Webinar on Implementing Best Practices for Global Regulatory Intelligence Programs

Description :

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

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