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: 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.
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.
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
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.
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Speaker |
Biography |
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Ines Antunes dos Reis |
Inês has been a statistical assessor at the Medicines and Healthcare products Regulatory Agency (MHRA) since 2018. Her work focuses on assessment of marketing authorisation applications, providing scientific advice to companies, assessment of clinical investigation applications, and participating in the development of regulatory guidelines. She has over 7 years of experience in the regulatory system, having previously worked for the European Medicines Agency (EMA). She supported the ICH E9(R1) expert working group on Estimands and Sensitivity Analysis in Clinical Trials and contributed to the E9(R1) training materials published in the ICH website. |
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Yolanda has worked as a statistician for nearly two decades, her experience spans from academia to regulatory bodies and now industry. Her interest in regulatory guidance developed whilst working over 10 years as a statistical assessor at the MHRA, and as part of the EMA system. Yolanda now works at BioNTech where she has to consider regulatory requirements for other regions. She has a PhD in statistics and a BSc in mathematics, both from the University of Sussex. |
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Kerry Gordon has been in the health sector for over 40 years, mostly in the world of statistics and programming. As a past Chair of PSI, Kerry has sat on the PSI Board of Directors and has also served on the PSI Scientific, Website, Regulatory and Training subcommittees. After starting out with the NHS, he moved into the industry at (what is now) Novartis. Then, after a spell at the University of Kent, he worked for Quintiles (latterly IQVIA) for over 20 years and at Parexel for a few years. Kerry joined PHASTAR, a niche Biometrics CRO, in July last year as an Engagement Head, looking after specific customer accounts. |
