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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
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
Common Mistakes Leading to Serious Consequences
Speaker?s PASS-IT Recommendations: Best Practices
Who Will Benefit:
Research & Development
Anyone interested in Global Regulatory Intelligence Programs
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