Implementing Best Practices for Global Regulatory Intelligence Programs

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

Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.

membership
  Go PRIME   🛈 $ 240 SELECT
  Personal Plan 🛈 $ 3000 SELECT
  Business Plan 🛈 $ 9000 SELECT


  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance