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Efficient Authoring of Submission Documents
Session Chair(s)
Linda Fossati Wood
President
MedWrite, Inc., United States
This symposium will discuss the processes around the preparation of complex summary documents included in Investigational New Drug (IND) applications and New Drug Applications (NDA). We will explore options for planning the timing for authoring Modules 2.4 through 2.7 of the IND and integrated and clinical summaries of the NDA to maximize efficiency and capitalize on synergies between the different documents. We will discuss approaches for handling common challenges and significant changes in scope while still maintaining high-quality deliverables that meet submission deadlines.
Learning Objective : Describe timing for authoring of Modules 2.4-2.7 of an Investigational New Drug (IND) and integrated and clinical summaries of an New Drug Applications (NDA); Propose alternate strategies for completion of these documents when issues arise (ex, changes in project scope or timing, data issues, source report delays.)
Speaker(s)
Optimal Strategies for Preparing Integrated Summaries for a New Drug Application: Making it Work Under Any Circumstance
Lisa Pierchala, MPH
MMS Holdings Inc., United States
Principal Medical Writer
So Many Documents, So Little Time: Optimizing the Authoring of the IND From Planning to Publishing
Rachael Eckert, DVM, PhD
PPD (part of Thermo Fisher Scientific), United States
Director, Medical Writing