Combination Products Regulatory & Compliance Summit

In an era of regulatory scrutiny and anticipated enforcement actions for non-compliance, The Combination Products Regulatory & Compliance Summit provides actionable strategies to respond to current activity at the Office of Combination Products to protect proprietary information and create strategic partnerships to profitably leverage your existing portfolio.

From partner contracting to reimbursement, get it right every step of the way:

• Anticipate combination product activity at the FDA to remain compliant
• Establish common product goals with your partners to ensure easy & efficient FDA relations
• Learn what the FDA looks for in combination product clinical trials to avoid early life-cycle missteps
• Navigate registration & listing requirements to steer clear of FDA scrutiny
• Interpret auto-injector guidance ambiguities to compliantly adapt best practices
• Comply with mutually conforming labeling requirements to design safe combination products
• Minimize enforcement risk through cGMP compliance
• Distinguish global regulations to build a successful combination product marketing blueprint
• Position your business plan to bridge the gap between safety and adverse event reporting
• Understand coverage and coding policy to get reimbursed for a combination product

Distinguished 2010 Speaking Faculty
John Kinzell President & CEO XERIS PHARMACEUTICALS	Eric Edwards Co-Founder & Chief Scientist INTELLIJECT	Bradley Merrill Thompson Shareholder, Health Care and Life Sciences Practice EPSTEIN, BECKER & GREEN, P.C.
Michael Gross Senior Consultant BIOLOGIC CONSULTING GROUP	Asif Sidiqui Director, Regulatory Affairs ROCHE MOLECULAR SYSTEMS	Suzanne Kiani Senior Scientist, CMC Regulatory Affairs GENENTECH