*A PSI Training Course: Regulatory Interactions for Statisticians*
*Presenters from the FDA, MHRA and Industry*
*Venue: Crowne Plaza, Heathrow*
*Date: 26th-27th September **2018*
For further details or to register: http://www.psiweb.org and click on
events
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.
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
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