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 click here for the course flyer.
Registration:
| PSI member |
£595 + VAT |
£695 + VAT |
| PSI non-Member |
£690 + VAT (includes PSImembership) |
£790 + VAT (includes PSI membership) |
Please click here to register.
Please email PSI@mci-group.com to advise of any dietary requirements and accessibility issues ASAP.