Event

PSI Training Course: Regulatory Guidelines for Statisticians

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Date: Wednesday 2nd & Thursday 3rd October 2024
Time: Day 1: 09:00-17:00 | Day 2: 09:00-16:00 BST
Location: This Course will be taught in-person, at Crowne Plaza London Heathrow T4 (Terminal 4, Swindon Road, Hounslow, TW6 3FJ, United Kingdom)
Speakers: Chrissie Fletcher (GSK), Ines Antunes dos Reis (MHRA), Yolanda Barbachano (BioNTech) and Kerry Gordon (Phastar).

Who is this event intended for? Statisticians who would like to enhance their knowledge of the latest ICH and other global and regional regulatory guidelines. 
What is the benefit of attending? Participants will either gain or expand upon their knowledge and awareness of the regulatory environment and associated guidelines.

Cost

Early Bird PSI Members = £370+VAT
PSI Members = £410+VAT

Early Bird Non-Members = £480+VAT
Non-Members = £520+VAT
*Please note: Non-Member rates include PSI membership until 31 Dec. 2025.

Registration

To book your place, please click here.

Please note
:
- There are a limited number of places for this in-person event. Due to its popularity, we do kindly ask you to consider both the timings and location before committing to attend.
Registration does not include hotel accommodation. If a hotel is required (as this Course runs over two consecutive days), delegates will need to book their own accommodation separately. As the Course is being held at the Crowne Plaza London Heathrow T4, we recommend booking your accommodation here. Additionally, there is a daily charge for parking, which can also be booked with the Reservations team. To make your booking, please contact the Crowne Plaza reservations team via the following:
Email: Reservations5@cpheathrowt4.com
Telephone: 0203 971 4182 or 0203 971 4181

Overview

The course will describe key ICH guidelines of main interest to statisticians, as well as guidance documents from regulatory bodies such as EMA, FDA, PMDA, MHRA and CDE.  The focus of the course will be on the content of ICH E9 (Statistical Principles for Clinical Trials), ICH E9(R1) (Estimands and Sensitivity Analysis in Clinical Trials), ICH E10 (Choice of Control Group in Clinical Trials), ICH E6 (Good Clinical Practice), ICH E17 (Multi-Regional Clinical Trials), and ICH E20 (Adaptive 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. 

Speaker details

Information on our Speakers will be released shortly.

 

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