BEGIN:VCALENDAR VERSION:2.0 METHOD:PUBLISH PRODID:-//Telerik Inc.//Sitefinity CMS 13.3//EN BEGIN:VEVENT DESCRIPTION:Presented by:\nDaphne Lin (FDA)\n\n\n\nYolanda Barbachano (MHRA )\n\n\n\nKhadija Rantell (MHRA)\nNatasha Jarrett\nAndy Stone\n\n\nPlease c lick here \;to view the flyer.\nThe course objective is to inform stat isticians about the likely interactions they might have with regulatory ag encies\, both during a submission and at other times during drug developme nt\, and give advice on how to make these interactions most effective. The course will focus on clinical development.\nThe course is primarily targe ted at project statisticians who interact with regulators\, but would also be suitable for those who may move into this role in the near future. \nT he course will be presented by experienced statisticians from the MHRA\, F DA and those with expansive pharmaceutical company employment and represen tatives from a company regulatory affairs department. The course will cons ist of lectures\, practical examples and discussions. There will not be an y computer exercises.\n\n\nCourse runs from:\nDay 1: 10:00 &ndash\; 17:00 (registration from 9:30) \; \;\nDay 2: 09:00 &ndash\; 16:00 \; \n\n\nKey Topics:\n\n&bull\; Introduction to the regulatory agencies\n&bul l\; Interactions between EU and US regulators and statisticians at each st age of development\n&bull\; Overview of regulatory practices in other regi ons\n\nRegistration:\n\n\n \n \n \n Regist ration on or before 15th August:\n \n \n \n  \;PSI Member\n  \;£\;595 + VAT\n \n \n  \;Non-Member\n  \;£\;690 + V AT\n \n \n  \;Registration after 15th August: \n \n \n \n  \;PSI Member\n  \;£\;695 + VAT\n \n \n  \;Non- Member\n  \;£\;790 + VAT\n \n \n\n\nRegistra tion has now closed.\n\nRegistration costs include lunch and refreshments. PSI are holding a limited number of hotel rooms on 25th and 26th Septembe r which will be allocated on a first come first served basis. Please conta ct \;psi@mci-group.com \;to reserve a room. \; DTEND;VALUE=DATE:20180928 DTSTAMP:20240329T012652Z DTSTART;VALUE=DATE:20180926 LOCATION: SEQUENCE:0 SUMMARY:Regulatory Interactions for Statisticians UID:RFCALITEM638472724124479758 X-ALT-DESC;FMTTYPE=text/html:
Daphne Lin (FDA)
\n
\n
\n
\nYol
anda Barbachano (MHRA)
\n
\n
\n
\nKhadija Rantell (M
HRA)
\nNatasha Jarrett
\nAndy Stone
\n
\n
\nPleas
e click here \;to view the f
lyer.
The course objective is to inform statisticians about the li kely interactions they might have with regulatory agencies\, both during a submission and at other times during drug development\, and give advice o n how to make these interactions most effective. The course will focus on clinical development.
\nThe course is primarily targeted at project statisticians who interact with regulators\, but would also be suitable fo r those who may move into this role in the near future.
\nThe cours
e will be presented by experienced statisticians from the MHRA\, FDA and t
hose with expansive pharmaceutical company employment and representatives
from a company regulatory affairs department. The course will consist of l
ectures\, practical examples and discussions. There will not be any comput
er exercises.
\n
\n
Day 1: 1
0:00 &ndash\; 17:00 (registration from 9:30) \; \;
\nDay 2: 0
9:00 &ndash\; 16:00 \;
\n
\nKey Topics:
\n
\n&bull\; Introduct
ion to the regulatory agencies
\n&bull\; Interactions between EU and
US regulators and statisticians at each stage of development
\n&bull\
; Overview of regulatory practices in other regions
\n
\nRegistration:
\n<
/p>\n
\n Registration on or before 15th August:\n | \n|
 \;PSI Member | \n \;£\;595 + VAT\n |
 \;Non-Member | \ n \;£\;690 + VAT | \n
 \;Regis
tration after 15th August: \n | \n |
 \;PSI Member | \n \;£\;695 + VAT | \n
 \;Non-Member | \n \;£\;790 + VAT | \n
\nRegistration has now closed.
\n
\nRegistration costs include lunch and refreshments. PSI are ho
lding a limited number of hotel rooms on 25th and 26th September which wil
l be allocated on a first come first served basis. Please contact \;psi@mci-group.com \;to reserve a
room. \;