In March 2009, the Supreme Court ruled in Wyeth v. Levine that pharmaceutical companies are not necessarily shielded from failure to warn product liability lawsuits in state courts when the US FDA has determined that approved labeling appropriately explains risk information. This session will explore practical approaches pharmaceutical companies should consider when disseminating risk information to minimize failure to warn liability and to maximize the possibility such liability is preempted.
“We will delve deep into the legal benefits of preemptions, describe regulatory and documentation strategies that maximize the availability of preemption in failure-to-warn lawsuits, and identify effective risk communication strategies,” says Session Chair Patrick C O’Brien, JD, PharmD, Partner, Burke O’Neil LLC, United States.
Speakers include:
- John B Moriarty, JD, Senior Vice President, Elan Pharmaceuticals, United States
- Sandra A. Milligan, JD, MD, Executive Director, Amgen Inc., United States
- Mary K. Pendergast, JD, LLM, President, Pendergast Consulting, United States
This year’s biotechnology track includes atimely session on Regulatory Methods to Facilitate the Approval of Biological Products to Address Pandemic Influenza (June 22, 1:30 – 3:00 pm).
“This must-attend session will attempt to identify novel regulatory approaches to vaccine approval, industry approaches toward interactions with the FDA, and novel biochemical methods for the development of vaccines,” explains Session Chair Richard M Lewis, PhD, CEO, Access BIO, United States.
Speakers include:
- Jean L Hu-Primmer, MS, Program Manager, Pandemic and Emerging Threat Preparedness, OD, CBER, USFDA
- John Purves, PhD, Head of Sector, Quality of Medicines, European Medicines Agency
- Ozzie Berger, Senior Director and Head, Influenza Vaccines, US Regulatory Affairs, Biologicals, GlaxoSmithKline
DIA serves more than 30,000 professionals involved in the biopharmaceutical industry and regulatory affairs worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes. Headquartered in Horsham, PA, USA, and with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China, the Association is led by its volunteer-based Board of Directors and executive management team. For more information, visit www.diahome.orgor call
215-442-6100
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Contact: Joe Krasowski
+1-215-293-5812Joe.Krasowski@diahome.org
Bonnie Shaw
+1-858-724-2500