The course objective is to inform statisticians about the likely interactions they might have with regulatory agencies, both during a submission and at other times during drug development, and give advice on how to make these interactions most effective. The course will focus on clinical development.
The course is primarily targeted at project statisticians who interact with regulators, but would also be suitable for those who may move into this role in the near future.
The course will be presented by experienced statisticians from the MHRA, FDA and those with expansive pharmaceutical company employment and representatives from a company regulatory affairs department. The course will consist of lectures, practical examples and discussions. There will not be any computer exercises.
Course runs from:
Day 1: 10:00 – 17:00 (registration from 9:30)
Day 2: 09:00 – 16:00
Key Topics:
• Introduction to the regulatory agencies
• Interactions between EU and US regulators and statisticians at each stage of development
• Overview of regulatory practices in other regions
Registration:
Registration on or before 15th August:
PSI Member
£595 + VAT
Non-Member
£690 + VAT
Registration after 15th August:
PSI Member
£695 + VAT
Non-Member
£790 + VAT
Registration has now closed.
Registration costs include lunch and refreshments. PSI are holding a limited number of hotel rooms on 25th and 26th September which will be allocated on a first come first served basis. Please contact psi@mci-group.com to reserve a room.
The course objective is to inform statisticians about the likely interactions they might have with regulatory agencies, both during a submission and at other times during drug development, and give advice on how to make these interactions most effective. The course will focus on clinical development.
The course is primarily targeted at project statisticians who interact with regulators, but would also be suitable for those who may move into this role in the near future.
The course will be presented by experienced statisticians from the MHRA, FDA and those with expansive pharmaceutical company employment and representatives from a company regulatory affairs department. The course will consist of lectures, practical examples and discussions. There will not be any computer exercises.
Course runs from:
Day 1: 10:00 – 17:00 (registration from 9:30)
Day 2: 09:00 – 16:00
Key Topics:
• Introduction to the regulatory agencies
• Interactions between EU and US regulators and statisticians at each stage of development
• Overview of regulatory practices in other regions
Registration:
Registration on or before 15th August:
PSI Member
£595 + VAT
Non-Member
£690 + VAT
Registration after 15th August:
PSI Member
£695 + VAT
Non-Member
£790 + VAT
Registration has now closed.
Registration costs include lunch and refreshments. PSI are holding a limited number of hotel rooms on 25th and 26th September which will be allocated on a first come first served basis. Please contact psi@mci-group.com to reserve a room.
The course objective is to inform statisticians about the likely interactions they might have with regulatory agencies, both during a submission and at other times during drug development, and give advice on how to make these interactions most effective. The course will focus on clinical development.
The course is primarily targeted at project statisticians who interact with regulators, but would also be suitable for those who may move into this role in the near future.
The course will be presented by experienced statisticians from the MHRA, FDA and those with expansive pharmaceutical company employment and representatives from a company regulatory affairs department. The course will consist of lectures, practical examples and discussions. There will not be any computer exercises.
Course runs from:
Day 1: 10:00 – 17:00 (registration from 9:30)
Day 2: 09:00 – 16:00
Key Topics:
• Introduction to the regulatory agencies
• Interactions between EU and US regulators and statisticians at each stage of development
• Overview of regulatory practices in other regions
Registration:
Registration on or before 15th August:
PSI Member
£595 + VAT
Non-Member
£690 + VAT
Registration after 15th August:
PSI Member
£695 + VAT
Non-Member
£790 + VAT
Registration has now closed.
Registration costs include lunch and refreshments. PSI are holding a limited number of hotel rooms on 25th and 26th September which will be allocated on a first come first served basis. Please contact psi@mci-group.com to reserve a room.
The course objective is to inform statisticians about the likely interactions they might have with regulatory agencies, both during a submission and at other times during drug development, and give advice on how to make these interactions most effective. The course will focus on clinical development.
The course is primarily targeted at project statisticians who interact with regulators, but would also be suitable for those who may move into this role in the near future.
The course will be presented by experienced statisticians from the MHRA, FDA and those with expansive pharmaceutical company employment and representatives from a company regulatory affairs department. The course will consist of lectures, practical examples and discussions. There will not be any computer exercises.
Course runs from:
Day 1: 10:00 – 17:00 (registration from 9:30)
Day 2: 09:00 – 16:00
Key Topics:
• Introduction to the regulatory agencies
• Interactions between EU and US regulators and statisticians at each stage of development
• Overview of regulatory practices in other regions
Registration:
Registration on or before 15th August:
PSI Member
£595 + VAT
Non-Member
£690 + VAT
Registration after 15th August:
PSI Member
£695 + VAT
Non-Member
£790 + VAT
Registration has now closed.
Registration costs include lunch and refreshments. PSI are holding a limited number of hotel rooms on 25th and 26th September which will be allocated on a first come first served basis. Please contact psi@mci-group.com to reserve a room.
The course objective is to inform statisticians about the likely interactions they might have with regulatory agencies, both during a submission and at other times during drug development, and give advice on how to make these interactions most effective. The course will focus on clinical development.
The course is primarily targeted at project statisticians who interact with regulators, but would also be suitable for those who may move into this role in the near future.
The course will be presented by experienced statisticians from the MHRA, FDA and those with expansive pharmaceutical company employment and representatives from a company regulatory affairs department. The course will consist of lectures, practical examples and discussions. There will not be any computer exercises.
Course runs from:
Day 1: 10:00 – 17:00 (registration from 9:30)
Day 2: 09:00 – 16:00
Key Topics:
• Introduction to the regulatory agencies
• Interactions between EU and US regulators and statisticians at each stage of development
• Overview of regulatory practices in other regions
Registration:
Registration on or before 15th August:
PSI Member
£595 + VAT
Non-Member
£690 + VAT
Registration after 15th August:
PSI Member
£695 + VAT
Non-Member
£790 + VAT
Registration has now closed.
Registration costs include lunch and refreshments. PSI are holding a limited number of hotel rooms on 25th and 26th September which will be allocated on a first come first served basis. Please contact psi@mci-group.com to reserve a room.
The course objective is to inform statisticians about the likely interactions they might have with regulatory agencies, both during a submission and at other times during drug development, and give advice on how to make these interactions most effective. The course will focus on clinical development.
The course is primarily targeted at project statisticians who interact with regulators, but would also be suitable for those who may move into this role in the near future.
The course will be presented by experienced statisticians from the MHRA, FDA and those with expansive pharmaceutical company employment and representatives from a company regulatory affairs department. The course will consist of lectures, practical examples and discussions. There will not be any computer exercises.
Course runs from:
Day 1: 10:00 – 17:00 (registration from 9:30)
Day 2: 09:00 – 16:00
Key Topics:
• Introduction to the regulatory agencies
• Interactions between EU and US regulators and statisticians at each stage of development
• Overview of regulatory practices in other regions
Registration:
Registration on or before 15th August:
PSI Member
£595 + VAT
Non-Member
£690 + VAT
Registration after 15th August:
PSI Member
£695 + VAT
Non-Member
£790 + VAT
Registration has now closed.
Registration costs include lunch and refreshments. PSI are holding a limited number of hotel rooms on 25th and 26th September which will be allocated on a first come first served basis. Please contact psi@mci-group.com to reserve a room.
Upcoming Events
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.
Topic: R Package Basics.
Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry. This month’s session, “R Package Basics,” will introduce the fundamentals of working with R packages—covering how to install, load, and manage them effectively to support data analysis and reproducible research. The session will provide a solid starting point, clarify common misconceptions, and offer valuable resources for continued learning.
Date: Ongoing 6 month cycle beginning late April/early May 2026
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 Book Club Lunch and Learn: Communicating with Clarity and Confidence
If you have read Ros Atkins’ book The Art of Explanation or want to listen to the BBC’s ‘Communicator in Chief’, you are invited to join the PSI Book Club Lunch and Learn, to discuss the content and application with the author, Ros Atkins. Having written the book within the context of the news industry, Ros is keen to hear how we have applied the ideas as statisticians within drug development and clinical trials. There will be dedicated time during the webinar to ASK THE AUTHOR any questions – don’t miss out on this exclusive PSI Book Club event!
Haven’t read the book yet? Pick up a copy today and join us.
Explanation - identifying and communicating what we want to say - is described as an art, in the title of his book. However, the creativity comes from Ros’ discernment in identifying and describing a clear step-by-step process to follow and practice. Readers can learn Ros’ rules, developed and polished throughout his career as a journalist, to help communicate complex written or spoken information clearly.
PSI Training Course: Effective Leadership – the keys to growing your leadership capabilities
This course will consist of three online half-day workshops. The first will be aimed at building trust, the backbone of leadership and a key to becoming effective. This is key to building a solid foundation.
The second will be on improving communication as a technical leader. This workshop will focus on communication strategies for different stakeholders and will involve tips on effective communication and how to develop the skills of active listening, coaching and what improv can teach us about good communication.
The final workshop will bring these two components together to help leaders become more influential. This will also focus on how to use Steven Covey’s 7-Habits, in particular Habits 4, 5 and 6, which are called the habits of communication.
The workshops will be interactive, allowing you to practice the concepts discussed. There will be plenty of time for questions and discussion. There will also be reflective time where you can think about what you are learning and how you might experiment with it.