25-26 March 2010
Baltimore, MD
The RAPS Horizons Conference & Exhibition starts where traditional programs leave off, bringing together an unparalleled group of global regulatory and business leaders representing multiple healthcare product lines and full lifecycle expertise—in an environment designed specifically for experienced regulatory professionals.
- Engage in provocative dialogue and Socratic discussions led by skilled moderators
- Learn how regulatory is uniquely positioned to drive strategy and impact policy, both internally and externally
- Take away actionable strategies for success—for your organization, for your team and for you
- Interact with other high-level regulatory professionals and expand your network
Discover how you can drive strategy to impact policy and take the lead as the regulatory profession faces new challenges and changes like never before.
Keynote Speaker
Terry Paulson is a PhD psychologist, a recognized expert on change management and author of They Shoot Managers Don't They, Paulson on Change, Making Humor Work, 50 Tips for Speaking Like a Pro, and Can I Have the Keys to the Car? For more than 30 years, Dr. Paulson has been helping people around the world transform their self-limiting beliefs into self-fulfilling breakthroughs to achieve their personal and professional goals.
Session Topics
In highly-focused, in-depth education sessions, experts from around the world will speak about the impact of current regulatory guidances and trends, market innovations, new technologies and much more, challenging you to think strategically and creatively about some of the regulatory profession's most vital issues. Session topics include:
- Future Challenges for Regulatory Affairs Leaders
- Comparative Effectiveness and Healthcare Reimbursement Programs
- Emerging Markets Update
- Transparency and Global Regulatory Agencies
- Global Supply Chain Challenges
- Evolving Post Market Evaluation Expectations for Medical Devices
- Developing and Mentoring Regulatory Staff for the Global Regulatory Environment
- Impact of FDA/EMEA Changes on the Global Environment: Pharmaceuticals
- Impact of FDA/EC Changes on the Global Environment: Medical Devices
- Social Media--Benefits and Challenges
- Future Operating Environment: Virtual Organizations
- Setting Strategic Direction: A Seat at the Company Table
- Unmasking the Regulatory Function
- Emerging Regulations: Is Harmonization a Thing of the Past or Still a Hope for the Future?
- Optimizing Interactions with Agencies
- Benefit Risk Assessment--Views of the Agencies and how Industry can Best Addresses This
- Mergers and Acquisitions: Establishing an Integrated Regulatory Department
- Long Term Value: Building a Compliant Foundation in a Start-up Environment
Discover Baltimore
Nicknamed "Charm City," Baltimore is one of America's oldest cities and is well-known for its rich ethnic and maritime heritage, sense of history and food. The Hyatt Regency Baltimore sits in the heart of downtown Baltimore just steps from the beautiful Inner Harbor. The hotel's premier location within the city and the city's many attractions offer ideal informal and exciting networking opportunities. Crack crabs with colleagues on the waterfront, discover the wonders of the sea at the National Aquarium or explore the diverse neighborhoods that make Baltimore such a unique city.