This course will give an overview of ICH guidelines for all statisticians in the setting of drug development trials and drug approval in the pharmaceutical industry.
Venue: Crowne Plaza Hotel, Stockley Road, West Drayton, London UB7 9NA Presenters: Christine Fletcher (Amgen), Kerry Gordon (IQVIA), James Matcham (AZ) and Caroline Pothet (GSK). Course timings: 10:00-17:30 (registration from 09:30) on day 1
09:00-16:00 on day 2
The course will describe key guidelines from regulatory bodies such as EMA, FDA, PDMA and CDE. The focus of the course will be on the content of ICH E9 (Statistical Principles for Clinical Trials) and ICH E10 (Choice of Control Group in Clinical Trials), ICH E6 (Good Clinical Practice) and E17 (Multi-Regional Clinical Trials) but other key regulatory guidance documents will also be highlighted. The course will also include workshops, a Q&A session and guidance on how to seek advice from regulators.
Please email PSI@mci-group.com to advise of any dietary requirements and accessibility issues ASAP.
PSI Scientific Committee Webinar - Longitudinal modelling: Time to take the next step?
Longitudinal data, i.e. data that arises from repeated observations of the variable over a period of time, has long been put forward as one way to improve to the efficiency of drug development. However, even though there is a rich statistical methodology for longitudinal data, there is no full, wholehearted uptake of these methods in pharmaceutical statistics..
PSI Webinar - Main statistical approaches for quantitative decision-making in drug development
We performed a survey among pharmaceutical companies, targeting people with different profiles (statisticians, non-statisticians and decision-makers) working at different stages of the clinical development (study level, development level or portfolio level).
PSI Training Course - Bayesian Practical Course using R and SAS
This practical training course will give a deep dive into performing Bayesian analyses in R and SAS. It is aimed at statisticians who need to be able to conduct Bayesian analyses as part of their day to day work. By the end of the course participants will be able to conduct their own analyses.
The ITIT course will take 25 delegates new to the industry on a complete drug development experience from discovery to marketing. They will visit 6 companies from October 2020 to July 2021 to learn about 6 topics from experts in their field. The ITIT course will have 6 sessions in continental Europe and 3 - 4 sessions in the UK. It promises to be a truly memorable course.
Are you interested in bringing your established consulting and statistical analysis skills to a thriving independent company? If so, BresMed is offering an exciting opportunity to join our Statistics team.
Are you interested in working in a cutting-edge industry, where you can develop globally valued skills and apply your maths and statistics knowledge to improving healthcare? If so, BresMed is offering an exciting opportunity to join our Statistics team.