PSI Journal Club: Limitations and Challenges with Mixed Model Repeated Measures (MMRM) Analysis
Moses Mwangi and Florian Lasch present their recent work on MMRM, with discussion lead by Geert Molenberghs.
Daphne Lin (FDA)
Yolanda Barbachano (MHRA)
Khadija Rantell (MHRA)
Natasha Jarrett
Andy Stone
Please click here to view the flyer.
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.
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.
Moses Mwangi and Florian Lasch present their recent work on MMRM, with discussion lead by Geert Molenberghs.
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.
Talks from speakers will cover an introduction to HTA and indirect comparisons for value assessment before focusing in more specifically on topics related to the use of indirect treatment comparisons for patient access.
Talks from the speakers will cover the use of R in a programming community, submitted to regulators using R, and also programming beyond R in C++ and Julia.
This course is aimed at clinical trial statisticians who are new to or with limited experience of machine learning. Attendees will learn about a range of topics in machine learning, including practical sessions in R.
This webinar will explore two different approaches to Correlates of Protection in vaccine development.
The event will open with an overview on drug development in women’s health from a clinician perspective. This talk is followed by talks about statistical challenges when planning IVF studies and analysing the menstrual cycles.
This webinar will provide an overview of surrogacy for licensing and reimbursement. In turn, the need of extensions of the SPIRIT and CONSORT statement will be defined and outlined, with case studies to support.
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.
An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.