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This seminar is intended to discuss the best practices for implementing Global Regulatory Intelligence (GRI) programs including dos and don?ts. This seminar is further intended to discuss how to implement a holistic global regulatory intelligence program suitable for your medical product types. Establishing a practical, actionable and sustainable regulatory intelligence program can help an organization save a significant amount of resources (time, efforts and financial). In this seminar, the speaker will discuss what firms should consider and address when implementing a holistic global regulatory intelligence program. Areas Covered in the Session : Applicable Laws and Regulations Definitions Guidance, Rules, and Standards What to Consider for Regulatory Intelligence of Medical Products Questions and Issues to Identify and Address Totality and Flexible Approaches Interfacing: Roles and Benefits Reimbursement and Intellectual Property (IP) Issues Alignment between Regulatory Plan/Strategy, Reimbursement, and IP What to Integrate Detailed Contents Common Mistakes Leading to Serious Consequences Speaker?s PASS-IT Recommendations: Best Practices Who Will Benefit: CEOs VPs Compliance Officers Attorneys Regulatory Affairs Clinical Affairs Quality Assurance Research & Development Consultants Contractors/Subcontractors Anyone interested in Global Regulatory Intelligence Programs
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