ParagonRx® | Minimize Risk and Optimize Use

At the conclusion of this meeting, participants should be able to:

• Discuss some of the recent advances in drug development (e.g., biomarkers and individualized medicine) and the implications of these changes to academia, industry, regulators, payers and healthcare practitioners.
• Identify new clinical trial designs and efficiencies in the process; what is the impact of the new domestic and international processes on the conduct of clinical trials?
• Explain strategies for gaining and retaining reimbursement; how are Health Technology Assessments utilized?
• Differentiate the Canadian versus international regulatory alignment; where is there movement towards alignment and where are the gaps?
• Recognize how clinical development pre- and postapproval is impacted by regulatory and market access collaboration.