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.
Joint PSI, EFSPI & ASA BIOP Webinar: Estimands
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on this topic to date.
Discover your potential by working as a Covance Senior Principal / Principal Biostatistician. You'll enjoy a varied role working for different sponsors across several therapeutic areas, leading projects and mentoring junior members of the department.
Biometrics at AstraZeneca provides the data that influences decisions on how we roll back the frontiers of science to bring life-changing medicines to the world. We are at the heart of design, analytics and interpretation of AstraZeneca’s portfolio.