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 [...]
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. [...]
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 [...]
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.
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 [...]
The newly updated GVP Module V now includes clarification of the scope of RMPs in relation to important identified or potential risks and missing information. Join us to hear from speakers including members of the EMA team who wrote the revised GVP Module V and updated the RMP template, as well as QPPV and other pharma staff. The day will include a Question & Answer session with the expert panel of speakers. The training day will take place on 18th January at the British Medical Association, London. You can find out more and book your place here. Confirmed speakers: Emil Cochino, EMA Jane [...]
We're delighted to announce the launch of DSRU Consultancy: Pharmacovigilance, Pharmacoepidemiology and Risk Management. DSRU Consultancy provides advice on strategies, study designs and options for post-marketing Pharmacovigilance, Pharmacoepidemiology and Risk Management Planning. This initiative builds on the DSRU's vast experience in studying a wide range medicines and working with companies of all sizes. The DSRU has an impeccable track record of providing impartial advice and has a good understanding of regulatory requirements. We offer a flexible approach, from provision of advice alone through to designing and conducting a PASS study. We may advise use of our own data sources or of [...]
The meeting report has just been published for our 9th Biennial Signal Detection Conference, which took place in June. The report details some of the highlights and themes of the event, including Signal Detection in the Age of Big Data, new methodologies and updates on well-established approaches. DSRU Signal Detection Conferences have built up a loyal following amongst the Signal Detection community worldwide, since the first event was held in 2001. Read the report here: http://rdcu.be/uR2t The next Signal Detection conference is due to take place in summer 2019, but watch this space for details of our new "Big Data in [...]
Our biennial Signal Detection Conferences have built up a loyal following in the pharmacovigilance community since the first conference in 2001. It was a pleasure to see many familiar faces at last week’s 9th Signal Detection Conference, as well as to welcome many newcomers. The majority of delegates attended the pre-conference tutorial day, which had been redesigned to bring beginners right up to speed by start of the main conference.The first day of the main conference concentrated on true signal detection, starting with a thorough update from the EMA’s Aniello Santoro including GVP Module IX and the EudraVigilance Data Analysis System. [...]
Nigel Hawkes’ feature in the BMJ (http://www.bmj.com/content/357/bmj.j2168 published 17th May 2017) outlines some of the concerns raised at the DSRU’s Forum on UK Pharmacovigilance post-Brexit, which was held in London on 26th April. He notes that while the European Medicines Agency (EMA) would have to be relocated in order to remain within the EU, UK pharmacovigilance specialists faced an uncertain future. DSRU Director, Saad Shakir, highlighted the need to avoid overlooking pharmacovigilance and medicines regulation amongst the many other niche areas where Brexit decisions need to be made by the government. […]