DIA 2013 49th Annual Meeting
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Learnings from Safety Communications Across the Industry: Patients and EMA, REMS, and FDA, Physicians, and Medical Information Groups
Track : Track 06: Medical Communication, Medical Writing and Medical Science Liaison
Program Code: 369
Date: Wednesday, June 26, 2013
Time: 4:00 PM to 5:30 PM  EST
Location: 204AB
CHAIR :
 Stacey M. Fung, PharmD (SCHNON), Associate Director, Medical Communications, Genentech, A Member of the Roche Group, United States
SPEAKER (S):
 Martin Harvey-Allchurch, Esq, LLM (SPKAGY), Head of Communications, European Medicines Agency, European Union, United Kingdom
 Heidi C. Marchand, PharmD (SPKAGY), Assistant Commissioner for Special Health Issues, OC, FDA, United States
 Inessa Volonueva, PharmD,MS,RPh (SPKNON), Associate Director, Medical Information, Janssen Scientific Affairs, LLC, United States
Description
This symposium will include three presentations reviewing learnings from various safety communications initiatives. A five year experience from the EMA, experience from the FDA of incorporating safety reports to package labeling, and findings from a survey of physicians' familiarity with REMS and medical information safety responsibilities will be discussed.