Global regulatory agencies including the United States Food and Drug Administration (FDA) review, approve/register or clear regulatory applications for drugs, biologics and/or medical devices including in vitro diagnostic devices (IVDs). It is imperative that firms identify and map evolving regulatory requirements so that regulatory submissions can be better prepared for and managed with awareness in advance.
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