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
Stacey Fung is in Medical Communications at Genentech. She received a PharmD, and completed a pharmacy practice residency and a drug information residency. Prior to Genentech, she held positions in Medical Affairs at Chiron Therapeutics and Protein Design Labs.
SPEAKER
(S):
Martin Harvey-Allchurch, Esq, LLM (SPKAGY), Head of Communications, European Medicines Agency, European Union, United Kingdom
Law degrees from University of Dundee, UK, and Vrije Universiteit Brussel, Belgium. European affairs consultant in Brussels from 1992 to 1995. Joined EMA legal team in September 1995. Headed the Office of the Executive Director from 2004 to 2012. Appointed Head of Communciations in February 2012.
Heidi C. Marchand, PharmD (SPKAGY), Assistant Commissioner for Special Health Issues, OC, FDA, United States
Heidi Marchand, Pharm.D. is currently with the FDA. She has held leadership positions in global regulatory affairs with Novartis, Pfizer and Amgen. Dr. Marchand leads FDA’s initiative to collaborate with AACP to evaluate Colleges of Pharmacy’s curriculum dealing with the “science of safety”.
Inessa Volonueva, PharmD,MS,RPh (SPKNON), Associate Director, Medical Information, Janssen Scientific Affairs, LLC, United States
Graduate of St John’s University (Pharm D) and Arnold and Mary Schwartz College of Pharmacy (MS, R.Ph). Medical Information experience: Janssen Scientific Affairs (Associate Director, Oncology Medical Information) and Bristol-Myers Squibb Company, the NewYork-Presbyterian Hospital Drug Info Center.
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.