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
• 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 on or before 15th August:
£595 + VAT
£690 + VAT
Registration after 15th August:
£695 + VAT
£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 firstname.lastname@example.org to reserve a room.
Joint PSI, EFSPI & ASA BIOP Webinar: Estimands
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on this topic to date.
Discover your potential by working as a Covance Senior Principal / Principal Biostatistician. You'll enjoy a varied role working for different sponsors across several therapeutic areas, leading projects and mentoring junior members of the department.
Biometrics at AstraZeneca provides the data that influences decisions on how we roll back the frontiers of science to bring life-changing medicines to the world. We are at the heart of design, analytics and interpretation of AstraZeneca’s portfolio.