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DTSTAMP:20240328T215055Z
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DTSTART:20210203T083000
DTEND:20210204T083000
CLASS:PRIVATE
DESCRIPTION:\n
Description
\n\neCTD Submissions of IND and NDA/BLA to the US FDA\, EU and Ca
nada
\n\n \;
\n\n*** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! ***
\nREGISTER TODAY!
\n\n \;
\n\nThe international agreement to assemble all Qua
lity\, Safety and Efficacy information for a drug or biologic product into
a common format (called the CTD - Common Technical Document) has improved
the speed and efficiency for companies working in global development prog
rams and clarified expectations by regulatory bodies. Reformatting for mul
tiple submissions is substantially limited. The CTD has improved the regul
atory review processes and enabled implementation of good review practices
. The eCTD has increased efficiency for reviewers and improved submission
times.
\n\n \;
\n\nTh
is two day workshop will provide you with an in-depth review of the conten
t and format requirements of the CTD/eCTD. Hands-on activities will includ
e organizing specific study reports and other documents into the CTD\, usi
ng tools for the project management of the CTD preparation\, and pre-publi
shing an eCTD.
\n \;\n\nWh
o will Benefit:
\n\n\n - Re
gulatory Affairs
\n - Quality A
ssurance
\n - Pharmacovigilance
\n - Project Management
\n - Regulatory Operations
\n - Medical and Technical writers
\n - Professionals preparing IND\, DM
Fs\, NDAs and other submissions
\n - IT Professionals
\n - Any
one responsible for providing content for the CTD
\n
\n
\n
\n \;
SUMMARY:eCTD Submissions of IND and NDA/BLA to the US FDA\, EU and Canada (
com) A
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SUMMARY:eCTD Submissions of IND and NDA/BLA to the US FDA\, EU and Canada (
com) A
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