Significant benefits to develop and implement a regulatory plan including detailed strategies have been frequently neglected and/or undervalued. Understanding expectations and evaluating requirements and potential hurdles early in the process can save significant resources (time, energy and money) and beyond.
This seminar is intended to help you develop and implement regulatory guidelines (intelligence-based regulatory plan and strategy) using a CAC-SI method. CAC-SI in this case refers to a Current, Accurate, and Comprehensive regulatory plan and strategy in a Systematic, Integrated Manner.
In this 60-min presentation, the speaker will guide you through the details of the contents for your integration in your regulatory plan and strategy. At the end of the presentation, you should be able to come up with your practical, actionable, and sustainable solutions to your organizations.
- Applicable Laws and Regulations in EU, Canada, and US
- Questions and Issues to Identify and Address
- Interfacing: Roles and Benefits
- Alignments between Functional Departments/Groups
- What Is Critical When Implementing Global Regulatory Intelligence Program
- Mapping Regulatory Requirements and Pathways
- When/How to Prevent Costly Mistakes
- Best Approaches: What to Integrate
- Practical, Actionable, and Strategic Solutions (PASS)
- Speaker’s Experience and Actual Cases.
Dr David Lim,
President and Principal Consultant ,
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. 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 seven 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, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.
- Regulatory Affairs
- Research and Development (Engineers and Scientists); Product Development (Engineers and Scientists)
- Clinical Affairs
- Senior Management
- Contractors and subcontractors
- Anyone interested in the topic.