A clinical drug development scientist with more than 20 years experience in the pharmaceutical industry. Special expertise in US and European regulatory submissions in several therapeutic areas. Strong knowledge of clinical trial design and data analysis.
David has 12 yrs of scientific communications experience in the pharmaceutical industry, both within the regulatory, publications, and promotional functions. His work includes document authoring, team management, and operations consulting. He currently is a Clinical Research Scientist at Eli Lilly.
Nancy Katz, Illyria Consulting Group, Inc., United States
Nancy is President of Illyria Consulting Group, Inc., which specializes in eCTD-compliant documents. She served on the MW SIACs Core Committee for 4 years. She now chairs the SIAC's ICH E3 force and Education Committee. She is President of the Northern California chapter of AMWA.
Description
In this showcase, we will examine how medical writers in the SIACs are participating in regulatory and professional forums to improve the exchange of information, and describe what those changes may look like. We will focus on what we need to accomplish in the next 5 to 10 years to better meet medical communication needs. Our objective is to inform members about policy discussions and to encourage SIAC members to participate in these forums. Developed by the Medical Writing (MW) SIAC.
Learning Objectives: Recognize Medical Writing contributions and opportunities to influence medical communication policy Discuss global developments in regulatory and publication policy/guidance.