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1-3 April 2009
San Francisco
The Fairmont San Francisco
Program Description
The 2009 RAPS Horizons Conference & Exhibition challenges experienced regulatory professionals to think strategically and creatively about some of the regulatory profession’s most vital issues. In highly-focused, in-depth education sessions, key international opinion leaders will speak provocatively about the impact of current regulatory guidances and trends, market innovations, new technologies and much more!
Cutting across product lines and addressing all areas of the typical product lifecycle, the 2009 RAPS Horizons Conference & Exhibition is the one conference that promotes critical thinking about today’s hottest topics, challenges you to examine out-of-the-box solutions and gives you the tools you need to excel in your career.
Learning Objectives
At the conclusion of this program, participants should be able to:
- Assess emerging technologies and current trends in the product development and registration process
- Design and integrate comprehensive regulatory strategies and business management plans
- Identify tools and assess risks when preparing for product launch
- Recommend measures for minimizing postapproval challenges
Who Should Attend?
Mid- and senior-level regulatory professionals involved in research, development, preclinical, regulatory submission, manufacturing and postmarketing aspects of healthcare products should mark their calendars to attend this thought-provoking program. The conference will also be extremely valuable for those involved in legal affairs, marketing, policy-making and reimbursement areas.
Facilitating in-depth examination of topics that directly impact their ability to succeed in today’s fast-paced regulatory environment, this conference is a not-to-miss program!
Levels: II, III, IV
Speakers
Keynote Speaker: Andrew Hargadon
Andrew Hargadon is an associate professor of technology management at the Graduate School of Management and director of the Center for Entrepreneurship and the Energy Efficiency Center at University of California, Davis. Professor Hargadon’s research focuses on the effective management of innovation and the strategic role of design in managing technology transitions.
Closing Plenary Speaker: Dr. Kellie McElhaney
Kellie McElhaney is the John c. Whitehead Distinguished Faculty Fellow in Corporate Responsibility and founding director of the Center for Responsible Business at the Haas School of Business, University of California, Berkeley. She developed and launched the center in January 2003. She consults for many Fortune 500 companies and was named a 2005 Faculty Pioneer for Institutional Leadership in the Aspen Institute’s biennial report, Beyond Grey Pinstripes.
Discover San Francisco
San Francisco is often called “Everybody’s City,” a title earned by its scenic beauty, cultural attractions, diverse communities and world class cuisine. This unique and breathtaking metropolis is known for its colorful past, steep rolling hills and a variety of sites, shops and restaurants that reflect this city’s great ethnic and cultural diversity. Dotted with landmarks like the Golden Gate Bridge, cable cars, Fisherman’s Wharf and the largest Chinatown in the United States, it is no wonder this city’s countless charms make it one of America’s most popular destinations.
Program Planning Committee
Susan E. James, vice president, worldwide regulatory affairs, R&D compliance and quality, consumer healthcare, GlaxoSmithKline - Chair
Korina A. Akhondzadeh, senior regulatory consultant, KARA & Associates Inc.
Paul C. Brooks, vice president and country manager, BSI PS Healthcare
Glenn N. Byrd, RAC, director, regulatory affairs, MedImmune Inc.
William M. Mackin, PhD, RAC, consultant, Aptuit Consulting
Denise E. McEachern, vice president, regulatory affairs, Ensure Medical Inc.
Donald A. Middlebrook, vice president, corporate quality assurance and regulatory affairs, Thoratec Corporation
O. Reed Tarwater, PhD, RAC, director, pharmaceutical services, The Anson Group LLP
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