RAPS Horizons Conference to Examine Important Regulatory Issues, Including Globalization, Transparency and Risks and Benefits of Social Media
Speakers to Include Officials From FDA, CMS, European Medicines Agency and More
15 March 2010
Rockville, MD, USA—The Regulatory Affairs Professionals Society (RAPS) will bring together senior-level and up-and-coming regulatory professionals in the healthcare products sector for its annual Horizons Conference & Exhibition at the Hyatt Regency Baltimore, 25–26 March. These regulatory decision makers working with pharmaceuticals, medical devices, biotechnology and other healthcare products will hear from leaders in the field and top officials from regulatory agencies, including the US Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS), the European Medicines Agency and Health Canada. Representatives from the Asian Harmonization Working Party (AHWP) and the US Agency for Healthcare Research and Quality (AHRQ) will also be speakers.
Topics to be discussed include transparency, globalization, comparative effectiveness research, the impact of changes at FDA and the European Medicines Agency, international harmonization and the benefits and challenges of social media in a highly regulated environment. Following is a sampling of sessions and speakers on tap for the conference. For the full conference agenda, visit RAPS.org/Horizons2010. Preregistration is open through 18 March.
Thursday, 25 March
- 8:30–10:00 am, Opening Keynote: Who Controls Regulatory Policy and What is the Role for the Regulatory Professional?, Daniel E. Ford, MD, MPH, vice dean for Clinical Investigation at the Johns Hopkins University School of Medicine and director of the Institute for Clinical and Translational Research
- 10:30 am–12:00 pm, Impact of FDA/European Medicines Agency Changes on the Global Environment: Pharmaceuticals, Matt Hillebrenner, chief, circulatory support and prosthetics branch, Center for Devices and Radiological Health (CDRH), FDA; Larry Spears, acting director of compliance, CDRH, FDA; Rainer Voelksen, executive, quality assurance and regulatory affairs, GE Healthcare EMEA; Deb Yoder, office of surveillance and biometrics, CDRH, FDA
- 1:30–3:00 pm, Emerging Regulations: Is Harmonization a Thing of the Past or Still a Hope for the Future?, Paul Brooks, vice president, healthcare, BSI; Michael Gropp, vice president, global regulatory strategy, Medtronic Inc.; Tim Ulatowski, director, Office of Compliance, CDRH, FDA; Jack Wong, vice president, regulatory affairs, Asia, general manager, Hong Kong, BSI
- 3:30–5:00 pm, Transparency and Global Agencies, Hilde Boone, liaison to FDA, European Medicines Agency; David Clapin, PhD, MPA, branch science advisor, health products and food branch, Health Canada; Emer Cooke, international liaison, European Medicines Agency; Sherry Leichtweis, RAC, vice president, global strategic regulatory, Abbott; Murray Lumpkin, PhD, Deputy Commissioner for International and Special Programs, FDA
Friday, 26 March
- 8:30–10:00 am, Developing and Mentoring Regulatory Staff for the Global Regulatory Environment, Linda Bowen, MSc, RAC, director, regulatory intelligence–US, sanofi-aventis; Paul Brooks, vice president, healthcare, BSI; Mark Gordon, vice president, global regulatory advocacy and policy, Boston Scientific; Susan James, vice president, worldwide regulatory affairs, compliance and quality, GlaxoSmithKline Consumer Healthcare; Cecilia Kimberlin, PhD, RAC, vice president, Abbott quality and regulatory, strategic deployment, quality assurance, regulatory and medical, Abbott
- 10:30 am–12:00 pm, Plenary: Leaders Make Change Work, Terry Paulson, PhD psychologist, recognized expert on change management and author
- 1:30–3:00 pm, Comparative Effectiveness and Healthcare Reimbursement, Rebecca Hoffman, MD, divisional vice president, medical affairs, Abbott quality and regulatory, Abbott Laboratories; Louis Jacque, MD, director, coverage and analysis group, CMS; Tamara Syrek Jensen, deputy director, coverage and analysis group, CMS; Jean Slutsky, PA, MSPH, director, Center for Outcomes and Evidence, AHRQ
- 3:30–5:00 pm, Social Media—Benefits and Challenges, Violet Aldaia, executive vice president, director of branding and strategic marketing, BrandEdge Global; Glenn Byrd, MBA, RAC, director, regulatory affairs, MedImmune LLC; Ilyssa Levins, president and founder, Center for Communication Compliance; O. Reed Tarwater, PhD, director, pharmaceutical consulting services, The Anson Group
Members of the working media wishing to cover all or part of the 2010 RAPS Horizons Conference & Exhibition should contact RAPS Senior Communications Manager Zachary Brousseau at zbrousseau@raps.org or +1 301 770 2920, ext. 245.
About RAPS
The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. Regulatory professionals play vital roles in making better healthcare products possible. They work throughout the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession by providing education and training, Regulatory Affairs Certification (RAC), professional standards, research, knowledge-sharing, publications, networking, career development opportunities and other valuable resources; and is committed to helping its members continually develop the knowledge and skills they need to excel. RAPS is headquartered near Washington, DC, with offices in Brussels and Tokyo. RAPS.org