Preparation of Clinical Study Reports and Summary Documents: Maximize Efficiency and Minimize Redundancy
Track
:
Track 06: Medical Communication, Medical Writing and Medical Science Liaison
Program Code:
232
Date:
Tuesday, June 25, 2013
Time:
10:15 AM to 11:45 AM
EST
Location:
204AB
CHAIR
:
Pamela Lindroos, PhD (SCHNON), Senior Director, Medical Writing, WebbWrites, LLC, United States
Dr. Lindroos has been a medical writer at WebbWrites since 1998. She received a PhD in pathology from Duke University in 1992 and was a postdoctoral researcher at the National Institute of Environmental Health Sciences from 1993-1998.
SPEAKER
(S):
Pamela Lindroos, PhD (SPKNON), Senior Director, Medical Writing, WebbWrites, LLC, United States
Dr. Lindroos has been a medical writer at WebbWrites since 1998. She received a PhD in pathology from Duke University in 1992 and was a postdoctoral researcher at the National Institute of Environmental Health Sciences from 1993-1998.
Kristina Brannstrom, PhD (SPKNON), Director and Regional Head, Global Medical Writing and Document Publishing, Quintiles Inc., United States
Kristina joined Quintiles in 1999 as a medical writer and her responsibilities have included writing regulatory documents such as Protocols, CSRs, Integrated Summaries of Safety and Efficacy, IBs and IND Annual Reports. Since 2012, Kristina is the regional head of medical writing for the US.
Helen Colquhoun, MD,FFPM (SPKNON), Senior Vice President, CROMSOURCE, United States
Helen is Senior Vice President of Cromsource Inc and is a physician with more than 24 years' industry experience, with expertise in regulatory affairs, negotiations with regulators, clinical study design and management, drug safety management, combination product development, and crisis management.
Description
This forum will discuss how the preparation of high-quality clinical study reports (CSRs) and summary documents for a New Drug Application (NDA) may be achieved by preparation of shell documents, adherence to guidance documents, avoidance of redundancy within and across documents, and structured authoring.