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.
Upcoming Events
A PSI ToxSIG webinar - Big Data, Data Science, AI and other buzzwords: What does the Data-Driven Hype mean for Pharmaceutical Analytics?
The last 15 years has seen a massive shift in the role of data and analytics, driven by the increased hype around big data, data science, machine learning and AI. This presents both challenges and opportunities for analytic teams. This webinar will strip back the hype to look at what these buzzwords really mean, and talk about the impact this is having on the role, remit and operating model of analytic teams in the life sciences industry.
An opportunity to meet statisticians from across the pharmaceutical industry in a relaxed and informal setting. An exciting program of events and a chance to work in small groups on a data analysis challenge. Lunch provided.
A PSI Training Course - Practical Approaches to Designing Adaptive Clinical Trials
This hands-on course will provide a deep dive into 4 software packages used to design adaptive clinical trials.
The course will start by providing a general overview of adaptive designs, explaining the different type of adaptations possible and the benefits of each design. Following this, participants will be given the opportunity to have a go at designing trials in R (using RPACTS), EAST, FACTS, and nQuery.
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.
This course is aimed at Statisticians and Programmers experienced in SAS, but little or no experience with R.
An Introduction to R studio and the R language, statistical graphics, programming statistical models, simulations and more…
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.
