DSRU support to small and medium companies on information, analysis and studies on Observational and Real World Data Large pharmaceutical companies allocate resources to observational and real world data and use these sources at all stages of drug development. Smaller pharmaceutical companies may not be able to do the same. However, they do not need to be left out. The DSRU has a highly experienced team of epidemiologists, physicians and medical research scientists who can support smaller companies to obtain such data, analyse it or conduct formal studies if needed. This can be done on a regular or ad hoc [...]
Our 4th European Conference on Monitoring the Effectiveness of Risk Minimisation is coming up on 20-21st November, preceded by a tutorial day on 19th November. While additional risk minimisation methods have now become established, in this year’s conference we will look at new methods for determining whether they actually accomplish what they set out to achieve, as well as risk minimisation methods applicable to the latest generation of medicines. Topics include: Developing REMS and additional risk minimisation measures for the same product (Dr Anne-Ruth van Troostenburg de Bruyn, Gilead) Use of surveys to evaluate the effectiveness of risk minimisation measures: a report [...]
We are delighted to launch our new website. The homepage has been simplified to allow easy access to our three key areas of expertise: Studies, DSRU Consulting and Training. The Studies section outlines our capabilities in observational studies, including drug utilisation, CPRD, risk minimisation, ECHO for mental health products, MEP for methodological research, event monitoring studies in primary or secondary care (MPEM and SCEM), registries and much more. The DSRU Consulting section outlines the advice we provide to companies both big and small in risk management, pharmacoepidemiology and pharmacovigilance. There is also information on our special consultancy service in pharmacoepidemiology for [...]
The DSRU has a unique method for conducting post-authorisation safety studied (PASS) on medicines prescribed in hospital or specialist care. This SCEM (Specialist Cohort Event Monitoring) methodology allows us to work directly with specialists and health care teams in hospitals in order to recruit patients to the observational study and collect utilisation and safety data. We are now working on our fourth SCEM study. This method is ideal for studying the safety or utilisation of medicines that are initially prescribed in hospital or specialist care and later transferred to primary care. We work closely with specialists in the relevant [...]
The DSRU team will be attending the 34th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE) in Prague next week Visit the DSRU Booth (#26) to find out about our capabilities: DSRU Consultancy ECHO – for observational studies on mental health products World-class PASS studies in primary and secondary care Listen to our oral presentations (see abstracts here) See our research posters (see abstracts here)
We are pleased to announce that Dr Vicki Osborne is the DSRU’s new Principal Research Fellow. Vicki rejoins the DSRU after three years spent gaining her PhD in Epidemiology at the University of Florida. Vicki also has a Biomedical Science BSc from the University of Portsmouth and an Epidemiology MSc from the London School of Hygiene and Tropical Medicine. Vicki has over 10 years of experience in the fields of pharmacovigilance and pharmacoepidemiology, and has many significant publications and scientific contributions to the field. Vicki will provide pharmacoepidemiology expertise and scientific support, alongside our team of experienced epidemiologists, medics and [...]
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.