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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
Featured 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.
 Clifford Goodman, PhD, is a Senior Vice President at The Lewis Group, a health care policy and human services consulting firm based in Falls Church, Virginia. He has more than 25 years of experience in such areas as technology assessment, evidence-based health care, health economics, and studies pertaining to health care innovation, regulation, and payment. His experience includes directing studies and projects for an international range of government agencies; pharmaceutical, biotechnology, and medical device companies; health care provider institutions; and professional, industry, and patient advocacy groups.
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.
Bill Mackin, PhD, RAC, senior principal consultant, director, regulatory affairs, Aptuit Consulting
Denise E. McEachern, vice president, global regulatory affairs, Bausch & Lomb
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
Build on Your Horizons Experience
If you found the Horizons Conference beneficial, we hope you will consider RAPS’ Executive Development program at the Kellogg School of Management 15-18 June. This program will help you transition into an executive position earlier in your career and features lectures from Kellogg’s top-rated, distinguished faculty. It combines case studies and interactive sessions teaching you ways to formulate and implement strategies to tackle management challenges to strategically position your company in the global marketplace. Program alumni continually rate it as one of the most insightful and beneficial experiences for building business and management expertise.
We encourage you to build from the Horizons program and take advantage of this opportunity to make an investment in your professional development that offers multiple returns. For more information, visit www.raps.org/execed/june2009.
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