Track
:
Track 06: Medical Communication, Medical Writing and Medical Science Liaison
Program Code:
271
Date:
Tuesday, June 25, 2013
Time:
4:00 PM to 5:30 PM
EST
Location:
204AB
CHAIR
:
Linda Fossati Wood, MPH,RN (SCHNON, President, MedWrite, Inc., United States
Linda Wood has provided regulatory writing services to the drug and medical device industries for 20 years. She founded DIA’s Medical Writing SIAC, and co-authored the first comprehensive book on regulatory writing, Targeted Regulatory Writing Techniques:Clinical Documents for Drugs and Biologics.
SPEAKER
(S):
Anne B. Cropp, PharmD (SCHNON), Executive Director, Pfizer Inc, United States
Anne Cropp is Clinical Group Head at Pfizer Inc. She serves as cross-line expert for various operational efficiencies and is Business Lead for a global Protocol Development Process Improvement effort that has significantly improved cycle time of protocol development and reduced amendments.
Kenneth A. Getz, MBA (SPKSUP), Director of Sponsored Research, Tufts CSDD; Chairman, CISCRP, Tufts University, United States
Ken is the chairman of CISCRP, and the Director of Sponsored Research / Associate Professor at Tufts CSDD. He is a well-known speaker and author, and serves on a number of for-profit and not-for-profit boards and committees. Ken holds an MBA from the Kellogg School of Management at Northwestern U.
Kimberly Jochman, PhD (SPKNON), Manager, Global Medical Writing, PPD, United States
Kimberly Jochman has been with PPD since 2007. As manager of Phase 2-4 North American (NA) medical writing staff, Kimberly oversees and coordinates medical writing activities across the US and also functions as a medical writing program manager for one of PPD’s key alliance partnerships.
Description
This symposium will discuss current trends in protocol characteristics and explore a variety of strategies for development of a successful protocol. Clinical protocols have become increasingly complex in the past decade and, consequently, initiatives have been developed to improve efficiency and quality and reduce the impact of amendments through protocol design. The advantages gained by engaging a medical writer in the review of study documents initiated by other departments such as the case report forms and the statistical analysis plan will be discussed.