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
- Detailed Contents
- Common Mistakes Leading to Serious Consequences
- Speaker’s PASS-IT Recommendations: Best Practices
Who Should Attend:
- Compliance Officers
- Regulatory Affairs
- Clinical Affairs
- Quality Assurance
- Research & Development
- Anyone interested in Global Regulatory Intelligence Programs
Course Director: 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.