Combination Products Compliance & Regulatory Summit
Venue: Hyatt Regency Baltimore
Location: Baltimore, Maryland, United States
Event Date/Time: Sep 23, 2010 | End Date/Time: Sep 24, 2010 |
Description
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