NDA Submission Planning & Management from the Medical Writer’s Perspective

The session “NDA Submission Planning & Management from the Medical Writer’s Perspective” will orient the audience to New Drug Application (NDA) structure, the typical challenges faced by the medical writers during the authoring and review process, and strategies for messaging and preparing for internal and agency review.

Saturday, Oct 25, 2014

Overview

Program Summary:
NDA Submission Planning & Management from the Medical Writer’s Perspective
The session “NDA Submission Planning & Management from the Medical Writer’s Perspective” will orient the audience to New Drug Application (NDA) structure, the typical challenges faced by the medical writers during the authoring and review process, and strategies for messaging and preparing for internal and agency review.
Project Management from a Project Manager’s Perspective:
Essentials of Balancing Human Factors and Business Requirements for Project Success
The successful outcome of a project is directly attributable to the skills and experience of the Project Manager. Today’s Project Manager serves in a leadership role that extends beyond the mastery of the triple constraints of cost, scope and schedule, placing greater emphasis on communication and interpersonal skills over technical skills in interactions with the project team and with stakeholders.

CareFusion Corporation
3750 Torrey View Ct.
San Diego, CA 92130
11:30 AM – 03:30 PM Pacific

Description

NDA Submission Planning & Management from the Medical Writer’s Perspective
The session “NDA Submission Planning & Management from the Medical Writer’s Perspective” will orient the audience to New Drug Application (NDA) structure, the typical challenges faced by the medical writers during the authoring and review process, and strategies for messaging and preparing for internal and agency review. Additionally, the session will include discussion of team dynamics, the trade-off between quality and expediency in the race to NDA submission, and what follows the NDA submission for the medical writers.Project Management from a Project Manager’s Perspective:
Essentials of Balancing Human Factors and Business Requirements for Project Success
The successful outcome of a project is directly attributable to the skills and experience of the Project Manager. Today’s Project Manager serves in a leadership role that extends beyond the mastery of the triple constraints of cost, scope and schedule, placing greater emphasis on communication and interpersonal skills over technical skills in interactions with the project team and with stakeholders. This program will provide a comprehensive overview of the behavioral aspects of managing projects applying “soft skills” and communication strategies that engage and build relationships in the quest to achieve a common goal.

Speaker

Program Topic 1: NDA Submission Planning & Management from the Medical Writer’s Perspective
Program Speaker 1:
Michael Baker, Clinical Development ConsultantProgram Topic 2: Project Management, From a Project Manager’s Perspective:
Essentials of Balancing Human Factors and Business Requirements for Project SuccessProgram Speaker 2:Rachel Hernandez, PMP

Agenda

11:30 am – 12:00 pm, Registration, Open Networking
1:00 pm – 3:30 pm, Program Presentations