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
Horsham, PA, USA (Vocus) June 6, 2009
The Drug Information Association (DIA) 45th Annual Meeting is the biopharmaceutical industry's largest and longest running global, multidisciplinary conference featuring sessions and preconference tutorials on issues affecting drug discovery and development, including two timely sessions reflecting the state of today's global biopharmaceutical environment.
The public policy/law track features a special session on Labeling Risk: Practical Approaches after Wyeth v. Levine (June 22; 1:30 - 3:00 pm).
In March 2009, The Wall Street Journal reported that the Supreme Court ruling in Wyeth v. Levine stated 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.
- 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 a timely session on Regulatory Methods to Facilitate the Approval of Biological Products to Address Pandemic Influenza (June 22, 1:30 - 3:00 pm).
This session incorporates descriptions of novel regulatory mechanisms for vaccine approval with a discussion of successful applications for pandemic influenza.
"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.
- 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
About the Drug Information Association (DIA)
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.
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