BEGIN:VCALENDAR
VERSION:2.0
PRODID:icalendar-ruby
CALSCALE:GREGORIAN
BEGIN:VEVENT
DTSTAMP:20240329T155527Z
UID:ae299231-0075-48bf-9437-a6bc185dd36d
DTSTART:20211104T090000
DTEND:20211105T090000
CLASS:PRIVATE
DESCRIPTION:Course"\;eCTD Submissions of IND and NDA/BLA to the US FDA\
, EU and Canada (COM)"\; has been pre-approved by RAPS as eligible for
up to 12 credits towards a participant&rsquo\;s RAC recertification upon
full completion
\n \;\n
An Interative Workshop Pres ented BY WCS &\; Peggy J. Berry\, MBA\, RAC\, (Synergy Consulting)
\n\nThe international agreement to assemble all Quality\, Safety and Efficacy information for a drug or biologic product into a comm on format (called the CTD - Common Technical Document) has improved the sp eed and efficiency for companies working in global development programs an d clarified expectations by regulatory bodies. Reformatting for multiple s ubmissions is substantially limited. The CTD has improved the regulatory r eview processes and enabled implementation of good review practices. The e CTD has increased efficiency for reviewers and improved submission times.< /p>\n\n
Why You should Attend The Session \;
\n\ nThis two day workshop will provide you with an in-depth review of the content and format requirements of the CTD/eCTD. Hands-on activities will include organizing specific study reports and other documents into the CTD \, using tools for the project management of the CTD preparation\, and pre -publishing an eCTD
\n\n&bull\; \;&nbs
p\;  \;Overview of the drug development program and source of relevant
submission documents
\n&bull\; \; \;  \;Discussion of th
e roles and responsibilities for CTD preparation
\n&bull\; \;&nbs
p\;  \;Review of the CTD format requirements
\n&bull\; \;&nbs
p\;  \;Discussion on the successful transition from other formats to t
he CTD
\n&bull\; \; \;  \;Placement of content into the C
TD format\; including less obvious items
\n&bull\; \; \; &nbs
p\;Review of different requirements across regions (US\, EU\, Canada)
\n&bull\; \; \;  \;Implementing tools for the project managem
ent of CTD preparation and publishing
\n&bull\; \; \;  \;
Technical requirements for an eCTD submission
\n&bull\; \; \;
 \;Document naming requirements
\n&bull\; \; \;  \;B
uilding the folder structure
\n&bull\; \; \;  \;Internal
document requirements for the eCTD
\n&bull\; \; \;  \;Per
formi
&bull\; \; \;  \;
Regulatory Affairs
\n&bull\; \; \;  \;Quality Assurance\n&bull\; \; \;  \;Pharmacovigilance
\n&bull\; \;
 \;  \;Project Management
\n&bull\; \; \;  \;Regu
latory Operations
\n&bull\; \; \;  \;Medical and Technica
l writers
\n&bull\; \; \;  \;Professionals preparing IND\
, DMFs\, NDAs and other submissions
\n&bull\; \; \;  \;IT
Professionals
\n&bull\; \; \;  \;Anyone responsible for
providing content for the CTD
Re
gulatory Affairs\, Quality Assurance\, Pharmacovigilance\, Project Managem
ent\, Regulatory Operations\, Anyone responsible for providing content for
the CTD
\n
\n
\nSeminar One Registration- \;$ 1295
\nSpecial Group Discount Register for Four attendees- \; \;$ 388
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