BEGIN:VCALENDAR
VERSION:2.0
PRODID:icalendar-ruby
CALSCALE:GREGORIAN
X-WR-CALNAME:Investigational New Drug (IND) Applications
X-WR-TIMEZONE:Eastern Time (US & Canada)
BEGIN:VEVENT
DTSTAMP:20261012T064541Z
UID:tag:localist.com\,2008:EventInstance_39199605340544
DTSTART:20220324T130000Z
DTEND:20220324T160000Z
DESCRIPTION:The Regulatory Department is the key contact with regulatory ag
 encies. Regulatory must prepare documents that inform the agency about the
  proposed development plan\, keep the agency up to date and answer any que
 stions the agency has about an on-going investigation\, request and prepar
 e for meetings with the agency to discuss development plans\, construct an
 d write the marketing application and submit any updates to the marketing 
 application in a concise and informative manner.\n\nSubmissions to a regul
 atory agency involve more than just writing. They also encompass strategy\
 , editing\, publishing and systematic tracking of key information. Through
  lectures\, case studies\, and hands-on exercises\, new and experienced re
 gulatory professionals learn how to work with the regulations\, guidance d
 ocuments and style guides to produce submissions that comply with the requ
 irements and are clear to the reviewers.\n\nIn this practical workshop\, a
 pproved drug labels and summary basis of approvals are used to help studen
 ts acquire the knowledge and insight needed to understand and begin to con
 struct core U.S. drug and biologics submissions\, including pre-marketing 
 and marketing applications. Participants also gain experience with tools t
 hat help manage timelines and sections needed from contributors.\n\nLearni
 ng Objectives\n\nFind the required regulations and guidance documents for 
 drug and biologic submissions.Use regulations and guidance documents to ou
 tline and construct a variety of drug and biologic submissions.Formulate a
  working knowledge of regulatory submissions\, publishing\, and style guid
 es.Create checklists that encompass timelines and sections needed from con
 tributors.Course Outline\n\nFood and Drug Adminstration (FDA) Division Inf
 ormation\n\nSubmission basics - outlining the submission\, creating the Ta
 ble of Contents\, timing of submission/timelines\, contributions from othe
 r departments\, editing\, style guides\, templates\, supportive documents\
 , Quality-Assuring (QAing) the submissionPublishing the Submission\n\nSubm
 ission publishing basicsCopies (how many to make and keep)Introduction to 
 electronic publishing requirementsTracking the Submissions\n\nCreating the
  index historyCreating an issues logCommon Technical Document (CTD) format
 Pre-Market\n\nFDA meetings (Type A\, B and C): phase I\, phase II\, end of
  phase II\, requesting the meeting\, preparing the meeting package\, meeti
 ng minutesAdditional submissions: fast track\, orphan drug\, special proto
 col assessmentThe submissionRoutine submissions: clinical submissions\, no
 n-clinical submissions\, annual reports\, investigator brochure updates\, 
 protocol amendments\, investigatorsMarketing Application\n\nNon-Disclosure
  Agreements (NDAs) in a CTD format
LOCATION:
SUMMARY:Investigational New Drug (IND) Applications
URL;VALUE=URI:https://events.weill.cornell.edu/event/investigational_new_dr
 ug_ind_applications
CATEGORIES:Lecture/Seminar
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20261012T064541Z
UID:tag:localist.com\,2008:EventInstance_39202091311175
DTSTART:20220331T130000Z
DTEND:20220331T160000Z
DESCRIPTION:The Regulatory Department is the key contact with regulatory ag
 encies. Regulatory must prepare documents that inform the agency about the
  proposed development plan\, keep the agency up to date and answer any que
 stions the agency has about an on-going investigation\, request and prepar
 e for meetings with the agency to discuss development plans\, construct an
 d write the marketing application and submit any updates to the marketing 
 application in a concise and informative manner.\n\nSubmissions to a regul
 atory agency involve more than just writing. They also encompass strategy\
 , editing\, publishing and systematic tracking of key information. Through
  lectures\, case studies\, and hands-on exercises\, new and experienced re
 gulatory professionals learn how to work with the regulations\, guidance d
 ocuments and style guides to produce submissions that comply with the requ
 irements and are clear to the reviewers.\n\nIn this practical workshop\, a
 pproved drug labels and summary basis of approvals are used to help studen
 ts acquire the knowledge and insight needed to understand and begin to con
 struct core U.S. drug and biologics submissions\, including pre-marketing 
 and marketing applications. Participants also gain experience with tools t
 hat help manage timelines and sections needed from contributors.\n\nLearni
 ng Objectives\n\nFind the required regulations and guidance documents for 
 drug and biologic submissions.Use regulations and guidance documents to ou
 tline and construct a variety of drug and biologic submissions.Formulate a
  working knowledge of regulatory submissions\, publishing\, and style guid
 es.Create checklists that encompass timelines and sections needed from con
 tributors.Course Outline\n\nFood and Drug Adminstration (FDA) Division Inf
 ormation\n\nSubmission basics - outlining the submission\, creating the Ta
 ble of Contents\, timing of submission/timelines\, contributions from othe
 r departments\, editing\, style guides\, templates\, supportive documents\
 , Quality-Assuring (QAing) the submissionPublishing the Submission\n\nSubm
 ission publishing basicsCopies (how many to make and keep)Introduction to 
 electronic publishing requirementsTracking the Submissions\n\nCreating the
  index historyCreating an issues logCommon Technical Document (CTD) format
 Pre-Market\n\nFDA meetings (Type A\, B and C): phase I\, phase II\, end of
  phase II\, requesting the meeting\, preparing the meeting package\, meeti
 ng minutesAdditional submissions: fast track\, orphan drug\, special proto
 col assessmentThe submissionRoutine submissions: clinical submissions\, no
 n-clinical submissions\, annual reports\, investigator brochure updates\, 
 protocol amendments\, investigatorsMarketing Application\n\nNon-Disclosure
  Agreements (NDAs) in a CTD format
LOCATION:
SUMMARY:Investigational New Drug (IND) Applications
URL;VALUE=URI:https://events.weill.cornell.edu/event/investigational_new_dr
 ug_ind_applications
CATEGORIES:Lecture/Seminar
END:VEVENT
END:VCALENDAR