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.
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.
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.
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.
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.
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
PSI Mentoring 2025
Date: Ongoing 6 month cycle beginning late April/early May 2024
Are you a member of PSI looking to further your career or help develop others - why not sign up to the PSI Mentoring scheme? You can expand your network, improve your leadership skills and learn from more senior colleagues in the industry.
PSI Training Course: Mixed Models and Repeated Measures
This course is presented through lectures and practical sessions using SAS code. It is suitable for statisticians working on clinical trials, who already have a good understanding of linear and generalised linear models.
Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This is an interactive online training workshop providing an in-depth review of the estimand framework as laid out by ICH E9(R1) addendum with inputs from estimand experts, case studies, quizzes and opportunity for discussions. You will develop an estimand in a therapeutic area of interest to your company. In an online break-out room, you will join a series of team discussions to implement the estimand framework in a case study, aligning estimands, design, conduct, analysis, (assumptions + sensitivity analyses) to the clinical objective and therapeutic setting.
Maths Meets Medicine: Exploring Careers in the Pharmaceutical Industry
This session will showcase how careers in pharmaceutical statistics can be both rewarding and impactful, with a focus on how mathematics is integral to the development of medicines. Students will hear from industry experts, explore diverse career paths, and learn why continuing to study math is key to unlocking exciting opportunities in the healthcare sector.
Dissolution Testing: Time for Statistical (r)Evolution
Webinar dedicated to the topic of dissolution of oral solid dosage forms; opportunity to hear from statisticians working in the CMC field, with open question and answers.
In addition, the CMC Statistical Network Europe special interest group will discuss advocacy opportunities, have your say to contribute to the future direction.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.