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.
