Growing demands from regulators for postmarket-approval data along with the need for data to support commercial markets are fueling biotech company product and disease registries. This session will guide the audience through the decision-making, structuring, legal/regulatory, implementation and operational components of establishing and operating a global product/disease registry.



Objectives:

Understand when a disease/product registry is desirable or required (as compared with a clinical trial), and factors for reaching a decision by your company when starting a registry.

Understand the important considerations when designing, structuring, implementing and operating a global registry, with exposure to concrete examples of decision points at each step.

Learn proactive strategies for cost-effectively identifying and resolving complex regulatory and operational aspects of these arrangements in advance.