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Regulatory affairs professionals must have both a solid foundation surrounding regulatory strategy and an in-depth understanding of how this plan links to the overall product development strategy to achieve efficient, cost-effective development outcomes and commercialization success.
Whether navigating a new regulatory pathway, understanding how to secure clinical data to achieve successful commercial outcomes or ensuring reimbursement strategies are coordinated with regulatory strategy throughout the planning process, it is essential all stakeholders to take steps to secure broader market success for newly developed medical technologies.
This webinar focuses on best practices and proven strategies to address challenges presented by today’s shifting regulatory environment and how early integration of regulatory, reimbursement and clinical research planning are the keys to commercial success.
- Understand how looking beyond current regulatory approaches can lead to commercial success
- Review common challenges related to the regulatory approach of “least resistance”
- Learn why regulatory approval does not always equal reimbursement
- Apply best practices to achieve effective clinical study design through early planning and integration of regulatory affairs and reimbursement requirements
- Explain how leveraging best practices and tactics linking regulatory, reimbursement and clinical strategies is key to saving time and costs throughout the development process and accelerating commercialization