims are to both evaluate and improve on our existing methods, to modify some of our existing approaches and propose new methods. A small team of Physicians, Epidemiologists and Biomedical Scientists will work at MEDS. We will expand the efforts by allocating internal resources, establishing [...]
The first conference on “Big Data for Pharmacovigilance” will take place in London on 20 – 21 June. The conference programme includes some great speakers covering Big Data from all angles. There’s something for everyone! Highlights include: Using real world evidence as Big Data Abhimanyu Verma, Novartis Natural language processing and drug-drug interactions Nicholas Tatonetti, Columbia University Opportunities and Barriers for Big Data in Pharmacovigilance Andrew Bate, Pfizer Danish biobanks in the context of Big Data Estrid Høgdall, Danish Biobank, Herlev Hospital Linking Data Within and Across Data Sets Tomas Bergvall, Uppsala Monitoring Centre Sentinel Jeff Brown, Harvard Medical School Reproducibility and Transparency Jeremy Rassen, Aetion, USA Big [...]
Come and see us in the exhibition hall at Booth 112 to find out about our post-authorisation safety studies (PASS), as well as: DSRU Consultancy ECHO – our PV initiative for mental health products Our European network studies …and our wide range of other studies. DSRU Director, Professor Saad Shakir, will be chairing and speaking in the session on “Measuring the Impact of Pharmacovigilance in the EU” (S0503) on Wednesday 18th April at 1600 – 1730. He will also offer free consultancy in pharmacoepidemiology and risk management during the conference. Contact us to arrange an appointment.
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 team of epidemiologists, physicians, biomedical scientists, IT and data management professionals, who provide the consultancy work individually or as a team. We advise all kinds of companies from the some of the largest pharmaceutical companies in the world to medium and small size companies. DSRU Consultancy provides advice in Europe based on the many strengths of our organisation. These include: Internationally recognised expertise in pharmacovigilance, pharmacoepidemiology, risk management and risk minimisation. In-depth understanding and experience [...]
The results from our study on evidence used to support product withdrawals and other regulatory actions have just been published in BMJ Open. The study concerned 18 medicinal products that were withdrawn, revoked or suspended in the EU for safety reasons following the implementation of new pharmacovigilance legislation on 1 July 2012 until 31 December 2016. We examined the publicly-available evidence cited and found that several sources of evidence supported most (17/18) regulatory actions. Our results suggested that the number of drug withdrawals has dropped since July 2012 and that there has been a small reduction in the time taken to reach [...]
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, Risk Management and Risk Minimisation are only a few examples of fairly recent developments. The effects of these and other developments in Pharmacovigilance are real and there are metrics that measure these processes. However the actual impact of Pharmacovigilance on reducing serious morbidity and mortality has not been measured. PRAC, EMA and ENCePP are interested in measuring the impact of pharmacovigilance process. An ENCePP Special Interest Group on Impact has been formed, of which the DSRU [...]