Now, more than ever, the bio/pharmaceutical industry is facing substantial changes that can have profound effects on late phase research.  These studies are just the starting point of many post market obligations which can have the potential to match the costs of drug development.  Speed and execution is paramount and along with ensuring the studies are designed efficiently and effectively that meet the many requirements of varied stakeholders.  CBI’s annual forum has convened thousands of industry leaders to network and develop strategies for optimizing late phase research.  Learn how to meet the needs of diverse external constituencies with multi-faceted registries, select the rights sites and patients, deal with missing or inconsistent data – and solutions for overcoming them.   

Some of the topics include:

• Strategies for communicating effectively with regulators
• Design considerations that save money, reduce timelines and bias
• Proactive collection techniques that promote high-quality data
• Understanding full disclosure of study data and the risks of negative data in post-approval studies
• Meeting the needs of multiple stakeholders while providing a great return on investment

Sponsors/Exhibitors:

Global Foundation Sponsor:	REGISTRAT-MAPI is a global CRO dedicated exclusively to Late Phase research. For more than 20 years, we have provided quality and strategic solutions, flexible services, and scientific expertise. REGISTRAT- API has a proven record of success and is uniquely positioned to guide our clients through emerging trends in peri- and post-approval studies.  For more information, please visit http://www.registratmapi.com/
Silver Sponsors:	Outcome is the leading provider of patient registries, studies, quality improvement programs and integrated technologies for evaluating real-world outcomes. Outcome works globally with industry, government agencies, academia and medical and scientific associations to provide services and technologies focused on evaluating the safety, effectiveness, value and quality of healthcare products and services. The company has designed and implemented an industry-leading number of patient registries, including many of the largest and most well-recognized programs for disease outcomes and patient safety. Outcome is an Agency for Healthcare Research and Quality (AHRQ) DEcIDE Research Center, a component of the “Effective Health Care” initiative sponsored by the U.S. Dept. of Health and Human Services. Outcome was selected by AHRQ to lead the effort to create the patient registries handbook “Registries for Evaluating Patient Outcomes: A User’s Guide,” originally released in 2007, with a second edition due for release in 2010. Outcome leads the GRACE Initiative to develop good practice principles for the design, conduct, analysis and reporting of observational studies of comparative effectiveness (www.graceprinciples.org). Outcome is also a partner of the European Medicines Agency’s PROTECT-EU program, a member of the Innovative Medicines Initiative and a member of ENcEPP. For more information, please visit www.outcome.com.
	With over 30 years of experience, Covance’s Periapproval Services’ professionals provide distinctive insights on practical approaches that integrate experience, expertise and operational excellence of our talented and dedicated teams. Successful post-approval studies in today’s environment not only require experienced professionals but also leaders who have evolved and adapted to meet the new challenges of the post-FDAAA world. Comprehensive understanding, innovative tools and specialized processes allow our professionals to apply the necessary flexibility required to address post-marketing questions and challenges in today’s dynamic study environment. Covance’s periapproval services include Phase IIIb/IV clinical studies, registries and observational studies, risk management/REMS, epidemiology, and product safety services. Covance, with headquarters in Princeton, New Jersey, is one of the world’s largest and most comprehensive drug development services companies, with annual revenues greater than $1.5 billion and more than 8,900 employees in over 20 countries. Covance has the people, processes, client service and global resource capabilities to respond to the toughest post-marketing challenges. For more information, please visit www.covance.com.
	UBC partners with life science companies to develop and commercialize medical products, globally, by providing authoritative, impartial and timely real-world evidence that demonstrates safety, effectiveness and value. Our industry leading experts provide innovative perspectives and global strategies to deliver comprehensive evidence-generating solutions. Well-designed, efficiently-implemented, large streamlined studies, peri- post-approval programs, registries and associated services accelerate the generation of real-world evidence. For more information, please visit www.unitedbiosource.com.
Other Sponsors:

For more information or to register, please contact the Center for Business Intelligence toll free by phone at 1-800-817-8601 or via e-mail at cbireg@cbinet.com.